Testosterone (Lexi-Drugs)

ALERT: US Boxed Warning
  Blood pressure increases (SubQ testosterone enanthate)
  Secondary exposure (transdermal gel, transdermal solution):
  Pulmonary oil microembolism (testosterone undecanoate):
Drug Shortages

One or more forms of this drug may be in short supply or unavailable. Refer to the following for additional information:

ASHP: http://www.ashp.org/menu/DrugShortages

Pronunciation

(tes TOS ter one)

Brand Names: US

Androderm; AndroGel; AndroGel Pump; Aveed; Axiron [DSC]; Depo-Testosterone; Fortesta; Natesto; Striant; Testim; Testopel; Vogelxo; Vogelxo Pump; Xyosted

Brand Names: Canada

Andriol [DSC]; Androderm; AndroGel; Axiron [DSC]; Delatestryl; Depo-Testosterone; Natesto; PMS-Testosterone Enhanthate [DSC]; PMS-Testosterone Undecanoate; TARO-Testosterone; Testim

Pharmacologic Category

Androgen

Dosing: Adult

Note: Testosterone enanthate IM formulation and testosterone enanthate SubQ formulation are not to be used interchangeably.

Breast cancer (females): IM (testosterone enanthate): 200 to 400 mg every 2 to 4 weeks

Delayed puberty (males):

IM (testosterone enanthate): 50 to 200 mg every 2 to 4 weeks for a limited duration (eg, 4 to 6 months)

Pellet (for subcutaneous implantation): 150 to 450 mg every 3 to 6 months. Dosing is generally at the lower range for a limited duration (eg, 4 to 6 months).

Hormone therapy in transgender males(female-to-male), monotherapy(off-label use):

IM (testosterone enanthate or testosterone cypionate): 100 to 200 mg every 2 weeks or 50 to 100 mg every week (ES [Hembree 2017])

IM (testosterone undecanoate): 1 g every 6 weeks for the first 2 doses, followed by 1 g every 12 weeks (ES [Hembree 2017]; Pelusi 2014; Wierckx 2014)

SubQ (testosterone enanthate): 50 to 100 mg every week (ES [Hembree 2017])

Topical:Gel: Androgel 1.62%: 50 to 100 mg daily (ES [Hembree 2017])

Hypogonadism (primary) or hypogonadism (hypogonadotropic) (males):

Note: Adjust therapy to achieve symptom improvement and normalization of testosterone levels. A total testosterone goal in the mid-normal therapeutic range (eg, 450 to 600 ng/dL for most laboratories) is reasonable for most patients to prevent over- or under-treatment (AUA [Mulhall 2018]). For injectable formulations (IM, SubQ), a range of 350 to 600 ng/dL may be reasonable (Endocrine Society [Bhasin 2018]; Xyosted manufacturer labeling). Dose titration is not necessary if complete symptom resolution occurs with testosterone levels below the suggested target range (AUA [Mulhall 2018]).

Buccal: 30 mg twice daily (every 12 hours) applied to the gum region above the incisor tooth.

IM (testosterone enanthate or testosterone cypionate):

Initial: 75 to 100 mg/week or 150 to 200 mg every 2 weeks; dosage range: 50 to 100 mg/week or 100 to 200 mg every 2 weeks (AUA [Mulhall 2018]; Endocrine Society [Bhasin 2018])

Manufacturer labeling: Dosing in the prescribing information may not reflect current clinical practice. 50 to 400 mg IM every 2 to 4 weeks.

IM (testosterone undecanoate): Initial: 750 mg, followed by 750 mg administered 4 weeks later, then 750 mg administered every 10 weeks thereafter.

Intranasal: Testosterone gel: Natesto: 11 mg (2 pump actuations; 1 actuation per nostril) intranasally 3 times daily (6 to 8 hours apart). Total daily dose: 33 mg

Oral (Andriol [Canadian product]): Initial: 120 to 160 mg daily in 2 divided doses for 2 to 3 weeks; usual maintenance dose: 40 to 120 mg/day (in divided doses)

Pellet (for subcutaneous implantation): 150 to 450 mg every 3 to 6 months

SubQ (testosterone enanthate): Initial: 75 mg once weekly. Dosage range: 50 to 100 mg once weekly.

Topical:

Gel:

AndroGel 1%: Initial: 50 mg applied once daily in the morning to the shoulder and upper arms, or abdomen. Dosage range: 50 to 100 mg/day.

AndroGel 1.62%: Initial: 40.5 mg applied once daily in the morning to the shoulder and upper arms. Dosage range: 20.25 mg to 81 mg/day; maximum: 81 mg/day.

Fortesta: Initial: 40 mg once daily in the morning. Apply to the thighs. Dosing range: 10 to 70 mg/day; maximum: 70 mg/day

Testim: Initial: 50 mg applied once daily (preferably in the morning) to the shoulder and upper arms. If testosterone concentrations are less than the normal range, dosage may be increased from 50 mg to 100 mg once daily; maximum: 100 mg/day.

Vogelxo: Initial: 50 mg applied once daily in the morning to the shoulder and/or upper arms. Dosage may be increased to a maximum of 100 mg/day.

Solution (Axiron): Initial: 60 mg once daily (dosage range: 30 to 120 mg/day). Apply to the axilla at the same time each morning.

Transdermal system (Androderm):

Initial: 4 mg/day (as one 4 mg/day patch; do not use two 2 mg/day patches). Dosage range: 2 to 6 mg/day

Dosing conversion: The 2.5 mg/day and the 5 mg/day patches have been discontinued in the US; patients may be switched from the 2.5 mg/day patch, 5 mg/day patch, or the combination (ie, 7.5 mg/day) as follows:

From 2.5 mg/day patch to 2 mg/day patch

From 5 mg/day patch to 4 mg/day patch

From 7.5 mg daily (one 2.5 mg/day and one 5 mg/day patch) to 6 mg daily (one 2 mg/day and one 4 mg/day patch)

Note: Patch change should occur at the next scheduled dosing. Measure early morning testosterone concentrations ~2 weeks after switching therapy.

Dosing: Geriatric

Refer to adult dosing. Some data suggest a slightly lower testosterone target may be reasonable in older patients (eg, the lower end of the normal testosterone range) (AUA [Mulhall 2018]).

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). May enhance edema formation. Testosterone cypionate is contraindicated in serious renal disease.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). May enhance edema formation. Testosterone cypionate is contraindicated in serious hepatic disease.

Dosing: Pediatric

Note: Dosage and duration of therapy depend upon age, sex, diagnosis, patient’s response to therapy, and appearance of adverse effects; in general total doses >400 mg/month are not required due to the prolonged action of the drug.

Constitutional delay of growth and puberty (CDGP):

IM:

Children ≥12 years and Adolescents ≤17 years: Note: Typically not recommended for use before 14 years of age (Palmert 2012; Sperling 2014): Initial: Enanthate or cypionate: 50 mg/dose every 2 to 4 weeks for 3 to 6 months; may increase dose in 25 to 50 mg increments for another 3 to 6 months to effect; maximum dose: 100 mg; typical duration of therapy: 12 months; if no response or inadequate response after 1 year of treatment, diagnosis should be reconsidered and additional testing performed (Palmert 2012; Sperling 2014); Note: Other regimens have suggested high initial doses and taper downward as puberty progresses.

Adolescents ≥18 years: Enanthate: 50 to 200 mg every 2 to 4 weeks for a limited duration (eg, 4 to 6 months)

Subcutaneous implant: Pellet: Children ≥12 years and Adolescents: Usual range: 150 to 450 mg every 3 to 6 months; usual duration: 4 to 6 months; dosing typically on the lower end of range; various regimens have been used

Male hypogonadism or hypogonadotropic hypogonadism:

IM: Enanthate or cypionate:

Children ≥12 years and Adolescents ≤17 years:

Initiation of pubertal growth: 25 to 75 mg every 3 to 4 weeks, gradually titrate dose every 6 to 9 months to 100 to 150 mg monthly; some experts suggest increasing the interval to every 2 weeks at this point; typical duration of initiation therapy 3 to 4 years (Han 2010; Sperling 2014; Wales 2012)

Maintenance therapy: 200 to 250 mg every 3 to 4 weeks; once expected adult height and adequate virilization achieved, may convert to other testosterone replacement dosage form (eg, patch, gel, etc) (Han 2010; Sperling 2014; Wales 2012)

Adolescents ≥18 years: 50 to 400 mg every 2 to 4 weeks (manufacturer’s labeling); 75 to 100 mg/week or 150 to 200 mg every 2 weeks (Endocrine Society [Bhasin 2010])

IM: Undecanoate: Aveed: Adolescents ≥18 years: Initial dose: 750 mg, followed by 750 mg administered 4 weeks later, then 750 mg administered every 10 weeks thereafter.

Subcutaneous implant: Pellet:

Fixed dosing: Children ≥12 years and Adolescents: Usual range: 150 to 450 mg every 3 to 6 months; various regimens have been used

Weight-direct dosing: Limited data available: Children ≥12 years and Adolescents <17 years: 8 to 10 mg/kg/dose every 6 months (Zacharin 1997)

Topical: Adolescents ≥18 years:

Buccal: Striant: 30 mg twice daily (every 12 hours) applied to the gum region above the incisor tooth; discontinue if serum testosterone concentrations are consistently outside of the normal range.

Dermal:

Gel:

AndroGel 1%: 50 mg applied once daily in the morning to the shoulder and upper arms or abdomen. Dosage may be increased to a maximum of 100 mg. Dose adjustment based on serum testosterone levels:

Less than normal range: Increase dose from 50 mg to 75 mg or from 75 mg to 100 mg once daily

Greater than normal range: Decrease dose. Discontinue if consistently above normal at 50 mg daily.

AndroGel 1.62%: 40.5 mg applied once daily in the morning to the shoulder and upper arms; dose range: 20.25 to 81 mg. Maximum daily dose: 81 mg/day. Dose adjustment based on serum testosterone levels:

>750 ng/dL: Decrease dose by 20.25 mg/day

350 to 750 ng/dL: Maintain current dose

<350 ng/dL: Increase dose by 20.25 mg/day

Fortesta: 40 mg once daily in the morning. Apply to the thighs. Dosing range: 10 to 70 mg/day. Dose adjustment based on serum testosterone levels:

≥2,500 ng/dL: Decrease dose by 20 mg/day

≥1,250 to <2,500 ng/dL: Decrease dose by 10 mg/day

≥500 and <1,250 ng/dL: Maintain current dose

<500 ng/dL: Increase dose by 10 mg/day

Testim: 50 mg applied once daily (preferably in the morning) to the shoulder and upper arms. If serum testosterone concentrations are less than the normal range, dosage may be increased from 50 mg to 100 mg once daily; maximum daily dose: 100 mg/day.

Vogelxo: 50 mg applied once daily to the shoulder and/or upper arms. Dosage may be increased up to a maximum daily dose: 100 mg/day. Dose adjustment based on serum testosterone levels: If level less than normal range: Increase dose from 50 mg to 100 mg once daily.

Solution: Axiron: 60 mg once daily; dosage range: 30 to 120 mg/day. Apply to the axilla at the same time each morning; do not apply to other parts of the body. Dose adjustment based on serum testosterone levels:

>1,050 ng/dL: Decrease 60 mg/day dose to 30 mg/day; if levels >1,050 ng/dL persist after dose reduction discontinue therapy

<300 ng/dL: Increase 60 mg/day dose to 90 mg/day, or increase 90 mg/day dose to 120 mg/day

Transdermal system: Androderm:

Initial: 4 mg/day (as one 4 mg/day patch; do not use two 2 mg/day patches). Dose adjustment based on testosterone levels:

>930 ng/dL: Decrease dose to 2 mg/day

400 to 930 ng/dL: Continue 4 mg/day

<400 ng/dL: Increase dose to 6 mg/day (as one 4 mg/day and one 2 mg/day patch)

Dosing conversion of transdermal patches: If needed, patients may be switched from the 2.5 mg/day, 5 mg/day, and 7.5 mg/day patches as follows. Patch change should occur at their next scheduled dosing. Measure early morning testosterone concentrations ~2 weeks after switching therapy:

From 2.5 mg/day patch to 2 mg/day patch

From 5 mg/day patch to 4 mg/day patch

From 7.5 mg/day patch to 6 mg/day patch (one 2 mg/day and one 4 mg/day patch)

Intranasal: Testosterone gel: Natesto: 11 mg (2 pump actuations; 1 actuation per nostril) intranasally 3 times daily (6 to 8 hours apart). Total daily dose: 33 mg

Dose adjustment based on testosterone levels:

Less than normal range: Consider alternative treatment if consistently <300 ng/mL

Greater than normal range: Discontinue if consistently >1,050 ng/mL

Multiple pituitary hormone deficiency (with microphallus): Limited data available: Infants: IM: Enanthate or cypionate: 25 mg every 4 weeks for 3 months; may repeat for another second course if necessary (Kliegman 2016).

Dosing: Renal Impairment: Pediatric

All patients: There are no dosage adjustments provided in manufacturer’s labeling (has not been studied). Use with caution; may enhance edema formation. Testosterone cypionate is contraindicated in serious renal disease.

Dosing: Hepatic Impairment: Pediatric

All patients: There are no dosage adjustments provided in manufacturer’s labeling (has not been studied). Use with caution; may enhance edema formation. Testosterone cypionate is contraindicated in serious hepatic disease.

Use: Labeled Indications

Breast cancer, metastatic: IM injection (enanthate): Secondary treatment in women with advancing inoperable metastatic (skeletal) mammary cancer who are 1 to 5 years postmenopausal. Use may be considered in premenopausal women with breast cancer who have benefited from oophorectomy and have a hormone-responsive tumor.

Delayed puberty: IM injection (enanthate); pellet: To stimulate puberty in carefully selected males with delayed puberty.

Hypogonadism, hypogonadotropic (congenital or acquired): Buccal; Capsule (oral) [Canadian product]; Gel (nasal, transdermal); IM injection (cypionate, enanthate, undecanoate); Patch (transdermal); Pellet; Solution (transdermal); SubQ injection (enanthate): Gonadotropin or luteinizing hormone-releasing hormone deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Hypogonadism, primary (congenital or acquired): Buccal; Capsule (oral) [Canadian product]; Gel (nasal, transdermal); IM injection (cypionate, enanthate, undecanoate); Patch (transdermal); Pellet; Solution (transdermal); SubQ injection (enanthate): Treatment of testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.

Limitations of use: Safety and efficacy in men with age-related hypogonadism (or late-onset hypogonadism) has not been established (manufacturer’s labeling). However, the Endocrine Society recommends offering testosterone therapy to patients with symptoms of testosterone deficiency and consistently and unequivocally low morning testosterone concentrations. In men >65 years of age, treatment should only be initiated on an individual basis and after consultation with the patient regarding risks and benefits (Endocrine Society [Bhasin 2018]).

Use: Off-Label: Adult

  Hormone therapy for transgender males (female-to-male)Level of Evidence [G]

Based on the Endocrine Society guidelines for the endocrine treatment of gender dysphoric/gender incongruent persons, testosterone as monotherapy is effective for elevating serum testosterone levels into the normal range for males, resulting in cessation of menses, clitoromegaly, decreased fat mass and fertility (temporary or permanent), deepening of the voice, increased acne, body and facial hair, muscle mass and sexual desire, and male pattern baldness (in those genetically predisposed) Ref.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Androgen therapy in women:

Endocrine Society Clinical Practice Guideline, “Androgen Therapy in Women,” 2014

Drug-Induced Liver Injury:

American College of Gastroenterology (ACG), “2014 ACG Guideline for Idiosyncratic Drug-induced Liver Injury,” July 2014

Hormone therapy for transgender males:

Endocrine Society, “Endocrine treatment of gender-dysphoric/gender-incongruent persons: An Endocrine Society clinical practice guideline,” December 2017

The World Professional Association for Transgender Health, “Standards of care for the health of transsexual, transgender and gender nonconforming people, Version 7,” 2011

Hypogonadism:

“AACE Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hypogonadism in Adult Male Patients: 2002 Update,” November/December 2002

American Urological Association Guideline, “Evaluation and Management of Testosterone Deficiency,” March 2018

Endocrine Society Clinical Practice Guideline, “Testosterone Therapy in Men With Hypogonadism,” March 2018

Hypopituitarism:

Endocrine Society, “Hormonal Replacement in Hypopituitarism in Adults,” 2016

Administration: IM

IM: Administer by deep IM injection into the gluteal muscle.

Testosterone undecanoate: Inject into the gluteus medius; alternate injection between left and right buttock. Avoid intravascular injection, may lead to pulmonary oil microembolism; avoid the superior gluteal arteries and sciatic nerve.

Administration: Oral

Oral, buccal application (Striant): One mucoadhesive for buccal application (buccal system) should be applied to a comfortable area above the incisor tooth twice daily. Gently push the curved side against the upper gum. Hold buccal system firmly in place by pushing down on outside of the upper lip for 30 seconds to ensure adhesion. The buccal system should adhere to gum until it is removed. Rotate to alternate sides of mouth with each application. If the buccal system falls out, replace with a new system. If the system falls out within the first 8 hours of dosing, replace with a new buccal system and continue for a total of 12 hours from the placement of the first system. If the system falls out of position after 8 hours of dosing, a new buccal system should be applied and it may remain in place for 12 hours, then continue with the next regularly scheduled dosing. System will soften and mold to shape of gum as it absorbs moisture from mouth. Do not chew or swallow the buccal system. The buccal system will not dissolve; gently remove by sliding downwards from gum; avoid scratching gum. Remove prior to routine morning and evening oral care, prior to application of new system.

Oral, capsule (Andriol [Canadian product]): Administer with meals. Should be swallowed whole; do not crush or chew.

Administration: Topical

Topical gel and solution: General information: Alcohol-based gels and solutions are flammable; avoid fire, flames, or smoking until dry. Testosterone may be transferred to another person following skin-to-skin contact with the application site. Strict adherence to application instructions is needed in order to decrease secondary exposure. Thoroughly wash hands after application and cover application site with clothing (ie, shirt) once gel or solution has dried, or clean application site thoroughly with soap and water prior to contact in order to minimize transfer. In addition to skin-to-skin contact, secondary exposure has also been reported following exposure to secondary items (eg, towel, shirt, sheets). If secondary exposure occurs, the other person should thoroughly wash the skin with soap and water as soon as possible. The application sites and doses of topical testosterone products are not interchangeable.

Product-specific administration instructions:

AndroGel 1%: Apply at the same time each morning to clean, dry, intact skin to an area of the shoulder, upper arms, and/or abdomen that will be covered by a short sleeve t-shirt. Do not apply to other parts of the body such as the genitals, chest, back, axillae, or knees. Upon opening the packet(s), the entire contents should be squeezed into the palm of the hand and immediately applied to the application site(s). Alternatively, a portion may be squeezed onto palm of hand and applied, repeating the process at the same or other site until entire packet has been applied. Avoid swimming, showering or washing the application site for ≥5 hours following application. Cover application site with clothing (eg t-shirt) once the gel has dried. When using the multidose pump, prime pump 3 times (and discard this portion of product) prior to initial use. Each actuation delivers 12.5 mg of testosterone (4 actuations = 50 mg; 6 actuations = 75 mg; 8 actuations=100 mg). When using the pump, the gel may be delivered into the palm of the hand prior to application or applied directly to the application site.

AndroGel 1.62%: Apply at the same time each morning to clean, dry, intact skin to an area of the shoulder and upper arms that will be covered by a short sleeve t-shirt. Do not apply to other parts of the body such as the abdomen, genitals, chest, axillae, or knees. Upon opening the packet(s), the entire contents should be squeezed into the palm of the hand and immediately applied to the application site(s). Alternatively, a portion may be squeezed onto palm of hand and applied, repeating the process at the same or other site until entire packet has been applied. Avoid swimming, showering or washing the application site for ≥2 hours following application. Cover application site with clothing (eg t-shirt) once the gel has dried. When using the multidose pump, prime pump 3 times (and discard this portion of product) prior to initial use. Each actuation delivers 20.25 mg of testosterone (2 actuations = 40.5 mg; 3 actuations = 60.75 mg; 4 actuations = 81 mg). When using the pump, the gel may be delivered into the palm of the hand prior to application or applied directly to the application site.

Axiron: Apply using the applicator to clean, dry, intact skin on an area of the axilla at the same time each morning. Do not apply to other parts of the body (eg, abdomen, genitals, shoulders, upper arms). Avoid washing the site or swimming for 2 hours after application. Prior to first use, prime the applicator pump by depressing it 3 times (discard this portion of the product). After priming, position the nozzle over the applicator cup and depress pump fully one time; ensure liquid enters cup. Each pump actuation delivers testosterone 30 mg. No more than 30 mg (one pump) should be added to the cup at one time. The total dose should be divided between axilla (example, 30 mg/day: apply to one axilla only; 60 mg/day: apply 30 mg to each axilla; 90 mg/day: apply 30 mg to each axilla, allow to dry, then apply an additional 30 mg to one axilla; etc). To apply dose, keep applicator upright and wipe into the axilla; if solution runs or drips, use cup to wipe. Do not rub into skin with fingers or hand. If more than one 30 mg dose is needed, repeat process. Apply roll-on or stick antiperspirants or deodorants prior to testosterone. Once application site is dry, cover with clothing. After use, rinse applicator under running water and pat dry with a tissue.

Fortesta: Apply to clean dry intact skin once daily in the morning to skin of front and inner thighs. Do not apply to genitals or other parts of the body. Use one finger to rub gel evenly onto skin of each thigh. Avoid showering, washing the site, or swimming for ≥2 hours after application. Prior to first dose, prime the pump by holding canister upright and fully depressing the pump 8 times (discard this portion of the product). Each pump actuation delivers testosterone 10 mg. The total dose should be divided between thighs (example, 10 mg/day: apply 10 mg to one thigh only; 20 mg/day: apply 10 mg to each thigh; 30 mg/day: apply 20 mg to one thigh and 10 mg to the other thigh; etc). Once application site is dry, cover with clothing.

Testim: Apply once daily (preferably in the morning) to clean, dry, intact skin to an area of the shoulder and upper arms that will be covered by a short sleeve t-shirt. Do not apply to the genitals or abdomen. Upon opening the tube, the entire contents should be squeezed into the palm of the hand and immediately applied to the application site(s). Avoid swimming, showering or washing the application site for ≥2 hours following application. Cover application site with clothing (eg t-shirt) once the gel has dried.

Vogelxo: Apply once daily at the same time each morning to clean dry intact skin to an area of the shoulder and upper arms that will be covered by a short sleeve t-shirt. Do not apply to the genitals or to the abdomen. Upon opening the tube or packet, the entire contents should be squeezed into the palm of the hand and immediately applied to the application site(s). If two doses (testosterone 100 mg) are needed, apply one dose (50 mg) to upper arm and or/shoulder, then apply the second dose (50 mg) to the opposite upper arm and/or shoulder. Avoid showering, washing the site, or swimming for at least 2 hours following application. Cover application site with clothing (eg t-shirt) once the gel has dried. When using the multidose pump, prime pump 3 times by fully depressing the pump mechanism (actuation) and discard this portion of product. Each actuation delivers testosterone 12.5 mg (4 actuations = 50 mg; 8 actuations = 100 mg).

Transdermal patch (Androderm): Apply to skin immediately upon removal from the protective pouch. Apply at the same time each night to clean, dry area of skin on the back, abdomen, upper arms, or thigh. Do not apply to bony areas or parts of the body that are subject to prolonged pressure while sleeping or sitting. Do not apply to oily, damaged, or irritated skin. Do not apply to the scrotum. Rotate administration sites, allowing 7 days between applying to the same site. Avoid showering, washing the site, or swimming for ≥3 hours after application. Following patch removal, mild skin irritation may be treated with OTC hydrocortisone cream. A small amount of triamcinolone acetonide 0.1% cream may be applied under the system to decrease irritation; do not use ointment (triamcinolone ointment decreases testosterone absorption). Dispose of any used or unused patches by folding adhesive ends together, replace in pouch or sealed container, and discard properly in trash away from children and pets.

Administration: Subcutaneous

Subcutaneous implant (Testopel): Using strict sterile technique, must be surgically implanted.

Subcutaneous injection (Xyosted): Administer in the abdominal region only. Do not administer IM or IV.

Administration: Intranasal

Intranasal gel (Natesto): Administer intranasally 3 times daily, 6 to 8 hours apart, preferably at the same time each day. Prime pump prior to first use by inverting then depressing pump 10 times (discard this portion of product into sink). Blow nose prior to application. To administer the dose, insert actuator into nostril until pump reaches base of nose; tilt so the tip is in contact with the lateral wall of nostril. Depress slowly until pump stops, then remove from nose while wiping tip to transfer gel to lateral side of nostril. Following administration, press on the nostrils at a point just below the bridge of the nose and lightly massage. Refrain from blowing nose or sniffing for 1 hour after administration. If gel gets on hands, wash with warm soap and water. Temporarily discontinue with episodes of severe rhinitis; if severe rhinitis symptoms persist consider an alternative therapy.

Administration: Pediatric

Parenteral:

IM:

Cypionate, enanthate: Warming injection to room temperature and shaking vial will help redissolve crystals that have formed after storage. Administer by deep IM injection into the gluteal muscle.

Undecanoate: Inject into the gluteus medius; alternate injection between left and right buttock. Avoid intravascular injection, may lead to pulmonary oil microembolism; avoid the superior gluteal arteries and sciatic nerve.

Subcutaneous implant (Testopel): Using strict sterile technique, must be surgically implanted.

Topical:

Buccal: Striant: One mucoadhesive for buccal application (buccal system) should be applied to a comfortable area above the incisor tooth. Apply flat side of system on fingertip. Gently push the curved side against upper gum. Rotate to alternate sides of mouth with each application. Hold buccal system firmly in place for 30 seconds to ensure adhesion. The buccal system should adhere to gum for 12 hours. If the buccal system falls out with the first 8 hours of dosing, replace with a new system and continue for a total of 12 hours from the placement of the first system. If the system falls out of position after 8 hours of dosing, a new buccal system should be placed and remain for 12 hours, then continue with the next regularly scheduled dose. System will soften and mold to shape of gum as it absorbs moisture from mouth. Do not chew or swallow the buccal system; check to ensure buccal system is in place following toothbrushing, use of mouthwash, and consumption of food or beverages. The buccal system will not dissolve; gently remove by sliding downwards from gum; avoid scratching gum.

Dermal:

Gels and solution: Apply to clean, dry, intact skin. Application sites should be allowed to dry for a few minutes prior to dressing. Hands should be washed with soap and water after application. Do not apply testosterone gel or solution to the genitals. Alcohol-based gels and solutions are flammable; avoid fire or smoking until dry. Testosterone may be transferred to another person following skin-to-skin contact with the application site. Strict adherence to application instructions is needed in order to decrease secondary exposure. Thoroughly wash hands after application and cover application site with clothing (ie, shirt).

AndroGel 1%: Apply at the same time each morning to clean, dry, intact skin to an area of the shoulder, upper arms, and/or abdomen that will be covered by a short sleeve t-shirt. Do not apply to other parts of the body such as the genitals, chest, back, axillae, or knees. Upon opening the packet(s), the entire contents should be squeezed into the palm of the hand and immediately applied to the application site(s). Alternatively, a portion may be squeezed onto palm of hand and applied, repeating the process at the same or other site until entire packet has been applied. Avoid swimming, showering, or washing the application site for ≥5 hours following application. Cover application site with clothing (eg, t-shirt) once the gel has dried. When using the multidose pump, prime pump 3 times (and discard this portion of product) prior to initial use. Each actuation delivers 12.5 mg of testosterone (4 actuations = 50 mg; 6 actuations = 75 mg; 8 actuations = 100 mg). When using the pump, the gel may be delivered into the palm of the hand prior to application or applied directly to the application site.

AndroGel 1.62%: Apply at the same time each morning to clean, dry, intact skin to an area of the shoulder and upper arms that will be covered by a short sleeve t-shirt. Do not apply to other parts of the body such as the abdomen, genitals, chest, axillae, or knees. Upon opening the packet(s), the entire contents should be squeezed into the palm of the hand and immediately applied to the application site(s). Alternatively, a portion may be squeezed onto palm of hand and applied, repeating the process at the same or other site until entire packet has been applied. Avoid swimming, showering, or washing the application site for ≥2 hours following application. Cover application site with clothing (eg, t-shirt) once the gel has dried. When using the multidose pump, prime pump 3 times (and discard this portion of product) prior to initial use. Each actuation delivers 20.25 mg of testosterone (2 actuations = 40.5 mg; 3 actuations = 60.75 mg; 4 actuations = 81 mg). When using the pump, the gel may be delivered into the palm of the hand prior to application or applied directly to the application site.

Axiron: Apply using the applicator to clean, dry, intact skin on the axilla at the same time each morning. Do not apply to other parts of the body (eg, abdomen, genitals, shoulders, upper arms). Avoid washing the site or swimming for 2 hours after application. Prior to first use, prime the applicator pump by depressing it 3 times (discard this portion of the product). After priming, position the nozzle over the applicator cup and depress pump fully one time; ensure liquid enters cup. Each pump actuation delivers testosterone 30 mg. No more than 30 mg (one pump) should be added to the cup at one time. The total dose should be divided between axilla (eg, 30 mg/day: Apply to one axilla only; 60 mg/day: Apply 30 mg to each axilla; 90 mg/day: Apply 30 mg to each axilla, allow to dry, then apply an additional 30 mg to one axilla; etc). To apply dose, keep applicator upright and wipe into the axilla; if solution runs or drips, use cup to wipe. Do not rub into skin with fingers or hand. If more than one 30 mg dose is needed, repeat process. Apply roll-on or stick antiperspirants or deodorants prior to testosterone. Once application site is dry, cover with clothing. After use, rinse applicator under running water and pat dry with a tissue. The application site and dose of this product are not interchangeable with other topical testosterone products.

Fortesta: Apply to clean, dry, intact skin of front and inner thighs. Do not apply to other parts of the body. Use one finger to rub gel evenly onto skin of each thigh. Avoid showering, washing the site, or swimming for ≥2 hours after application. Prior to first dose, prime the pump by holding canister upright and fully depressing the pump 8 times (discard this portion of the product). Each pump actuation delivers testosterone 10 mg. The total dose should be divided between thighs (eg, 10 mg/day: Apply 10 mg to one thigh only; 20 mg/day: Apply 10 mg to each thigh; 30 mg/day: Apply 20 mg to one thigh and 10 mg to the other thigh; etc). Once application site is dry, cover with clothing. The application site and dose of this product are not interchangeable with other topical testosterone products.

Testim: Apply once daily (preferably in the morning) to clean, dry, intact skin to an area of the shoulder and upper arms that will be covered by a short sleeve t-shirt. Do not apply to the genitals or abdomen. Upon opening the tube, the entire contents should be squeezed into the palm of the hand and immediately applied to the application site(s). Avoid swimming, showering, or washing the application site for ≥2 hours following application. Cover application site with clothing (eg, t-shirt) once the gel has dried.

Vogelxo: Apply once daily at the same time each morning to clean, dry, intact skin to an area of the shoulder and upper arms that will be covered by a short sleeve t-shirt. Do not apply to the genitals or to the abdomen. Upon opening the tube or packet, the entire contents should be squeezed into the palm of the hand and immediately applied to the application site(s). If two doses (testosterone 100 mg) are needed, apply one dose (50 mg) to upper arm and or/shoulder, then apply the second dose (50 mg) to the opposite upper arm and/or shoulder. Avoid showering, washing the site, or swimming for at least 2 hours following application. Cover application site with clothing (eg, t-shirt) once the gel has dried. When using the multidose pump, prime pump 3 times by fully depressing the pump mechanism (actuation) and discard this portion of product. Each actuation delivers testosterone 12.5 mg (4 actuations = 50 mg; 8 actuations = 100 mg).

Transdermal patch: Androderm: Apply to skin immediately upon removal from the protective pouch. Apply at the same time each night to clean, dry area of skin on the back, abdomen, upper arms, or thigh. Do not apply to bony areas or parts of the body that are subject to prolonged pressure while sleeping or sitting. Do not apply to oily, damaged, or irritated skin. Do not apply to the scrotum. Rotate administration sites, allowing 7 days between applying to the same site. Avoid showering, washing the site, or swimming for ≥3 hours after application. Following patch removal, mild skin irritation may be treated with OTC hydrocortisone cream. A small amount of triamcinolone acetonide 0.1% cream may be applied under the system to decrease irritation; do not use ointment (triamcinolone ointment decreases testosterone absorption). Dispose of any used or unused patches by folding adhesive ends together, replace in pouch or sealed container and discard properly in trash away from children and pets.

Intranasal: Intranasal gel (Natesto): Administer intranasally 3 times daily, 6 to 8 hours apart, preferably at the same time each day. Prime pump prior to first use by inverting then depressing pump 10 times (discard this portion of product into sink). Blow nose prior to application. To administer the dose, insert actuator into nostril until pump reaches base of nose; tilt so the tip is in contact with the lateral wall of nostril. Depress slowly until pump stops, then remove from nose while wiping tip to transfer gel to lateral side of nostril. Following administration, press on the nostrils at a point just below the bridge of the nose and lightly massage. Refrain from blowing nose or sniffing for 1 hour after administration. If gel gets on hands, wash with warm soap and water. Temporarily discontinue with episodes of severe rhinitis; if severe rhinitis symptoms persist, consider an alternative therapy.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 3]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage.

For IM preparation, double gloves, a protective gown, and ventilated engineering controls (a class II biological safety cabinet or a compounding aseptic containment isolator) are recommended. Double gloving and a protective gown are required during IM administration. NIOSH recommends double gloving, a protective gown, and (if liquid that could splash) eye/face protection for administration of a topical product; if there is potential for inhalation, respiratory protection is recommended (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).

Storage/Stability

Andriol [Canadian product]: Store between 15°C and 30°C; protect from light and moisture; keep blister packs in outer carton; do not refrigerate.

Androderm: Store at 20°C to 25°C (68°F to 77°F). Do not store outside of pouch. Excessive heat may cause system to burst.

AndroGel 1%, Axiron, Aveed: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Store Aveed in original container.

AndroGel 1.62%, Fortesta, Natesto, Testim, Vogelxo: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Do not freeze.

Depo-Testosterone: Store at 20°C to 25°C (68°F to 77°F). Protect from light.

Striant: Store at 20°C to 25°C (68°F to 77°F). Protect from heat and moisture.

Testopel: Store in a cool location.

Testosterone enanthate injection:

IM injection: Store at room temperature.

SubQ injection: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Do not refrigerate or freeze. Protect from light; keep in original carton.

Preparation for Administration: Adult

Injection:

Testosterone enanthate (IM injection), testosterone cypionate: Warm and rotate vial between palms of hands to redissolve crystals that have formed after storage.

Testosterone undecanoate: Inject 3 mL of air through the gray rubber stopper into the vial to create positive pressure, and then withdraw 3 mL of solution (750 mg) from the vial. Expel any air bubbles from the syringe and change the syringe needle to a new IM needle. Discard unused portion.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience acne, diarrhea, emotional instability, loss of strength and energy, insomnia, pharyngitis, change in taste, bad taste, back pain. Have patient report immediately to prescriber signs of high calcium (weakness, confusion, fatigue, headache, nausea and vomiting, constipation, or bone pain), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of blood clots (numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; angina; shortness of breath; tachycardia; or coughing up blood), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), angina, cough, sweating a lot, throat tightness, severe headache, dizziness, passing out, vision changes, priapism, polyuria, urinary retention, change in amount of urine passed, urinary incontinence, depression, mood changes, behavioral changes, suicidal ideation, enlarged breasts, breast pain, shortness of breath, excessive weight gain, swelling of arms or legs, nausea, vomiting, difficulty breathing during sleep, day fatigue, skin discoloration, testicle irregularities, severe application site irritation, nosebleed, nasal dryness, rhinitis, rhinorrhea, nasal scabs, sneezing, gingival changes, or signs of virilization (in females a deep voice, facial hair, acne, or menstrual changes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Geriatric Patients: High-Risk Medication:
  Other safety concerns:
REMS Components

AndroGel 1%, AndroGel 1.62%, Axiron, Fortesta, Testim, testosterone gel, testosterone topical solution, Vogelxo: Medication Guide

Aveed: Elements to Assure Safe Use; Implementation System

Contraindications

Breast cancer (males); prostate cancer (known or suspected); pregnancy

Androderm, Axiron, Fortesta, Natesto, Striant, Testim, Vogelxo: Additional contraindication: Breastfeeding women; women who may become pregnant

Andriol [Canadian product]: Additional contraindications: Hypersensitivity to any component of the formulation; use in women

Aveed: Additional contraindications: Hypersensitivity to testosterone undecanoate, castor oil, benzyl benzoate; breastfeeding women; women who may become pregnant

Depo-Testosterone: Additional contraindications: Hypersensitivity to testosterone cypionate, serious cardiac, hepatic, or renal disease

Testosterone enanthate (IM injection): Additional contraindications: Hypersensitivity to any component of the formulation; women who may become pregnant

Testosterone enanthate (SubQ injection): Additional contraindications: Hypersensitivity to any component of the formulation; men with hypogonadal conditions that are not associated with structural or genetic etiologies (eg, age-related hypogonadism); women who may become pregnant

Canadian labeling: Additional contraindication (not in the US labeling): Androderm: Hypersensitivity to any component of the formulation; skin contact in pregnant or breastfeeding women; not indicated for use in women

Documentation of allergenic cross-reactivity for androgens is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Blood pressure increases: [US Boxed Warning]: Subcutaneous testosterone enanthate can increase blood pressure (BP). Increased BP has been reported with other testosterone products as well. Check BP prior to initiation of therapy, at approximately 6 weeks and periodically thereafter. Some patients may require initiation or adjustment of antihypertensive therapy.

• Breast cancer: Long term use (>10 years) of parenteral testosterone for male hypogonadism may increase the risk of breast cancer (Medras 2006).

• Cardiovascular events: Available studies are inconclusive regarding the risk of developing major adverse cardiovascular events (MACE) such as nonfatal MI, stroke, or cardiovascular death following testosterone use. Some studies have suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy (Basaria 2010; Finkle 2014; Vigen 2013), although the overall evidence does not demonstrate an increased or decreased cardiovascular risk (Endocrine Society [Bhasin 2018]; Corona 2014; Morgentaler 2015). According to the FDA, prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions (eg, disorders of the testicles, pituitary gland, brain) and confirmed by laboratory tests (FDA Drug Safety Communication 2015). However, in a position statement issued by the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE), they recommend that after a thorough diagnostic work-up, testosterone replacement should be guided by signs and symptoms and testosterone concentrations rather than the underlying cause (AACE/ACE [Goodman 2015]). The Endocrine Society recommends avoiding testosterone therapy in men who have experienced an MI or stroke within the past six months (Endocrine Society [Bhasin 2018]). Evaluate patients for cardiovascular risk factors prior to initiating therapy and monitor closely during therapy for cardiovascular events.

• Dyslipidemia: May alter serum lipid profile; use caution with history of MI or coronary artery disease.

• Gynecomastia: May cause gynecomastia, which may persist in patients treated for hypogonadism.

• Hepatic effects: Prolonged use of high doses of androgens has been associated with serious hepatic effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, jaundice). Prolonged use of intramuscular testosterone enanthate has been associated with multiple hepatic adenomas. Discontinue therapy if signs or symptoms of hepatic dysfunction (such as jaundice) develop.

• Hypercalcemia: May cause hypercalcemia in patients with prolonged immobilization or cancer.

• Oligospermia: Large doses may suppress spermatogenesis; oligospermia may occur. Discontinue therapy if this occurs, if restarted, a lower dose should be used.

• Polycythemia: May increase hematocrit requiring dose adjustment or discontinuation. Withhold initial treatment in patients with hematocrit >48% or >50% if living at higher altitudes. Discontinue therapy if hematocrit exceeds 54%; may reinitiate at lower dose (Endocrine Society [Bhasin 2018]).

• Priapism: Priapism or excessive sexual stimulation may occur; discontinue therapy if this occurs, if restarted, a lower dose should be used.

• Prostate cancer: May increase the risk of prostate cancer. Withhold therapy pending urological evaluation in patients with palpable prostate nodule or induration, PSA >4 ng/mL, or PSA >3 ng/mL in men at high risk of prostate cancer (Endocrine Society [Bhasin 2018]).

• Venous thromboembolism: Venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported with testosterone products. Evaluate patients with symptoms of pain, edema, warmth, and erythema in the lower extremity for DVT and those with acute shortness of breath for PE. Discontinue therapy if a venous thromboembolism is suspected. Use in hypogonadal men with thrombophilia is not recommended (Endocrine Society [Bhasin 2018]).

Disease-related concerns:

• Benign prostatic hyperplasia (BPH): Androgens may worsen BPH; use in patients with severe lower urinary tract symptoms ([AUA]/International Prostate Symptom Score [IPSS] >19) is not recommended (Endocrine Society [Bhasin 2018]). Discontinue therapy if urethral obstruction develops in patients with BPH (use lower dose if restarted).

• Depression: Use with caution in patients with depression; testosterone may increase risk of depression and suicidal ideation. Evaluate patients with new onset or worsening depression, anxiety, mood changes, or suicidal ideation or behavior.

• Diseases exacerbated by fluid retention: Use with caution in patients with diseases that may be exacerbated by fluid retention, including cardiac impairment; testosterone may cause fluid retention. Treatment of androgen deficiency syndromes is not recommended for men with uncontrolled or poorly controlled heart failure (Endocrine Society [Bhasin 2018]).

• Hepatic impairment: Use with caution in patients with hepatic impairment; testosterone may cause fluid retention; testosterone cypionate is contraindicated in serious hepatic impairment.

• Renal impairment: Use with caution in patients with renal impairment; testosterone may cause fluid retention; testosterone cypionate is contraindicated in serious renal impairment.

• Sleep apnea: May potentiate sleep apnea in some male patients, especially those with risk factors (eg, obesity or chronic lung disease). Withhold initial treatment in patients with untreated obstructive sleep apnea (Endocrine Society [Bhasin 2018]).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Geriatric patients may be at greater risk for prostatic hyperplasia, prostate cancer, fluid retention, and transaminase elevations. Testosterone replacement in patients >65 years of age is not routinely recommended and should only be considered on a case by case basis if conditions or symptoms suggestive of low testosterone are present along with consistently and unequivocally low morning testosterone concentrations (Endocrine Society [Bhasin 2018]).

• Pediatric: May accelerate bone maturation (without producing compensatory gain in linear growth) and premature closure of the epiphyses in children; in prepubertal children perform radiographic examination of the hand and wrist every 6 months to determine the rate of bone maturation and to assess the effect of treatment on the epiphyseal centers. Use with caution in males with delayed puberty.

• Women: During treatment for metastatic breast cancer, women should be monitored for signs of virilization; discontinue if mild virilization is present to prevent irreversible symptoms.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [“Inactive” 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Castor oil: Some products may contain castor oil.

• Gel, intranasal: Use of the intranasal gel is not recommended in patients with sinus disease, mucosal inflammatory disorders (eg, Sjogren syndrome), or with a history of nasal disorders, nasal or sinus surgery, nasal fracture within the previous 6 months, or nasal fracture that caused a deviated anterior nasal septum. Safety and efficacy have not been established in males with a BMI >35 kg/m2.

• Gel, topical: Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure; these products are not interchangeable.

• Injection: Testosterone cypionate should not be used interchangeably with testosterone propionate due to differences in duration of action.

• Pellet: Pellet insertion has been associated with infection and/or pellet extrusion at or around the implantation site, occurring concurrently or separately. Most reported cases occurred <1 month after implantation. Symptoms may include induration, inflammation, fibrosis, bleeding, bruising, drainage, pain, itching, and pellet extrusion; further treatment may be warranted if infection or extrusion occurs.

• Pulmonary oil microembolism: Testosterone undecanoate injection: [US Boxed Warning]: Serious pulmonary oil microembolism (POME) reactions and anaphylaxis have been reported with testosterone undecanoate injection. Reactions include anaphylaxis, chest pain, urge to cough, dizziness, dyspnea, throat tightening, and syncope; may be life threatening. Reactions may occur after any injection during the course of therapy, including the first dose. Patients must be monitored for 30 minutes after injection. Due to the risk of serious POME reactions, Aveed is only available through the Aveed REMS program. To minimize risk of adverse reactions, inject deeply into gluteal muscle. Rare reports of reactions involving urge to cough, coughing fits, and respiratory distress immediately after the intramuscular injection of testosterone enanthate (an oil-based depot preparation) have also been reported.

• Sesame oil: Some products may contain sesame oil.

• Solution: Axiron is not interchangeable with other topical testosterone products. Use in males with BMI >35 kg/m2 has not been established.

• Transdermal patch: May contain conducting metal (eg, aluminum); remove patch prior to MRI.

Other warnings/precautions:

• Abuse/misuse/diversion: Anabolic steroids may be abused, typically at doses higher than recommended and in combination with other anabolic androgenic steroids; abuse may be associated with serious cardiovascular and psychiatric adverse reactions. Inform patients of the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids; if abuse is suspected, check serum testosterone levels (testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives). Consider the possibility of abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.

• Dependence: Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented; however dependence may occur when used outside of approved dosage/indications.

• Secondary exposure: Testosterone may be transferred to another person following skin-to-skin contact with the application site. [US Boxed Warning]: Virilization in children has been reported following contact with unwashed or unclothed application sites of men using topical testosterone. Patients should strictly adhere to instructions for use in order to prevent secondary exposure. Children and women should avoid contact with application sites of men using topical products. Symptoms of virilization generally regress following removal of exposure; however, in some children, enlarged genitalia and bone age did not fully return to age appropriate normal. Signs of inappropriate virilization in women or children following secondary exposure to topical testosterone should be brought to the attention of a healthcare provider.

Geriatric Considerations

Elderly males treated with androgens may be at increased risk of developing prostatic hyperplasia and prostatic carcinoma. Increase in libido may occur.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).

Pregnancy Risk Factor

X

Pregnancy Considerations

Use is contraindicated during pregnancy. Exposure to a fetus may cause virilization of varying degrees. Because of the potential for secondary exposure, all children and women should avoid skin-to-skin contact to areas where testosterone has been applied topically on another person.

Some products contain benzyl alcohol, which can cross the placenta.

Use may be contraindicated in persons who may become pregnant. Large doses of testosterone may suppress spermatogenesis. Treatment of hypogonadotropic hypogonadism is not recommended for men desiring fertility (Endocrine Society [Bhasin 2018]).

Breast-Feeding Considerations

Testosterone is present in breast milk. Most products are contraindicated while breastfeeding.

Distribution of testosterone in breast milk was evaluated following use of the subcutaneous pellet in a breastfeeding woman. Prior to therapy, milk concentrations of testosterone were 96 pg/mL. Following SubQ implantation of the 100 mg pellet, milk samples ranged from 88 pg/mL (day 2) to 100 pg/mL (day 7 [morning]). Reported maternal serum samples ranged from <100 pg/mL (baseline), 2830 pg/mL (day 2), and 1,480 pg/mL (day 7 [morning]). Adverse events were not observed in the breastfeeding male infant after 7 months of continuous maternal therapy (Glaser 2009).

Because of the potential for secondary exposure, all children and women should avoid skin-to-skin contact to areas where testosterone has been applied topically on another person.

High levels of endogenous maternal testosterone, such as those caused by certain ovarian cysts, suppress milk production. Maternal serum testosterone levels generally fall following pregnancy and return to normal once breastfeeding is stopped (Betzold 2004; Hoover 2002).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

>10%:

Dermatologic: Skin blister (application site; transdermal: 12%)

Genitourinary: Prostate specific antigen increase (≤6%; topical: ≤18%; buccal: 2%), benign prostatic hypertrophy (12%)

Local: Application-site pruritus (transdermal: 17% to 37%)

1% to 10%:

Cardiovascular: Hypertension (≤3%; buccal: ≤8%; intranasal: >6%), peripheral vascular disease (transdermal: <3%)

Central nervous system: Emotional lability (buccal: ≤8%; intramuscular, topical: ≤3%), anosmia (intranasal: 6%; buccal: 1%), altered sense of smell (intranasal: 5% to >6%; topical: 1%), headache (≤4%), procedural pain (intramuscular, intranasal: 4%), depression (≤3%), nervousness (≤3%), abnormality in thinking (transdermal: <3%), anxiety (<3%), body pain (transdermal: <3%), chills (transdermal: <3%), confusion (transdermal: <3%), fatigue (<3%), paresthesia (<3%), vertigo (transdermal: <3%), irritability (intramuscular: 2%), insomnia (intramuscular, topical: 1% to 2%), aggressive behavior (buccal, intramuscular: 1%), stinging sensation (lips; buccal: 1%)

Dermatologic: Acne vulgaris (≤8%), crusted skin (nasal scab; intranasal: 4% to 6%), excoriation (nasal; intranasal: ≤6%), contact dermatitis (topical, transdermal: 2% to 4%), bulla (application site; transdermal: <3%), skin rash (<3%), pruritus (≤2%), xeroderma (topical: ≤2%), erythema (topical: ≥1%), hyperhidrosis (intramuscular: 1%), alopecia (topical: ≤1%)

Endocrine & metabolic: Decreased HDL cholesterol (topical: ≤6%), hyperlipidemia (≤6%), hypokalemia (topical: ≤6%), increased serum triglycerides (≤6%), increased thyroid stimulating hormone level (intranasal: ≤6%), increased plasma estradiol concentration (intramuscular: 3%), decreased libido (≤3%), gynecomastia (≤3%), hot flash (intramuscular, topical: 1%), weight gain (intramuscular: 1%)

Gastrointestinal: Gingivitis (buccal: ≤9%), mouth irritation (buccal: ≤9%), decreased appetite (intranasal: ≤6%), nausea (≤6%), diarrhea (≤4%), gingival pain (buccal: 3%; includes gingival tenderness), dysgeusia (<3%), gastroesophageal reflux disease (transdermal: <3%), gastrointestinal hemorrhage (transdermal: <3%), increased appetite (topical, transdermal: <3%), gingival swelling (buccal: 2%), toothache (buccal: ≤1%), oral mucosa changes (buccal; includes buccal mucosa roughening and gum blister)

Genitourinary: Testicular atrophy (intranasal, topical: ≤6%), prostatic disease (topical, transdermal: 3% to 5%), hypogonadism (intramuscular: 3%), mastalgia (topical: ≤3%; buccal: 1%), prostatitis (transdermal: ≤3%), dysuria (intramuscular, transdermal: <3%), hematuria (transdermal: <3%), impotence (transdermal: <3%), pelvic pain (transdermal: <3%), urinary incontinence (transdermal: <3%), urinary tract infection (transdermal: <3%), testicular disease (including testicular tenderness and non-palpable testes: topical: 2%), urinary frequency (topical: ≤2%), breast hypertrophy (buccal: 1%), difficulty in micturition (buccal, topical: 1%), ejaculatory disorder (intramuscular: 1%), prostate induration (intramuscular: 1%), spontaneous erections (topical: 1%)

Hepatic: Increased serum bilirubin (topical: ≤6%), abnormal hepatic function tests (1%)

Hematologic & oncologic: Increased hematocrit (topical: ≤6%; buccal, intramuscular: 1%), anemia (topical: 3%), polycythemia (≤3%), prostate carcinoma (topical, transdermal: <3%), increased hemoglobin (intramuscular, topical: ≤2%)

Local: Application site erythema (topical, transdermal: ≤7%), application site vesicles (transdermal: 6%), application site reaction (topical: ≤6%), pain at injection site (intramuscular: 5%), application site induration: transdermal: 3%), application site irritation (transdermal: <3%), application site rash (transdermal: <3%), local skin exfoliation (transdermal; application site: <3%), application site burning (topical, transdermal: 1% to 3%), application site edema (topical: ≥1%), erythema at injection site (intramuscular: 1%)

Neuromuscular & skeletal: Back pain (transdermal: 6%), myalgia (intramuscular, intranasal: ≤6%), limb pain (intranasal, topical: ≤4%), weakness (topical: ≤3%), abnormal bone growth (accelerated; transdermal: <3%), hemarthrosis (transdermal: <3%)

Renal: Increased serum creatinine (topical: ≤6%), polyuria (transdermal: <3%)

Respiratory: Nasopharyngitis (intranasal: 4% to 9%; topical: ≥1%), rhinorrhea (intranasal: 4% to 8%), epistaxis (intranasal: 4% to 7%), nasal discomfort (intranasal: 4% to 6%), bronchitis (intranasal: 4%), upper respiratory tract infection (intranasal: 4%), dry nose (intranasal: ≤4%), nasal congestion (intranasal: ≤4%), sinusitis (intramuscular, intranasal: ≤4%), cough (intramuscular, intranasal: <3%), nasal mucosa swelling (buccal: 1%)

Frequency not defined:

Cardiovascular: Exacerbation of hypertension (buccal)

Central nervous system: Hostility (topical)

Gastrointestinal: Abdominal pain (buccal), gum line erosion (buccal)

Hepatic: Hepatic adenoma (intramuscular; long-term testosterone enanthate therapy)

<1%, postmarketing, and/or case reports: Abscess at injection site, allergic dermatitis, altered hormone level (fluctuating testosterone levels), amnesia, anaphylactoid reaction, anaphylactic shock, anaphylaxis, androgenetic alopecia, angina pectoris, angioedema, asthma, azoospermia, bitter taste, breast induration, calcium retention, cardiac failure, cerebral infarction, cerebrovascular accident, cerebrovascular insufficiency, change in HDL, chest pain, cholestatic jaundice, chronic obstructive pulmonary disease, circulatory shock, clotting factors suppression (factors II, V, VII, X), coronary artery disease, coronary occlusion, decreased plasma testosterone, decreased thyroxine binding globulin, deep vein thrombosis, device expulsion (pellet extrusion), diabetes mellitus, diaphoresis, discomfort at injection site, dizziness, drug abuse, dyspnea, edema, electrolyte disturbance (calcium, nitrogen, phosphorus, potassium, sodium), erectile dysfunction, fluid retention, flu-like symptoms, frequent erections, genitourinary infection (prostate), gingival erythema, hair discoloration, hearing loss (sudden), hematoma at injection site, hepatic neoplasm, hepatocellular neoplasm, hepatotoxicity (idiosyncratic; Chalasani 2014), hirsutism, hyperchloremia, hypernatremia, hyperparathyroidism, hypersensitivity angiitis, hypersensitivity reaction, hyperventilation, increased gamma-glutamyl transferase, increased intraocular pressure, increased libido, increased serum ALT, increased serum AST, increased serum prolactin, increased serum transaminases, increased testosterone level, infection, injection site reaction, inorganic phosphate retention, irritation at injection site, Korsakoff psychosis (nonalcoholic), lip edema, localized infection (abscess, cellulitis), malaise, malignant neoplasm of prostate, migraine, musculoskeletal chest pain, musculoskeletal pain, myocardial infarction, nephrolithiasis, nipple tenderness (sensitivity), oligospermia (may occur at high dosages), oral inflammation, oral mucosa ulcer, orgasm disturbance (male), osteoporosis, papular rash, peliosis hepatitis, peripheral edema, pharyngeal edema, pharyngolaryngeal pain, pollakiuria, potassium retention, priapism, prolonged partial thromboplastin time, prolonged prothrombin time, prostatic intraepithelial neoplasia, pulmonary embolism (including pulmonary oil microembolism), renal colic, renal function abnormality, renal pain, respiratory distress, restlessness, reversible ischemic neurological deficit, rhinitis, sleep apnea, sleep disorder, snoring, sodium retention, spermatocele, syncope, stomatitis, systemic lupus erythematosus, tachycardia, testicular pain, thrombocytopenia, thromboembolism, thrombosis, tinnitus, transient ischemic attacks, upper abdominal pain, urination disorder, vasodilatation, venous insufficiency, venous thromboembolism, vitreous detachment, voice disorder, xerostomia

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP2B6 (minor), CYP2C19 (minor), CYP2C9 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Ajmaline: Androgens may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor therapy

Blood Glucose Lowering Agents: Androgens may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

C1 inhibitors: Androgens may enhance the thrombogenic effect of C1 inhibitors. Risk C: Monitor therapy

Corticosteroids (Systemic): May enhance the fluid-retaining effect of Androgens. Risk C: Monitor therapy

CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Risk D: Consider therapy modification

Dehydroepiandrosterone: May enhance the adverse/toxic effect of Testosterone. Risk X: Avoid combination

Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Risk D: Consider therapy modification

Test Interactions

May decrease thyroxine-binding globulin, resulting in decreased total T4 and increased resin uptake of T3 and T4; free thyroid hormone levels are not changed.

Monitoring Parameters

Prior to treatment initiation: Confirm hypogonadism by measuring serum total testosterone on at least 2 separate mornings following overnight fasting. Liver function tests, lipid panel, hemoglobin and hematocrit (withhold initial treatment with hematocrit >48% or >50% in males living at higher altitudes) (Endocrine Society [Bhasin 2018]). PSA and prostate exam in men 55 to 69 years of age or ≥40 years of age and at increased risk for prostate cancer (withhold treatment pending urological evaluation in patients with palpable prostate nodule or induration or PSA >4 ng/mL or if PSA >3 ng/mL in men at high risk of prostate cancer (Endocrine Society [Bhasin 2018]); blood pressure.

During treatment:

Blood pressure, liver function tests, lipid panel, hemoglobin and hematocrit (at 3 to 6 months, at 12 months, then annually); discontinue therapy if hematocrit exceeds 54% (Endocrine Society [Bhasin 2018]). Monitor urine and serum calcium and signs of virilization in women treated for breast cancer. Serum glucose (may be decreased by testosterone, monitor patients with diabetes). Evaluate males for response to treatment and adverse events 3 to 12 months after initiation and then annually; monitor for cardiovascular events closely during therapy.

Bone mineral density:

Prepubertal children: Radiologic examination of wrist and hand every 6 months.

Hypogonadal men with osteoporosis or low trauma fracture: Monitor after 1 to 2 years of therapy (Endocrine Society [Bhasin 2018]).

Prostate-specific antigen (PSA): In men 55 to 69 years of age or ≥40 years of age and at increased risk for prostate cancer, PSA and prostate exam at 3 to 12 months, then as recommended based on current prostate cancer screening guidelines. Withhold treatment pending urological evaluation if there is a confirmed increase in PSA of >1.4 ng/mL from baseline, a confirmed PSA >4.0 ng/mL, or prostatic abnormality or substantial worsening of LUTS (Endocrine Society [Bhasin 2018]).

Testosterone (free): Free testosterone should be measured in patients with conditions associated with increased or decreased SHBG, or in patients with total testosterone concentrations in the borderline zone around the lower limit of the normal range (eg 200 to 400 ng/dL) (Endocrine Society [Bhasin 2018]).

Testosterone (total):

General recommendations: 3 to 6 months after initiation (formulation-dependent), at 12 months, then every 6 to 12 months (AUA [Mulhall 2018]; Endocrine Society [Bhasin 2018]).

Formulation-specific monitoring:

Buccal: Striant: Examine application area of gums; total serum testosterone 4 to 12 weeks after initiating treatment, prior to morning dose. Discontinue therapy if the total serum testosterone is consistently outside of the normal range.

Injection:

Testosterone cypionate injection: Measure testosterone level midway between injections (Endocrine Society [Bhasin 2018]).

Testosterone enanthate IM injection: Measure testosterone level midway between injections (Endocrine Society [Bhasin 2018]).

Testosterone enanthate SubQ injection: Measure total testosterone trough levels after 6 weeks of dosing, after 6 weeks following a dose adjustment, and periodically during therapy. Trough concentrations should be measured 7 days after the most recent dose.

Testosterone undecanoate (Aveed): Monitor for 30 minutes after injection; appropriate treatment should be available in the event of a serious POME reaction or anaphylaxis. Measure testosterone level just prior to each subsequent injection and adjust dosing interval to maintain nadir levels in low-mid range (Endocrine Society [Bhasin 2018]). Alternatively, may measure halfway between each 10-week injection (AUA [Mulhall 2018]).

Intranasal: Natesto: Measure testosterone periodically, beginning 1 month after initiating therapy. Discontinue therapy if the total serum testosterone is consistently outside of the normal range.

Pellet (for subcutaneous implant): Testopel: Measure testosterone at the end of the dosing interval (Endocrine Society [Bhasin 2018]).

Topical: Note: Serum concentrations may vary substantially with topical gel or solution; single measurements may not consistently correspond to average testosterone levels, and may not adequately guide dosage adjustments (Muram 2016; Swerdloff 2015).

AndroGel 1%: Morning (pre-dose) serum testosterone levels ~14 days after start of therapy or dose adjustments.

AndroGel 1.62%: Morning (pre-dose) serum testosterone levels after 14 and 28 days of starting therapy or dose adjustments and periodically thereafter.

Androderm: Morning serum testosterone levels (following application the previous evening) ~14 days after start of therapy or dose adjustments.

Axiron: Serum testosterone levels can be measured 2 to 8 hours after application and after 14 days of starting therapy or dose adjustments.

Fortesta: Serum testosterone levels can be measured 2 hours after application and after 14 and 35 days of starting therapy or dose adjustments.

Testim: Morning (pre-dose) serum testosterone levels ~14 days after start of therapy or dose adjustments.

Vogelxo: Morning (pre-dose) serum testosterone ~14 days after initiation of therapy.

Hormone therapy in transgender males (female-to-male): Routine cancer and laboratory screening as in non-transgender individuals for all tissues present; serum testosterone levels every 3 months during the first year and then annually or biannually. Ensure testosterone levels remain within normal range for males throughout treatment (320 to 1,000 ng/dL).

Reference Range

Total testosterone normal reference range (CDC-certified labs):

2.5th and 97.5th percentile: 264 to 916 ng/dL

5th and 95th percentile: 303 to 852 ng/dL

Note: Due to diurnal fluctuations, diagnostic measurements should be obtained on at least 2 separate mornings while patient is fasting. Results from laboratories that are not CDC certified or otherwise standardized according to an accuracy-based quality control program may vary considerably (Endocrine Society [Bhasin 2018]).

Total testosterone therapeutic goal: 450 to 600 ng/dL (midnormal range for most labs) is a reasonable target for most patients on testosterone therapy to minimize potential for over- or under-treatment (AUA [Mulhall 2018]). For injectable formulations (IM, SubQ), a range of 350 to 600 ng/dL may be reasonable (Endocrine Society [Bhasin 2018]; Xyosted manufacturer labeling). Some data suggest a slightly lower testosterone target may be reasonable in older patients (eg, the lower end of the normal testosterone range) (AUA [Mulhall 2018]).

Free Testosterone: The normal free testosterone reference range varies by laboratory and a CDC harmonized standard has not yet been established; therefore, the Endocrine Society recommends referring to ranges established within each local laboratory (Endocrine Society [Bhasin 2018]).

Advanced Practitioners Physical Assessment/Monitoring

Obtain serum testosterone levels. When changing patch doses, measure early morning testosterone concentrations approximately 2 weeks later. Monitor more frequently depending on formulation and dose changes. Measure testosterone levels if patient exhibits serious cardiovascular or psychiatric adverse events. Obtain periodic liver function tests, renal function tests, and lipid panel. Obtain hemoglobin/hematocrit baseline. Assess for signs of virilization and obtain urine and serum calcium in breast cancer treatment patients. Obtain radiologic exam of wrist and hand every 6 months in prepubertal children. Obtain bone mineral density after 1 to 2 years of therapy. Obtain serum glucose in diabetic patients. Assess for response to treatment. Assess for signs and symptoms of cardiovascular events, urinary retention, and worsening sleep apnea. Obtain PSA and prostate exam as indicated. Evaluate for DVT and PE for patients who are symptomatic. Assess other medicines patient may be taking; alternate therapy or dosage adjustments may be needed. In patients receiving Aveed, monitor for signs of anaphylaxis for 30 minutes following injection.

Nursing Physical Assessment/Monitoring

Check lab and test results and report any abnormalities. Monitor blood pressure; monitor glucose level closely in patients with diabetes. Monitor patients receiving Aveed for anaphylaxis for 30 minutes after the injection. Educate patient to report signs and symptoms of cardiac events or hepatic impairment. Instruct patients on proper use. Instruct patient to avoid skin-to-skin contact with women and children where the testosterone has been applied topically.

Product Availability

Jatenzo (testosterone undecanoate) capsules: FDA approved March 2019; availability anticipated in 2019. Information pertaining to this product within the monograph is pending revision. Jatenzo is indicated fortestosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Consult the prescribing information for additional information.

Controlled Substance

C-III

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Gel, Nasal:

Natesto: 5.5 mg/actuation (7.32 g)

Gel, Transdermal:

AndroGel: 25 mg/2.5 g (1%) (2.5 g) [contains alcohol, usp]

AndroGel: 20.25 mg/1.25 g (1.62%) (1.25 g); 40.5 mg/2.5 g (1.62%) (2.5 g)

AndroGel: 50 mg/5 g (1%) (5 g) [contains alcohol, usp]

AndroGel Pump: 20.25 mg/actuation (1.62%) (75 g)

AndroGel Pump: 12.5 mg/actuation (1%) (75 g [DSC]) [contains alcohol, usp]

Fortesta: 10 mg/actuation (2%) (60 g) [odorless; contains propylene glycol, trolamine (triethanolamine)]

Testim: 50 mg/5 g (1%) (5 g) [contains alcohol, usp, propylene glycol, tromethamine]

Vogelxo: 50 mg/5 g (1%) (5 g) [contains alcohol, usp, tromethamine]

Vogelxo Pump: 12.5 mg/actuation (1%) (75 g) [contains alcohol, usp, tromethamine]

Generic: 25 mg/2.5 g (1%) (2.5 g); 20.25 mg/1.25 g (1.62%) (1.25 g); 40.5 mg/2.5 g (1.62%) (2.5 g); 10 mg/actuation (2%) (60 g); 12.5 mg/actuation (1%) (75 g); 20.25 mg/actuation (1.62%) (75 g); 50 mg/5 g (1%) (5 g)

Miscellaneous, Buccal:

Striant: 30 mg (60 ea)

Patch 24 Hour, Transdermal:

Androderm: 2 mg/24 hr (1 ea, 60 ea); 4 mg/24 hr (1 ea, 30 ea)

Pellet, Implant:

Testopel: 75 mg (10 ea, 100 ea)

Solution, Transdermal:

Axiron: 30 mg/actuation (90 mL [DSC]) [contains isopropyl alcohol]

Generic: 30 mg/actuation (90 mL)

Solution, Intramuscular, as cypionate:

Depo-Testosterone: 100 mg/mL (10 mL); 200 mg/mL (1 mL, 10 mL) [contains benzyl alcohol, benzyl benzoate]

Generic: 100 mg/mL (10 mL); 200 mg/mL (1 mL, 10 mL)

Solution, Intramuscular, as enanthate:

Generic: 200 mg/mL (5 mL)

Solution, Intramuscular, as undecanoate:

Aveed: 750 mg/3 mL (3 mL) [contains benzyl benzoate, castor oil (ricine oil)]

Solution Auto-injector, Subcutaneous [preservative free]:

Xyosted: 50 mg/0.5 mL (0.5 mL); 75 mg/0.5 mL (0.5 mL); 100 mg/0.5 mL (0.5 mL) [contains sesame oil]

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Andriol: 40 mg [DSC] [contains FD&C YELLOW #6 (SUNSET YELLOW)]

Generic: 40 mg

Gel, Nasal:

Natesto: 5.5 mg/actuation (1ea)

Gel, Transdermal:

AndroGel: 25 mg/2.5 g (1%) (2.5gm); 50 mg/5 g (1%) (5gm); 12.5 mg/actuation (1%) (1.25gm, 2.5gm, 75gm) [contains ALCOHOL, USP]

Testim: 1% (5gm) [contains ALCOHOL, USP, TROMETHAMINE]

Generic: 25 mg/2.5 g (1%) (2.5gm); 50 mg/5 g (1%) (5gm)

Patch 24 Hour, Transdermal:

Androderm: 2.5 mg/24 hr (1ea, 60ea); 5 mg/24 hr (30ea) [contains ALCOHOL, USP]

Solution, Transdermal:

Axiron: 30 mg/actuation (90ml[DSC]) [contains ISOPROPYL ALCOHOL, SOYBEANS (GLYCINE MAX)]

Solution, Intramuscular, as cypionate:

Depo-Testosterone: 100 mg/mL (1ml, 10ml) [contains BENZYL ALCOHOL, BENZYL BENZOATE]

Generic: 100 mg/mL (10ml)

Solution, Intramuscular, as enanthate:

Delatestryl: 200 mg/mL (5ml) [contains CHLOROBUTANOL (CHLOROBUTOL), SESAME OIL]

Generic: 200 mg/mL (10ml[DSC])

Anatomic Therapeutic Chemical (ATC) Classification
  • G03BA03
Generic Available (US)

May be product dependent

Pricing: US

Gel (AndroGel Pump Transdermal)

20.25 MG/ACT (1.62%) (per gram): $9.94

Gel (AndroGel Transdermal)

20.25 MG/1.25GM (1.62%) (per gram): $19.94

25 MG/2.5GM (1%) (per gram): $9.97

40.5 MG/2.5GM (1.62%) (per gram): $10.25

50 MG/5GM (1%) (per gram): $5.12

Gel (Fortesta Transdermal)

10 MG/ACT (2%) (per gram): $8.28

Gel (Natesto Nasal)

5.5 mg/ACT (per gram): $42.95

Gel (Testim Transdermal)

50 MG/5GM (1%) (per gram): $4.74

Gel (Testosterone Transdermal)

10 MG/ACT (2%) (per gram): $6.83 – $7.87

12.5 MG/ACT (1%) (per gram): $2.07 – $3.00

20.25 MG/ACT (1.62%) (per gram): $8.93 – $8.94

20.25 MG/1.25GM (1.62%) (per gram): $17.92 – $17.94

25 MG/2.5GM (1%) (per gram): $4.13 – $5.83

40.5 MG/2.5GM (1.62%) (per gram): $9.21 – $9.22

50 MG/5GM (1%) (per gram): $2.07 – $3.88

Gel (Vogelxo Pump Transdermal)

12.5 MG/ACT (1%) (per gram): $3.56

Gel (Vogelxo Transdermal)

50 MG/5GM (1%) (per gram): $3.56

Misc (Striant Buccal)

30 mg (per each): $15.93

Patch, 24-hour (Androderm Transdermal)

2 mg/24 hrs (per each): $12.32

4 mg/24 hrs (per each): $24.64

Pellet (Testopel Implant)

75 mg (per each): $119.15

Solution (Aveed Intramuscular)

750 mg/3 mL (per mL): $447.23

Solution (Depo-Testosterone Intramuscular)

100 mg/mL (per mL): $8.82

200 mg/mL (per mL): $24.00

Solution (Testosterone Cypionate Intramuscular)

100 mg/mL (per mL): $5.91 – $8.56

200 mg/mL (per mL): $21.60 – $23.18

Solution (Testosterone Enanthate Intramuscular)

200 mg/mL (per mL): $16.99 – $17.93

Solution (Testosterone Transdermal)

30 mg/ACT (per mL): $3.37 – $6.88

Solution Auto-injector (Xyosted Subcutaneous)

50 mg/0.5 mL (per 0.5 mL): $142.50

75 mg/0.5 mL (per 0.5 mL): $142.50

100 mg/0.5 mL (per 0.5 mL): $142.50

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Principal endogenous androgen responsible for promoting the growth and development of the male sex organs and maintaining secondary sex characteristics in androgen-deficient males

Pharmacodynamics/Kinetics

Duration (route and ester dependent): IM: Cypionate and enanthate esters: 2 to 4 weeks; Undecanoate: 10 weeks; Transdermal gel: 24 hours

Absorption: Transdermal gel: ~10% of applied dose

Protein binding: 98%; bound to sex hormone-binding globulin (40%) and albumin

Metabolism: Hepatic; forms metabolites, including dihydrotestosterone (DHT) and estradiol (both active)

Bioavailability: Oral capsule [Canadian product]: ~7%

Half-life elimination: Variable: 10 to 100 minutes; Testosterone cypionate: ~8 days

Time to peak: IM (undecanoate): 7 days (median; range: 4 to 42 days); Intranasal: ~40 minutes; Transdermal system: 8 hours (range: 4 to 12 hours); Buccal system: 10 to 12 hours; Oral capsule [Canadian product]: 4 to 5 hours; SubQ (enanthate): 11.9 hours (median; range: 5.8 to 168.7 hours) following weekly administration for 12 weeks

Excretion: Urine (90%; oral capsule [Canadian product]: 45% to 48%); feces (6%)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Buccal administration: Bitter taste, gum edema, gum or mouth irritation, gum tenderness, and taste perversion.

Effects on Bleeding

No information available to require special precautions

Index Terms

Delatestryl; Jatenzo; Testosterone Cypionate; Testosterone Enanthate; Testosterone Undecanoate

FDA Approval Date
December 24, 1953
References

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Xyosted (testosterone) [prescribing information]. Ewing, NJ: Antares Pharma, Inc; September 2018.

Brand Names: International

Andriol (EG, UA); Androderm (AU, BB, NZ); AndroForte (AU); Androgel (AE, BE, BH, CU, CZ, EE, FR, HK, HN, HU, IE, IT, LB, MY, NL, PL, RU, SA, SG, TH, TW, UA, VN); Andromen (EG); Andropatch (GR); Aquaviron (IN); Axiron (AU); Depo-Test (TH); Depo-Testosterone (BB, ZA); Intrinsa Patch (FR, IE); Itnogen (ES); Jenasteron (KR); Lowtiyel (MX); Nebido (BE, BH, EG, HU, IL, KW, LB, LV, MY, NL, QA, UA, VN); Omnadren (PL, UA); Primoniat Depot (CL); Primoteston Depot (AU, BF, BJ, CI, EC, ET, GH, GM, GN, KE, KR, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Primotestone Depot (AE); Proviron Depot (VE); Reandron (ES); Sustanon (BH, JO, SA); Testarzon (BE); Testex (ES); Testim (BE, DK, ES, GB, HU, IE, IS, LU, LV, MT, NO, PL, SI, SK); Testocaps (LU); Testoderm (AT); Testogel (BE, BG, DK, IE, IS, TR); Testom (RO); Testopatch (FR); Testosteron Ferring (AT); Testosteronum propionicum (PL); Testotop (LU); Testoviron (CY, JO, PK, SI, TR); Testoviron Depot (LK, QA, SA); Testoviron-Depot (AR, CH, CO, DE, DK, IL, PE, PT, PY, SE, UY); Tostran (GB, IE); Tostrex (ID); Tostrex Gel (KR); Virormone (AE, BH, CY, IQ, IR, JO, LY, OM, SA, SY, YE); Vivrone (PH); Y45 (BD)

Testosterone (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(tes TOS ter one)

Brand Names: US

Androderm; AndroGel; AndroGel Pump; Aveed; Axiron [DSC]; Depo-Testosterone; Fortesta; Natesto; Striant; Testim; Testopel; Vogelxo; Vogelxo Pump; Xyosted

Brand Names: Canada

Andriol; Androderm; AndroGel; Axiron; Delatestryl; Natesto; Testim

Warning
  • All products:
  • High blood pressure has happened with this drug. Have your blood pressure checked as you have been told by your doctor.
  • High blood pressure can raise the chance of heart attack, stroke, or death from heart disease. If you have high blood pressure or heart disease, talk with your doctor.
  • Testosterone undecanoate injection:
  • A very bad lung problem has happened with this drug. Allergic reactions have also happened with this drug. Sometimes, allergic reactions have been life-threatening. These reactions have happened while this drug was given and right after. These reactions can happen with any dose of this drug.
  • You will be watched closely by your doctor for 30 minutes after each dose. Call your doctor right away if you have chest pain, cough or the need to cough, dizziness, passing out, shortness of breath, sweating, or throat tightness.
  • You can only get this drug through the Aveed REMS Program.
  • Skin gel, skin solution:
  • Wash the site where the drug was used before it touches anyone else’s skin.
  • Do not let your skin that the gel or solution was used on touch any children’s or women’s skin. Cover treated part with clothes. Signs of puberty may happen in children.
  • If a woman or child touches the gel, she/he needs to wash the skin with soap and water.
What is this drug used for?
  • It is used to treat low testosterone levels.
  • It is used in certain children when puberty is delayed.
  • It is used to treat breast cancer in women.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • All products:
  • If you have an allergy to testosterone or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are male and have breast or prostate cancer.
  • If you have any of these health problems: Heart disease, kidney disease, or liver disease.
  • All injection products:
  • If you are a woman. Not all injection products are approved for use in women. Talk with your doctor to see if this product may be used in women. If you are a woman using this drug, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.
  • If the patient is a child. Not all injection products are approved for use in children. Talk with the doctor to see if this product may be used in children.
  • All products other than injection:
  • If you are a woman. This drug is not approved for use in women. If you are a woman using this drug, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.
  • If the patient is a child. Do not give this drug to a child.
  • Nose gel:
  • If you have problems with swelling of the lining of your nose like Sjogren’s syndrome.
  • If you have ever had any of these health problems: Broken nose within the past 6 months, nose or sinus problems, nose or sinus surgery, or broken nose that caused the inside of the nose to be crooked (deviated septum).
  • If you are using another drug in the nose.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • There may be a higher chance of prostate cancer. Talk with the doctor.
  • If you have an enlarged prostate, your signs can get worse while you use this drug. Call your doctor if this happens to you.
  • If you have sleep apnea, talk with your doctor. Sometimes, sleep apnea has gotten worse in people using testosterone.
  • Treatment with this drug may lead to higher cholesterol and triglycerides. The effect of these changes on heart health is not known. Talk with the doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this drug.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • Do not switch between different forms of this drug without first talking with the doctor.
  • Blood clots have happened with this drug. Tell your doctor if you have ever had a blood clot. Talk with your doctor.
  • This drug is an anabolic steroid. Anabolic steroid drugs have been abused and misused before. Anabolic steroid abuse can lead to dependence and very bad health problems. These health problems include heart or blood vessel problems, stroke, liver problems, and mental or mood problems. Talk with the doctor.
  • High calcium levels have happened with drugs like this one in some people with cancer. Call your doctor right away if you have signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach or throwing up, constipation, or bone pain.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • This drug is not approved for treating low testosterone levels caused by getting older. Talk with your doctor.
  • This drug may affect sperm in men. This may affect being able to father a child. Talk with the doctor.
  • Skin gel, skin solution:
  • Tell the doctor right away if a child or woman touches the gel or solution and has any bad effects. In children, these are forceful actions, enlarged sex organs, and early growth of pubic hair. In women, these are a deep voice, change in body hair, or pimples.
  • If a pregnant woman touches the gel or solution, call the doctor right away.
  • Nose gel:
  • If you have very bad nose problems like runny nose, stuffy nose, or postnasal drip, or if you have these problems and they do not go away, talk with your doctor. You may need to stop this drug or switch to another product.
  • Patch:
  • The patch may have metal. Take off the patch before an MRI.
  • Cheek tablet:
  • Be sure to inspect your gums where you put this drug on a regular basis. Talk with your doctor.
  • All injection products:
  • Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. Talk with the doctor to see if this product has benzyl alcohol in it.
  • Some products may be used in children. Growth in children and teens may be affected in some cases. Children may need regular growth checks. If you have questions, talk with your child’s doctor.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • For males, erections (hard penis) that happen often or that last a long time.
  • Passing urine more often.
  • Trouble passing urine.
  • Passing urine in a weak stream or drips.
  • Not able to control passing urine.
  • New or worse behavior or mood changes like depression or thoughts of killing yourself.
  • Enlarged breasts.
  • Breast pain.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Upset stomach or throwing up.
  • Trouble breathing when sleeping.
  • Feeling sleepy during the day.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Change in color of skin.
  • Change in size or shape of testicles.
  • Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Nose gel:
  • Nosebleed.
  • Dry nose.
  • Nose pain or irritation.
  • Runny nose.
  • Stuffy nose.
  • Nose scabs.
  • Sneezing.
  • Cheek tablet:
  • Gum changes.
  • Injection products used in females:
  • For females, a deep voice, facial hair, pimples, or period changes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Capsules:
  • Headache.
  • Diarrhea.
  • Heartburn.
  • Burping.
  • All other products:
  • Headache.
  • Pimples (acne).
  • Diarrhea.
  • Emotional ups and downs.
  • Feeling tired or weak.
  • Trouble sleeping.
  • Irritation where this drug is used.
  • Nose gel:
  • Cough.
  • Throat irritation.
  • Cheek tablet:
  • Change in taste.
  • Bad taste in your mouth.
  • Patch:
  • Back pain.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Capsules:
  • Take this drug with food.
  • Skin gel, skin solution:
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Do not take this drug by mouth. Use on your skin only.
  • Wash your hands before and after use.
  • Use this drug at the same time of day.
  • Not all products are the same strength. Read and follow label carefully.
  • Do not get this drug on other parts of your body or on other people.
  • Do not put on the genitals.
  • Keep out of your eyes.
  • Some products come in pumps. Some products come in packets. If you are using a pump, you will need to prime it before you use it the first time. Prime the pump as you are told in the package insert.
  • After putting this drug on, you will need to wait some time before you bathe, shower, or swim. Be sure you know how long you need to wait. Read the package insert for more details.
  • Let dry before covering with clothing.
  • Avoid fire, flames, or smoking until dry.
  • Skin gel:
  • Put on clean, dry, healthy skin.
  • Certain products are to be put on certain parts of the body. Be sure you know where to put this drug. Read the package insert for more details.
  • Skin solution:
  • Put on clean, dry, healthy skin using the applicator under the arm.
  • Do not use your fingers or hand to rub this drug into the skin.
  • Change armpits with each dose.
  • Allow skin to dry between uses.
  • If you use an antiperspirant or deodorant, put on at least 2 minutes before you put on this drug.
  • Nose gel:
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Do not take this drug by mouth. Use in your nose only. Keep out of your mouth and eyes (may burn).
  • If you get this drug on the skin, wash it off right away with soap and water.
  • Use this drug at the same time of day.
  • Wash your hands before and after use.
  • You will need to prime the pump before first use. Do this by turning it upside down and pressing down on the pump 10 times. If any drug comes out during priming, wash down the sink with warm water.
  • Blow your nose before use.
  • Do not blow your nose or sniff for 1 hour after using this drug.
  • Follow how to clean carefully.
  • Patch:
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Do not use patches that are cut or do not look right.
  • Put patch on clean, dry, healthy skin on back, belly, thigh, or upper arm.
  • Do not put on an area that is bony. Do not put on an area that will have pressure on it for a long time while sleeping or sitting.
  • Do not put on the genitals.
  • Do not put on skin that is oily, sweats a lot, or has hair on it. The patch may not stick well.
  • Put on a new patch at the same time every night. Be sure to take off the old patch before you put on the new one.
  • Move the patch site with each new patch. Do not put on the same site for 7 days.
  • Do not bathe, shower, or swim for 3 hours after putting on.
  • Do not cover the patch with other bandages or tape. If the patch does not stick well, talk with your doctor or pharmacist.
  • If your patch falls off before noon, put on a new patch and wear it until you put on a new patch at your normal time.
  • If your patch falls off after noon, do not put on a new one. Wait and put on a new patch at your normal time.
  • After you take off a skin patch, be sure to fold the sticky sides of the patch to each other. Throw away used patches where children and pets cannot get to them.
  • Cheek tablet:
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Do not take this drug out of the blister pack until you are ready to take it. Take this drug right away after opening the blister pack. Do not store the removed drug for future use.
  • Wash your hands before use.
  • Dry your hands and place the tablet in your mouth above the incisor tooth between the upper cheek and gum. Leave the tablet in place until it dissolves.
  • Do not chew or swallow.
  • Change the side of mouth with each dose.
  • Do not take out until it is time for your next dose.
  • Make sure drug is still in place after eating, drinking, brushing your teeth, or using mouthwash.
  • If the drug does not stick or falls out, follow what your doctor has told you or read the package insert. If you are not sure what to do, talk with your doctor.
  • To remove tablet, gently slide it down from the gum toward the tooth to keep from scratching the gum.
  • All injection products:
  • Some products need to be given into the fatty part of the skin. Some products need to be given into a muscle. Talk with your doctor or pharmacist if you are not sure how to use this drug.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Wash your hands before use.
  • Be sure you know where to give the shot. If you are not sure where to give the shot, talk with the doctor.
  • Do not give into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • This drug is colorless to a faint yellow. Do not use if the solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
What do I do if I miss a dose?
  • Testosterone undecanoate injection:
  • Call your doctor to find out what to do.
  • All other products:
  • Use a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not use 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • All products other than injection:
  • Store at room temperature. Do not freeze.
  • Store in a dry place. Do not store in a bathroom.
  • Skin gel, skin solution:
  • Protect from heat or open flame.
  • Cheek tablet:
  • Protect from heat.
  • Patch:
  • Store in pouch until ready for use.
  • All injection products:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Testosterone (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(tes TOS ter one)

Brand Names: US

Androderm; AndroGel; AndroGel Pump; Aveed; Axiron [DSC]; Depo-Testosterone; Fortesta; Natesto; Striant; Testim; Testopel; Vogelxo; Vogelxo Pump; Xyosted

Brand Names: Canada

Andriol; Androderm; AndroGel; Axiron; Delatestryl; Natesto; Testim

What is this drug used for?
  • Testosterone cypionate and testosterone enanthate injection:
  • It is used to treat low testosterone levels.
  • It is used in certain children when puberty is delayed.
  • It may be given to your child for other reasons. Talk with the doctor.
  • All other products:
  • This drug is not approved for use in children. Talk with the doctor.
  • If your child has been given this form of this drug, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions or concerns about giving this drug to your child.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is male and has breast or prostate cancer.
  • If your child has heart problems.
  • If your child has any of these health problems: Kidney disease or liver disease.
  • If your child is pregnant or breast-feeding a baby:
  • If your child is a female. Not all products are approved for use in females. Talk with your child’s doctor to see if this product may be used in females. If your child is a female using this drug, talk with your child’s doctor if she is pregnant, plans on getting pregnant, or is breast-feeding.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
  • There may be a higher chance of prostate cancer. Talk with the doctor.
  • If your child has an enlarged prostate, his signs can get worse while using this drug. Call the doctor if this happens to your child.
  • High blood pressure has happened with this drug. Have your blood pressure checked as you have been told by your doctor.
  • High blood pressure can raise the chance of heart attack, stroke, or death from heart disease. If your child has high blood pressure or heart disease, talk with your child’s doctor.
  • If your child has sleep apnea, talk with your child’s doctor. Sometimes, sleep apnea has gotten worse in people using testosterone.
  • Treatment with this drug may lead to higher cholesterol and triglycerides. The effect of these changes on heart health is not known. Talk with the doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Do not switch between different forms of this drug without first talking with the doctor.
  • Blood clots have happened with this drug. Tell the doctor if your child has ever had a blood clot.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • If your child is taking warfarin, talk with the doctor. Your child may need to have blood work checked more closely while taking it with this drug.
  • This drug is an anabolic steroid. Anabolic steroid drugs have been abused and misused before. Anabolic steroid abuse can lead to dependence and very bad health problems. These health problems include heart or blood vessel problems, stroke, liver problems, and mental or mood problems. Talk with the doctor.
  • This drug may affect sperm in males. This may affect being able to father a child later in life. Talk with the doctor.
  • Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. Talk with the doctor to see if this product has benzyl alcohol in it.
  • Not all injection products are approved for use in children. Talk with the doctor to see if this product may be used in children.
  • Use with care in children. Talk with the doctor.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Passing urine more often.
  • Trouble passing urine.
  • Passing urine in a weak stream or drips.
  • Not able to control passing urine.
  • New or worse behavior or mood changes like depression or thoughts of killing yourself.
  • Enlarged breasts.
  • Breast pain.
  • Upset stomach or throwing up.
  • Trouble breathing when sleeping.
  • Feeling sleepy during the day.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Change in color of skin.
  • Change in size or shape of testicles.
  • For females, a deep voice, facial hair, pimples, or period changes.
  • For males, erections (hard penis) that happen often or that last a long time.
  • Call the doctor right away if your child has signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call the doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • High calcium levels have happened with drugs like this one in some people with cancer. Call your child’s doctor right away if your child has signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach or throwing up, constipation, or bone pain.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Pimples (acne).
  • Diarrhea.
  • Emotional ups and downs.
  • Feeling tired or weak.
  • Trouble sleeping.
  • Irritation where the shot is given.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • It is given as a shot into a muscle.
  • If you will be giving your child the shot, your child’s doctor or nurse will teach you how to give the shot.
  • Follow how to give this drug as you have been told by your child’s doctor or read the package insert.
  • Wash your hands before use.
  • Be sure you know where to give the shot. If you are not sure where to give the shot, talk with the doctor.
  • Do not give into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • This drug is colorless to a faint yellow. Do not use if the solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature. Do not freeze.
  • Store in the carton to protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.