Insulin Glargine (Lexi-Drugs)

Pronunciation

(IN soo lin GLAR jeen)

Brand Names: US

Basaglar KwikPen; Lantus; Lantus SoloStar; Toujeo Max SoloStar; Toujeo SoloStar

Brand Names: Canada

Basaglar; Basaglar KwikPen; Lantus; Lantus SoloStar; Toujeo SoloStar

Pharmacologic Category

Insulin, Long-Acting

Dosing: Adult

Note: Insulin glargine is a long-acting insulin. Insulin requirements vary dramatically between patients and dictates frequent monitoring and close medical supervision.

Diabetes mellitus, type 1: SubQ:

Note: Insulin glargine must be used concomitantly with rapid- or short-acting insulins (ie, multiple daily injection regimen). The total daily doses (TDD) presented below are expressed as the total units/kg/day of all insulin formulations combined.

General insulin dosing:

Initial TDD: ~0.4 to 0.5 units/kg/day (AACE/ACE [Handelsman 2015]; ADA 2018); conservative initial doses of 0.2 to 0.4 units/kg/day may be considered to avoid the potential for hypoglycemia; higher initial doses may be required in patients who are obese, sedentary, or presenting with ketoacidosis (AACE/ACE [Handelsman 2015]; ADA 2018).

Usual TDD maintenance range: 0.4 to 1 units/kg/day in divided doses (ADA 2018)

Division of TDD (multiple daily injections):

Basal insulin: Generally, 40% to 50% of the TDD is given as basal insulin (intermediate- or long-acting) (AACE/ACE [Handelsman 2015]; ADA 2018). Insulin glargine may be administered as a single daily dose (manufacturer’s labeling); in some cases administration of insulin glargine (Lantus formulation) as 2 divided doses may be beneficial (Ashwell 2006; Youssef 2010).

Prandial insulin: The remaining portion (ie, 50% to 60%) of the TDD is then divided and administered before or at mealtimes (depending on the formulation) as a rapid-acting (eg, aspart, glulisine, lispro; insulin for inhalation) or short-acting (regular) insulin (AACE/ACE [Handelsman 2015]; ADA 2018).

Dosage adjustment: Dosage must be titrated to achieve glucose control and avoid hypoglycemia. Adjust dose to maintain premeal and bedtime glucose in target range. Since combinations of agents are frequently used, dosage adjustment must address the individual component of the insulin regimen which most directly influences the blood glucose value in question, based on the known onset and duration of the insulin component. To minimize hypoglycemia risk, basal insulins are generally titrated once or twice weekly (eg, every 3 or 7 days) (ADA 2018; McCall 2012).

Diabetes mellitus, type 2: SubQ: Note: Basal insulin therapy is usually initiated if adequate glycemic control has not been achieved with step-wise trials of metformin +/- other noninsulin agents. However, if HbA1c ≥10%, blood glucose is ≥300 mg/dL or if patient is symptomatic (eg, polyuria, polydipsia), insulin (with or without additional agents) should be considered as part of initial therapy (ADA 2018). Use of long-acting basal analogs may be preferred if minimization of hypoglycemia is a primary concern (ADA-EASD [Davies 2018]).

Initial:10 units or 0.1 to 0.2 units/kg once daily (ADA 2018; manufacturer’s labeling). If HbA1c >8% prior to initiation of basal insulin, 0.2 to 0.3 units/kg once daily is recommended (AACE/ACE [Garber 2018]).

Dosage adjustment (ADA 2018):

To reach fasting blood glucose target: Adjust dose by 10% to 15% or 2 to 4 units; may adjust at weekly or twice weekly intervals.

For hypoglycemia: If no clear reason for hypoglycemia, decrease dose by 4 units or by 10% to 20%.

Dosage adjustment when adding prandial insulin (ADA/EASD [Davies 2018]): Consider reducing the basal insulin dose by 4 units (or ~10%) if HbA1c is <8% when initiating prandial insulin.

Patients with diabetes receiving enteral feedings (ADA 2018): Note: TDD of insulin is divided into a basal component (intermediate- or long-acting insulin) and nutritional and correctional components (regular insulin or rapid-acting insulins).

Basal component: SubQ: Continue previous basal insulin dose or administer 30% to 50% of current TDD as insulin glargine; if basal insulin naive, administer insulin glargine 10 units once daily.

Patients with diabetes undergoing surgery (ADA 2018): SubQ: On the morning of surgery or procedure, give 60% to 80% of the usual dose of long-acting analogs (eg, glargine, degludec, or detemir).

Conversion to insulin glargine from other insulin therapies:

Converting from once-daily NPH insulin to insulin glargine: May be substituted on an equivalent unit-per-unit basis

Converting from twice-daily NPH insulin to insulin glargine: Initial dose: Use 80% of the total daily dose of NPH (eg, 20% reduction); administer once daily; adjust dosage according to patient response

Conversion between Toujeo, Lantus, or Basaglar:

Conversion from once-daily Toujeo to once-daily Lantus or once-daily Basaglar: Initial dose: Use 80% of the dose of Toujeo (eg, 20% reduction); adjust dosage according to patient blood glucose response.

Conversion from once-daily Lantus to once-daily Toujeo or once-daily Basaglar: Initial dose: May be substituted on an equivalent unit-per-unit basis; however, generally a higher daily dosage of Toujeo will be required to achieve the same level of glycemic control as with Lantus.

Conversion between Toujeo SoloStar and Toujeo Max SoloStar: If previous dose was an odd number, the dose should be increased or decreased by 1 unit.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; insulin requirements may be reduced due to changes in insulin clearance or metabolism; monitor blood glucose closely.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; insulin requirements may be reduced due to changes in insulin clearance or metabolism; monitor blood glucose closely.

Dosing: Pediatric

Insulin glargine is a long-acting insulin. Insulin glargine is approximately equipotent to human insulin, but has a slower onset, no pronounced peak, and a longer duration of activity. Insulin doses should be individualized based on patient needs; adjustments may be necessary with changes in physical activity, meal patterns, acute illness, or with changes in renal or hepatic function. Insulin requirements vary dramatically between patients and dictates frequent monitoring and close medical supervision. Insulin regimens vary widely by region, practice, and institution; consult institution-specific guidelines.

Type 1 diabetes mellitus: Children and Adolescents: Note: For basal insulin coverage, long-acting insulin analogs are preferred over insulin NPH due to decreased risk of hypoglycemia (AACE/ACE [Handelsman 2015]; ADA 2018; ADA [Chiang 2014]). Insulin glargine must be used in combination with a rapid or short-acting insulin. The daily doses presented are expressed as the total units/kg/day of all insulin formulations used.

Insulin glargine-specific dosing: Note: All pediatric patients should have rapid-acting or regular insulin available for crisis management (ISPAD [Danne 2018])

Initial dose: Children ≥6 years and Adolescents: Lantus, Basaglar: SubQ: Approximately one-third of the total daily insulin requirement administered once daily; a rapid-acting or short-acting insulin should also be used to complete the balance (~2/3) of the total daily insulin requirement. Adjust dosage according to patient response.

Conversion to insulin glargine from NPH insulin: Children ≥2 years and Adolescents: SubQ: Note: Limited data available in children <6 years of age (Colino 2005)

Converting from once-daily NPH insulin to insulin glargine: May be substituted on an equivalent unit-per-unit basis

Converting from twice-daily NPH insulin to insulin glargine: Initial dose: Use 80% of the total daily dose of NPH (eg, 20% reduction); administer once daily; adjust dosage according to patient response.

General insulin dosing:

Initial total daily insulin: SubQ: Initial: 0.4 to 0.5 units/kg/day in divided doses (AACE/ACE [Handelsman 2015]; ADA 2018); Usual range: 0.4 to 1 units/kg/day in divided doses (AACE/ACE [Handelsman 2015]; ADA 2018; Silverstein 2005); lower doses (0.25 units/kg/day) may be used especially in young children to avoid potential hypoglycemia (Beck 2015); higher doses may be necessary for some patients (eg, obese, concomitant steroids, puberty, sedentary lifestyle, following diabetic ketoacidosis presentation) (AACE/ACE [Handelsman 2015]; ADA 2018)

Usual total daily maintenance range: SubQ: Doses must be individualized; however, an estimate can be determined based on phase of diabetes and level of maturity (ISPAD [Danne 2018]; ISPAD [Sundberg 2017]).

Partial remission phase (Honeymoon phase): <0.5 units/kg/day

Prepubertal children (not in partial remission):

Infants ≥6 months and Children ≤6 years: 0.4 to 0.8 units/kg/day

Children ≥7 years: 0.7 to 1 units/kg/day

Pubescent Children and Adolescents: During puberty, requirements may substantially increase to >1 unit/kg/day and in some cases up to 2 units/kg/day

Division of daily insulin requirement (multiple daily injections):

Basal insulin: Generally, ~30% to 50% of the total daily insulin is given as basal insulin (intermediate- or long-acting) in 1 to 2 daily injections (AACE/ACE [Handelsman 2015]; ADA 2018; ISPAD [Danne 2018]; Peters 2013).

Prandial insulin: The remaining portion of the total daily dose is then divided and administered before or at mealtimes (depending on the formulation) as a rapid-acting (eg, aspart, glulisine, lispro) or short-acting (regular). In most type 1 patients, the use of a rapid-acting insulin analog is preferred over regular insulin to reduce hypoglycemia risk (AACE/ACE [Handelsman 2015]; ADA 2018; ADA [Chiang 2014]; ISPAD [Danne 2018]).

Dosage titration: Treatment and monitoring regimens must be individualized to maintain premeal and bedtime glucose in target range; titrate dose to achieve glucose control and avoid hypoglycemia. Since combinations of agents are frequently used, dosage adjustment must address the individual component of the insulin regimen which most directly influences the blood glucose value in question, based on the known onset and duration of the insulin component.

Surgical patients (ISPAD [Jefferies 2018]): Note: Diabetic patients should be scheduled as the first case of the day.

Minor surgeries:

Morning procedure: Administer the usual insulin glargine dose (if usually given in the morning); may consider reducing dose to 70% to 80% of usual dose if preoperative evaluation shows low morning blood glucose values. Alternatively, may administer IV insulin (regular) infusion; begin IV fluids containing dextrose; in general rapid acting insulin should be omitted until after surgery and patient is able to eat unless it is needed to correct significant hyperglycemia and/or significant ketone (>0.1 mmol/mol) production is present.

Afternoon procedure: Administer the usual morning dose of insulin glargine (if usually given in the morning).

Postprocedure: Once normal oral intake is achieved, resume usual insulin regimen; monitor closely due to risk of changes related to surgery (ie, postoperative stress, medication changes, inactivity).

Major surgeries:

Evening prior to surgery: If patient normally receives evening insulin doses, administer 50% to 100% of the usual evening and/or bedtime insulin glargine; patients on continuous subcutaneous insulin infusion (CSII) may continue normal insulin basal rates overnight; if there is a concern for hypoglycemia, basal rate may be reduced by 20% at ~3 am.

Morning of surgery: Omit morning insulin (short- and long-acting) and start IV insulin (regular) infusion and IV fluids containing dextrose; patients on CSII should discontinue CSII when IV insulin infusion is started; once normal oral intake is resumed, then resume usual insulin regimen; monitor closely due to risk of changes related to surgery (ie, postoperative stress, medication changes, inactivity).

Type 2 diabetes mellitus: Limited data available: Note: The goal of therapy is to achieve an HbA1c <7% as quickly as possible using the safe titration of medications. Initial therapy in metabolically unstable patients (eg, plasma glucose ≥250 mg/dL, HbA1c >9% and symptoms excluding acidosis) may include once daily intermediate-acting insulin or basal insulin in combination with lifestyle changes and metformin. In patients who fail to achieve glycemic goals with metformin and basal insulin, may consider initiating prandial insulin (regular insulin or rapid-acting insulin) and titrate to achieve goals. Once initial goal reached, insulin should be slowly tapered over 2 to 6 weeks by decreasing the insulin dose by 10% to 30% every few days and the patient transitioned to lowest effective doses or metformin monotherapy if able (AAP [Copeland 2013]; ADA 2018; ISPAD [Zeitler 2018]). Note: Patients who are ketotic or present with ketoacidosis require aggressive management as indicated.

General insulin dosing:

Children ≥10 years and Adolescents with ketosis/ketoacidosis/ketonuria: SubQ: Initial: 0.25 to 0.5 units/kg/dose once daily; use in in combination with lifestyle changes and metformin to achieve goals (ISPAD [Zeitler 2018])

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling; insulin requirements are reduced due to changes in insulin clearance or metabolism; monitor blood glucose closely.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling; insulin requirements may be reduced due to changes in insulin clearance or metabolism; monitor blood glucose closely.

Use: Labeled Indications

Diabetes mellitus, types 1 and 2: To improve glycemic control in adults with type 1 diabetes mellitus and type 2 diabetes mellitus; to improve glycemic control in children ≥6 years of age with type 1 diabetes mellitus (Lantus and Basaglar only)

Clinical Practice Guidelines

Diabetes Mellitus:

American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE), “Consensus Statement on the Comprehensive Type 2 Diabetes Management Algorithm- 2018 Executive Summary”, January 2018

American Diabetes Association, “Standards of Medical Care in Diabetes – 2018,” January 2018

Diabetes Canada, “Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada,” 2018

Administration: Subcutaneous

Do not use if solution is viscous or cloudy; use only if clear and colorless with no visible particles. Insulin glargine should be administered consistently at the same time each day. Cold injections should be avoided. SubQ administration is usually made into the thighs, arms, buttocks, or abdomen; absorption rates vary amongst injection sites; be consistent with area used while rotating injection sites within the same region to avoid lipodystrophy. Do not dilute or mix insulin glargine with any other insulin formulation or solution. Insulin glargine prefilled pens are available in concentrations of 100 units/mL and 300 units/mL. Prefilled pens are calibrated to display the actual insulin units administered (no dosage conversion needed) and will administer up to 80 units per injection, in 1 unit increments (Lantus SoloStar, Basaglar KwikPen, Toujeo SoloStar) or up to 160 units per injection, in 2 unit increments (Toujeo Max SoloStar). Toujeo Max SoloStar prefilled pens are recommended for use in patients requiring at least 20 units of insulin glargine per day. Do not use a syringe to withdraw concentrated insulin glargine (300 units/mL) from a prefilled pen for administration. Cartridges [Canadian product] are to be used only with re-usable pens recommended by the manufacturer (refer to product labeling).

Administration: Pediatric

SubQ: Do not use if solution is viscous or cloudy; use only if clear and colorless with no visible particles. Administer into the subcutaneous fat of the thighs, arms, buttocks, or abdomen; do not administer IV or in an insulin pump. Rotate injection sites within the same region to reduce the risk of lipodystrophy. Cold injections should be avoided. Administer consistently at the same time each day. Do not mix with any other insulin or solution.

Insulin glargine prefilled pens are available in concentrations of 100 units/mL and 300 units/mL. Prefilled pens are calibrated to display the actual insulin units administered (no dosage conversion needed) and will administer up to 80 units per injection (Lantus, Basaglar, Toujeo SoloStar) or up to 160 units per injection (Toujeo Max SoloStar). Toujeo Max SoloStar prefilled pens are recommended for use in patients requiring at least 20 units of insulin glargine per day. Do not use a syringe to withdraw concentrated insulin glargine (300 units/mL) from a prefilled pen for administration.

Dietary Considerations

Individualized medical nutrition therapy (MNT) based on ADA recommendations is an integral part of therapy.

Storage/Stability

Basaglar:

Prefilled pens: Store unopened prefilled pens at room temperature <30°C (<86°F) for 28 days, or refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date. Once in use, store prefilled pens at room temperature <30°C (<86°F) and use within 28 days; do not refrigerate. Do not freeze or use if previously frozen; protect from heat and light.

Cartridges [Canadian product]: Store unopened cartridges refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date. Once in use, store cartridges at room temperature <30°C (<86°F) and use within 28 days; do not refrigerate. Do not freeze or use if previously frozen; protect from heat and light.

Lantus: Store unopened vials and prefilled pens refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date, or at room temperature <30°C (<86°F) for 28 days; do not freeze; protect from heat and sunlight. Once punctured (in use), store vials refrigerated or at room temperature <30°C (<86°F) and use within 28 days. Store prefilled pens (SoloStar) that have been punctured (in use) at temperatures <30°C (<86°F) and use within 28 days; do not freeze or refrigerate.

Toujeo: Store unopened prefilled pen (SoloStar or Max SoloStar) at 2°C to 8°C (36°F to 46°F) until expiration date; do not freeze (discard pen if it has been frozen). Store prefilled pens (SoloStar or Max SoloStar) that have been opened (in use) at <30°C (<86°F) and use within 56 days; do not freeze or refrigerate. Protect from heat and light.

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 injection site irritation, back pain, diarrhea, rhinitis, or pharyngitis. Have patient report immediately to prescriber signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), signs of infection, vision changes, severe headache, severe dizziness, passing out, seizures, shortness of breath, excessive weight gain, swelling of arms or legs, depression, or change in skin to thick or thin at injection site (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:
  High alert medication:
  Administration issues:
  Other safety concerns:
  International issues:
Contraindications

Hypersensitivity to insulin glargine or any component of the formulation; during episodes of hypoglycemia

Documentation of allergenic cross-reactivity for insulin 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:

• Glycemic control: Hyper- or hypoglycemia may result from changes in insulin strength, manufacturer, type, and/or administration method. The most common adverse effect of insulin is hypoglycemia. The timing of hypoglycemia differs among various insulin formulations. Hypoglycemia may result from changes in meal pattern (eg, macronutrient content, timing of meals), changes in the level of physical activity, increased work or exercise without eating, or changes to coadministered medications. Use of long-acting insulin preparations (eg, insulin degludec, insulin detemir, insulin glargine) may delay recovery from hypoglycemia. Patients with renal or hepatic impairment may be at a higher risk. Symptoms differ in patients and may change over time in the same patient; awareness may be less pronounced in those with long-standing diabetes, diabetic nerve disease, patients taking beta-blockers, or in those who experience recurrent hypoglycemia. Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death. Insulin requirements may be altered during illness, emotional disturbances, or other stressors. Instruct patients to use caution with ethanol; may increase risk of hypoglycemia. In clinical trials insulin NPH has been associated with a modestly increased risk of hypoglycemia (including nocturnal hypoglycemia) compared to long-acting analogs (Lipska 2017; Rosenstock 2005; Rys 2015; Singh 2009). However, an observational study in patients with type 2 diabetes from a large health care delivery system found no difference in the incidence of ER visits or hospitalization for hypoglycemia with NPH compared to glargine/detemir when treating to conventional targets in a real world setting (Lipska 2018).

• Hypersensitivity: Severe, life-threatening allergic reactions, including anaphylaxis, may occur. If hypersensitivity reactions occur, discontinue therapy.

• Hypokalemia: Insulin (especially IV insulin) causes a shift of potassium from the extracellular space to the intracellular space, possibly producing hypokalemia. If left untreated, hypokalemia may result in respiratory paralysis, ventricular arrhythmia and even death. Use with caution in patients at risk for hypokalemia (eg, loop diuretic use). Monitor serum potassium and supplement potassium when necessary.

Disease-related concerns:

• Diabetic ketoacidosis: Should not be used in patients with diabetic ketoacidosis (DKA); use of an IV rapid acting or short acting insulin is preferred.

• Hepatic impairment: Use with caution in patients with hepatic impairment. Dosage requirements may be reduced.

• Renal impairment: Use with caution in patients with renal impairment. Dosage requirements may be reduced.

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:

• Hospitalized patients with diabetes: Exclusive use of a sliding scale insulin regimen (insulin regular) in the inpatient hospital setting is strongly discouraged. In the critical care setting, continuous IV insulin infusion (insulin regular) has been shown to best achieve glycemic targets. In noncritically ill patients with either poor oral intake or taking nothing by mouth, basal insulin or basal plus bolus is preferred. In noncritically ill patients with adequate nutritional intake, a combination of basal insulin, nutritional, and correction components is preferred. An effective insulin regimen will achieve the goal glucose range without the risk of severe hypoglycemia. A blood glucose value <70 mg/dL should prompt a treatment regimen review and change, if necessary, to prevent further hypoglycemia (ADA 2018).

Dosage form specific issues:

• Multiple dose injection pens: According to the Centers for Disease Control and Prevention (CDC), pen-shaped injection devices should never be used for more than one person (even when the needle is changed) because of the risk of infection. The injection device should be clearly labeled with individual patient information to ensure that the correct pen is used (CDC 2012).

Other warnings/precautions:

• Administration: Insulin glargine is a clear solution, but it is NOT intended for IV or IM administration or via an insulin pump.

• Patient education: Diabetes self-management education (DSME) is essential to maximize the effectiveness of therapy.

Geriatric Considerations

Intensive glucose control (HbA1c <6.5%) has been linked to increased all-cause and cardiovascular mortality, hypoglycemia requiring assistance, and weight gain in adult type 2 diabetes. How “tightly” to control a geriatric patient’s blood glucose needs to be individualized. Such a decision should be based on several factors, including the patient’s functional and cognitive status, how well he/she recognizes hypoglycemic or hyperglycemic symptoms, and how to respond to them and other disease states. An HbA1c <7.5% is an acceptable endpoint for a healthy older adult, while <8% is acceptable for frail elderly patients, those with a duration of illness >10 years, or those with comorbid conditions and requiring combination diabetes medications. In patients with advanced microvascular complications and/or a life expectancy <5 years, a target HbA1c of 8% to 9% is reasonable. Patients who are unable to accurately draw up their dose will need assistance, such as prefilled syringes. Initial doses may require considerations for renal function in the elderly with dosing adjusted subsequently based on blood glucose monitoring. For elderly patients with diabetes who are relatively healthy, attaining target goals for aspirin use, blood pressure, lipids, smoking cessation, and diet and exercise may be more important than normalized glycemic control.

Pregnancy Considerations

In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 2005; ADA 2018; Metzger 2007). To prevent adverse outcomes, prior to conception and throughout pregnancy maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ADA 2018; Blumer 2013; Lambert 2013).

Insulin requirements tend to fall during the first trimester of pregnancy and increase in the later trimesters, peaking at 28 to 32 weeks’ gestation. Following delivery, insulin requirements decrease rapidly (ACOG 2005).

Insulin therapy is the preferred treatment of type 1 and type 2 diabetes in pregnant women, as well as GDM when pharmacologic therapy is needed (ACOG 190 2018; ADA 2018). Because insulin glargine has an increased affinity to the insulin-like growth factor (IGF-I) receptor, there are theoretical concerns that it may contribute to adverse events when used during pregnancy (Jovanovic 2007; Lambert 2013), although this has not been observed in available studies (Lambert 2013; Lepercq 2012; Pollex 2011). Women who are stable on insulin glargine prior to conception may continue it during pregnancy. Theoretical concerns of insulin glargine should be discussed prior to conception (Blumer 2013).

Breast-Feeding Considerations

In a study using insulin glargine, both exogenous and endogenous insulin were present in breast milk (Whitmore 2012). Breastfeeding is encouraged for all women, including those with type 1, type 2, or GDM (ACOG 2005; ADA 2018; Blumer 2013; Metzger 2007). A small snack (such as milk) before breastfeeding may help decrease the risk of hypoglycemia in women with pregestational diabetes (ACOG 2005; Reader 2004). The manufacturer considers the use of insulin glargine to be compatible with breastfeeding, although adjustments of the mother’s insulin dose may be needed.

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Primarily symptoms of hypoglycemia.

>10%

Cardiovascular: Hypertension (20%), peripheral edema (20%)

Central nervous system: Depression (11%)

Endocrine & metabolic: Hypoglycemia (Type I on combination regimens: ≤69%; Type II on combination regimens: ≤8%; monotherapy in adults ≥50 years old: 6% [ORIGIN trial])

Gastrointestinal: Diarrhea (11%)

Genitourinary: Urinary tract infection (11%)

Immunologic: Antibody development (20% to 44%; effect on therapy not reported)

Infection: Influenza (19%), infection (9% to 14%)

Neuromuscular & skeletal: Arthralgia (14%), back pain (13%), limb pain (13%)

Ophthalmic: Cataract (18%), retinopathy (14%)

Respiratory: Upper respiratory tract infection (adults: 6% to 29%; children & adolescents: 14%), sinusitis (19%), bronchitis (15%), nasopharyngitis (7% to 13%), cough (12%)

1% to 10%:

Cardiovascular: Retinal vascular disease (6%)

Central nervous system: Headache (6% to 10%)

Local: Pain at injection site (3%)

Respiratory: Pharyngitis (children & adolescents: 8%), rhinitis (children & adolescents: 5%)

Miscellaneous: Accidental injury (6%)

Frequency not defined:

Endocrine & metabolic: Sodium retention

Local: Erythema at injection site, itching at injection site, localized edema, swelling at injection site

<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, bronchospasm, hyperglycemia, hypersensitivity reaction, hypertrophy at injection site, hypokalemia, hypotension, injection site reaction (including urticaria and inflammation), lipoatrophy at injection site, lipoatrophy at injection site, shock, skin rash, weight gain

Allergy and Idiosyncratic Reactions
Toxicology
Metabolism/Transport Effects

None known.

Drug Interactions 

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

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

Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Beta-Blockers: May enhance the hypoglycemic effect of Insulins. Exceptions: Levobunolol; Metipranolol. Risk C: Monitor therapy

Dipeptidyl Peptidase-IV Inhibitors: May enhance the hypoglycemic effect of Insulins. Management: Consider a decrease in insulin dose when initiating therapy with a dipeptidyl peptidase-IV inhibitor and monitor patients for hypoglycemia. Risk D: Consider therapy modification

Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Edetate CALCIUM Disodium: May enhance the hypoglycemic effect of Insulins. Risk C: Monitor therapy

Glucagon-Like Peptide-1 Agonists: May enhance the hypoglycemic effect of Insulins. Management: Consider insulin dose reductions when used in combination with glucagon-like peptide-1 agonists. Avoid the use of lixisenatide in patients receiving both basal insulin and a sulfonylurea. Exceptions: Liraglutide. Risk D: Consider therapy modification

Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Herbs (Hypoglycemic Properties): May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Liraglutide: May enhance the hypoglycemic effect of Insulins. Management: If liraglutide is used for the treatment of diabetes (Victoza), consider insulin dose reductions. The combination of liraglutide and insulin should be avoided if liraglutide is used exclusively for weight loss (Saxenda). Risk D: Consider therapy modification

Macimorelin: Insulins may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination

Maitake: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Metreleptin: May enhance the hypoglycemic effect of Insulins. Management: Insulin dosage adjustments (including potentially large decreases) may be required to minimize the risk for hypoglycemia with concurrent use of metreleptin. Monitor closely. Risk D: Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Pioglitazone: May enhance the adverse/toxic effect of Insulins. Specifically, the risk for hypoglycemia, fluid retention, and heart failure may be increased with this combination. Management: If insulin is combined with pioglitazone, dose reductions should be considered to reduce the risk of hypoglycemia. Monitor patients for fluid retention and signs/symptoms of heart failure. Risk D: Consider therapy modification

Pramlintide: May enhance the hypoglycemic effect of Insulins. Management: Upon initiation of pramlintide, decrease mealtime insulin dose by 50% to reduce the risk of hypoglycemia. Monitor blood glucose frequently and individualize further insulin dose adjustments based on glycemic control. Risk D: Consider therapy modification

Prothionamide: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Quinolones: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolones may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy

Ritodrine: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Rosiglitazone: Insulins may enhance the adverse/toxic effect of Rosiglitazone. Specifically, the risk of fluid retention, heart failure, and hypoglycemia may be increased with this combination. Risk X: Avoid combination

Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Sodium-Glucose Cotransporter 2 (SLGT2) Inhibitors: May enhance the hypoglycemic effect of Insulins. Management: Consider a decrease in insulin dose when initiating therapy with a sodium-glucose cotransporter 2 inhibitor and monitor patients for hypoglycemia. Risk D: Consider therapy modification

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Monitoring Parameters

Plasma glucose, electrolytes, HbA1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2018]), potassium (in patients at risk for hypokalemia); renal function; hepatic function; weight

Reference Range

Recommendations for glycemic control in nonpregnant adults with diabetes (ADA 2018):

HbA1c: <7% (a more aggressive [<6.5%] or less aggressive [<8%] HbA1c goal may be targeted based on patient-specific characteristics)

Preprandial capillary blood glucose: 80 to 130 mg/dL

Peak postprandial capillary blood glucose: <180 mg/dL

Recommendations for glycemic control in older adults (≥65 years of age) with diabetes (ADA 2018):

HbA1c: <7.5% (healthy); <8% (complex/intermediate health); <8.5% (very complex/poor health) (individualization may be appropriate based on patient and caregiver preferences)

Preprandial capillary blood glucose: 90 to 130 mg/dL (healthy); 90 to 150 mg/dL (complex/intermediate health); 100 to 180 mg/dL (very complex/poor health)

Bedtime capillary blood glucose: 90 to 150 mg/dL (healthy); 100 to 180 mg/dL (complex/intermediate health); 110 to 200 mg/dL (very complex/poor health)

Recommendations for glycemic control in pediatric (all age groups) patients with type 1 diabetes (ADA 2018):

HbA1c: <7.5% (individualization may be appropriate based on patient-specific characteristics; <7% is reasonable if it can be achieved without excessive hypoglycemia)

Preprandial capillary blood glucose: 90 to 130 mg/dL

Bedtime and overnight capillary blood glucose: 90 to 150 mg/dL

Recommendations for hospitalized adult patients with diabetes (ADA 2018): Target glucose range: 140 to 180 mg/dL (majority of critically ill and noncritically ill patients; <140 mg/dL may be appropriate for selected patients, if it can be achieved without excessive hypoglycemia). Initiate insulin therapy for persistent hyperglycemia at ≥180 mg/dL

Recommendations for perioperative care in adult patients with diabetes (ADA 2018): Target glucose range during perioperative period: Consider targeting 80 to 180 mg/dL

Advanced Practitioners Physical Assessment/Monitoring

Obtain HbA1c (at least twice annually if meeting goals and quarterly for patients not meeting treatment goals or with therapy change), serum glucose, electrolytes, potassium, renal function tests, and liver function tests. Monitor weight. Monitor for hypoglycemia at regular intervals during therapy. Teach patient proper use, including appropriate injection technique and syringe/needle disposal, and monitoring requirements. Refer to dietician and/or diabetes self-management education.

Nursing Physical Assessment/Monitoring

Check ordered labs and report abnormalities. Monitor for hypoglycemia at regular intervals during therapy. Teach patient proper use, including appropriate injection technique and syringe/needle disposal, and monitoring requirements. Educate and instruct patient to report signs of hypoglycemia (dizziness, headache, fatigue, weakness, shaking, fast heartbeat, confusion, hunger, or sweating) or hypokalemia (muscle pain or weakness, muscle cramps, or an abnormal heartbeat). May need referral to dietician and/or diabetes self-management education.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous:

Lantus: 100 units/mL (10 mL) [contains metacresol]

Solution Pen-injector, Subcutaneous:

Basaglar KwikPen: 100 units/mL (3 mL) [contains metacresol]

Lantus SoloStar: 100 units/mL (3 mL) [contains metacresol]

Toujeo Max SoloStar: 300 units/mL (3 mL) [contains metacresol]

Toujeo SoloStar: 300 units/mL (1.5 mL) [contains metacresol]

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous:

Lantus: 100 units/mL (3ml, 10ml) [contains CRESOL]

Solution Cartridge, Subcutaneous:

Basaglar: 100 units/mL (3ml) [contains METACRESOL]

Lantus: 100 units/mL (3ml)

Solution Pen-injector, Subcutaneous:

Basaglar KwikPen: 100 units/mL (3ml) [contains METACRESOL]

Lantus SoloStar: 100 units/mL (3ml)

Toujeo SoloStar: 300 units/mL (1.5ml) [contains METACRESOL]

Anatomic Therapeutic Chemical (ATC) Classification
  • A10AE04
Generic Available (US)

No

Pricing: US

Solution (Lantus Subcutaneous)

100 units/mL (per mL): $34.03

Solution Pen-injector (Basaglar KwikPen Subcutaneous)

100 units/mL (per mL): $26.11

Solution Pen-injector (Lantus SoloStar Subcutaneous)

100 units/mL (per mL): $34.02

Solution Pen-injector (Toujeo Max SoloStar Subcutaneous)

300 units/mL (per mL): $103.66

Solution Pen-injector (Toujeo SoloStar Subcutaneous)

300 units/mL (per mL): $103.65

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

Insulin acts via specific membrane-bound receptors on target tissues to regulate metabolism of carbohydrate, protein, and fats. Target organs for insulin include the liver, skeletal muscle, and adipose tissue.

Within the liver, insulin stimulates hepatic glycogen synthesis. Insulin promotes hepatic synthesis of fatty acids, which are released into the circulation as lipoproteins. Skeletal muscle effects of insulin include increased protein synthesis and increased glycogen synthesis. Within adipose tissue, insulin stimulates the processing of circulating lipoproteins to provide free fatty acids, facilitating triglyceride synthesis and storage by adipocytes; also directly inhibits the hydrolysis of triglycerides. In addition, insulin stimulates the cellular uptake of amino acids and increases cellular permeability to several ions, including potassium, magnesium, and phosphate. By activating sodium-potassium ATPases, insulin promotes the intracellular movement of potassium.

Normally secreted by the pancreas, insulin products are manufactured for pharmacologic use through recombinant DNA technology using either E. coli or Saccharomyces cerevisiae. Insulin glargine differs from human insulin by adding two arginines to the C-terminus of the B-chain in addition to containing glycine at position A21 in comparison to the asparagine found in human insulin. Insulins are categorized based on the onset, peak, and duration of effect (eg, rapid-, short-, intermediate-, and long-acting insulin). Insulin glargine is a long-acting insulin analog.

Pharmacodynamics/Kinetics

Note: Onset and duration of hypoglycemic effects depend upon the route of administration (absorption and onset of action are more rapid after deeper IM injections than after SubQ), site of injection (onset and duration are progressively slower with SubQ injection into the abdomen, arm, buttock, or thigh respectively), volume and concentration of injection, and the preparation administered. Rate of absorption, onset, and duration of activity may be affected by exercise, presence of lipodystrophy, local blood supply, and/or temperature.

Onset of action: Lantus: 3 to 4 hours; Toujeo: 6 hours

Peak effect: Lantus, Basaglar: No pronounced peak; Toujeo: Maximum glucose lowering effect may take up to 5 days with repeat dosing; at steady state, the 24-hour glucose lowering effect is ~27% lower than that of Lantus at equivalent doses.

Duration: Lantus, Basaglar: Generally 24 hours or longer; reported range (Lantus): 10.8 to >24 hours (up to ~30 hours documented in some studies) (Heinemann 2000); Toujeo: >24 hours

Absorption: Slow; upon injection into the subcutaneous tissue, microprecipitates form which allow small amounts of insulin glargine to release over time

Metabolism: Partially metabolized in the subcutaneous depot at the carboxyl terminus of the B chain to form two active metabolites, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin)

Time to peak, plasma: Lantus: No pronounced peak; Basaglar: ~12 hours; Toujeo: median of 12 to 16 hours (dose dependent)

Excretion: Urine

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: Insulin Cl may be reduced in patients with impaired renal function.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: In general, morning appointments are advisable in patients with diabetes since endogenous cortisol levels are typically higher at this time; because cortisol increases blood sugar levels, the risk of hypoglycemia is less. It is important to confirm that the patient has eaten normally prior to the appointment and has taken all scheduled medications. If a procedure is planned with the expectation that the patient will alter normal eating habits ahead of time (eg, conscious sedation), diabetes medication dose may need to be modified in consultation with the patient’s physician. Patients with well-controlled diabetes can usually be managed conventionally for most surgical procedures. Although patients with diabetes usually recognize signs and symptoms of hypoglycemia and self-intervene before changes in or loss of consciousness occurs, they may not. Staff should be trained to recognize the signs (eg, unusual behavior or profuse sweating in patients who have diabetes) and treat patients who have hypoglycemia; a glucometer should be used to test patient blood glucose levels. Every dental office should have a protocol for managing hypoglycemia in conscious and unconscious patients. Having snack foods or oral glucose tablets or gels available, especially in practices where a large number of surgical procedures are performed, is also prudent (American Diabetes Association 2017).

Effects on Bleeding

No information available to require special precautions

Index Terms

Glargine Insulin

FDA Approval Date
April 20, 2000
References

Alemzadeh R, Berhe T, Wyatt DT. Flexible insulin therapy with glargine insulin improved glycemic control and reduced severe hypoglycemia among preschool-aged children with type 1 diabetes mellitus. Pediatrics. 2005;115(5):1320-1324. doi: 10.1542/peds.2004-1439.[PubMed 15867042]

American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins, “Clinical Management Guidelines for Obstetrician-Gynecologists. Number 60, March 2005. Pregestational Diabetes Mellitus,” Obstet Gynecol, 2005, 105(3):675-85.[PubMed 15738045]

American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins—Obstetrics. ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018;131(2):e49-e64.[PubMed 29370047]

American Diabetes Association (ADA). Diabetes Care. 2018;41(suppl 1):S1-S159. Available at: http://care.diabetesjournals.org/content/41/Supplement_1. Accessed June 6, 2018.

Ashwell SG, Gebbie J, Home PD. Twice-daily compared with once-daily insulin glargine in people with Type 1 diabetes using meal-time insulin aspart. Diabet Med. 2006;23(8):879-886. doi: 10.1111/j.1464-5491.2006.01913.x.[PubMed 16911626]

Basaglar (insulin glargine) [prescribing information]. Indianapolis, IN: Lilly USA, LLC; September 2018.

Basaglar (insulin glargine). [product monograph]. Scarborough, Ontario, Canada: Eli Lilly Canada Inc; February 2017.

Beck JK, Cogen FR. Outpatient management of pediatric type 1 diabetes. J Pediatr Pharmacol Ther. 2015;20(5):344-357. doi: 10.5863/1551-6776-20.5.344.[PubMed 26472948]

Blumer I, Hadar E, Hadden DR, et al. Diabetes and pregnancy: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2013;98(11):4227-4249.[PubMed 24194617 ]

Centers for Disease Control and Prevention (CDC). CDC clinical reminder: insulin pens must never be used for more than one person. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/injectionsafety/clinical-reminders/insulin-pens.html. Updated January 5, 2012. Accessed January 9, 2012.

Chiang JL, Kirkman MS, Laffel LM, et al; Type 1 Diabetes Sourcebook Authors. Type 1 diabetes through the life span: a position statement of the American Diabetes Association. Diabetes Care. 2014;37(7):2034-54. doi: 10.2337/dc14-1140.[PubMed 24935775]

Colino E, López-Capapé M, Golmayo L, et al. Therapy with insulin glargine (Lantus) in toddlers, children and adolescents with type 1 diabetes. Diabetes Res Clin Pract. 2005;70(1):1-7. doi: 10.1016/j.diabres.2005.02.004.[PubMed 16126116]

Copeland KC, Silverstein J, Moore KR, et al; American Academy of Pediatrics. Management of newly diagnosed type 2 diabetes mellitus (T2DM) in children and adolescents. Pediatrics. 2013;131(2):364-382. doi: 10.1542/peds.2012-3494.[PubMed 23359574]

Danne T, Phillip M, Buckingham BA, et al. ISPAD Clinical Practice Consensus Guidelines 2018: Insulin treatment in children and adolescents with diabetes. Pediatr Diabetes. 2018;19(suppl 27):115-135. doi: 10.1111/pedi.12718.[PubMed 29999222]

Davies MJ, D’Alessio DA, Fradkin J, et al. Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) [published online October 4, 2018]. Diabetes Care. 2018. pii: dci180033. doi: 10.2337/dci18-0033.[PubMed 30291106]

Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2018 executive summary. Endocr Pract. 2018;24(1):91-120. doi: 10.4158/CS-2017-0153.[PubMed 29368965]

Handelsman Y, Bloomgarden ZT, Grunberger G, et al. American Association of Clinical Endocrinologists and American College of Endocrinology – clinical practice guidelines for developing a diabetes mellitus comprehensive care plan – 2015. Endocr Pract. 2015;21 Suppl 1:1-87. doi: 10.4158/EP15672.GL.[PubMed 25869408]

Heinemann L, Hompesch B, Linkeschova R, et al, “Time-Action Profile of the Long-Acting Insulin Analog Insulin Glargine (HOE901) in Comparison With Those of NPH and Placebo,” Diabetes Care, 2000, 23(5):644-9.[PubMed 10834424]

International Diabetes Federation, International Society for Pediatric and Adolescent Diabetes. Global IDF/ISPAD Guideline for Diabetes in Childhood and Adolescence. 2011. Available at http://www.idf.org/global-idfispad-guideline-diabetes-childhood-and-adolescence. Last accessed: October 21, 2013.

Jefferies C, Rhodes E, Rachmiel M, et al. ISPAD Clinical Practice Consensus Guidelines 2018: Management of children and adolescents with diabetes requiring surgery. Pediatr Diabetes. 2018;19(suppl 27):227-236. doi: 10.1111/pedi.12733.[PubMed 30039617]

Jovanovic L, Pettitt DJ. Treatment with insulin and its analogs in pregnancies complicated by diabetes. Diabetes Care. 2007;30(Suppl 2):S220-224.[PubMed 17596476 ]

Kirkman M, Briscoe VJ, Clark N, et al, “Diabetes in Older Adults: A Consensus Report,” J Am Geriatr Soc, 2012; doi: 10.1111/jgs.12035.[PubMed 23106132]

Lambert K, Holt RI. The use of insulin analogues in pregnancy. Diabetes Obes Metab. 2013;15(10):888-900.[PubMed 23489521 ]

Lantus (insulin glargine) [prescribing information]. Bridgewater, NJ: Sanofi-Aventis; November 2018.

Lantus (insulin glargine) [product monograph]. Laval, Quebec, Canada: Sanofi-Aventis Canada Inc; October 2017.

Lepercq J, Lin J, Hall GC, et al. Meta-analysis of maternal and neonatal outcomes associated with the use of insulin glargine versus NPH insulin during pregnancy. Obstet Gynecol Int. 2012;2012:649070.[PubMed 22685467]

Lipska KJ, Hirsch IB, Riddle MC. Human insulin for type 2 diabetes: an effective, less-expensive option. JAMA. 2017;318(1):23-24. doi: 10.1001/jama.2017.6939.[PubMed 28604935]

Lipska KJ, Parker MM, Moffet HH, et al. Association of initiation of basal insulin analogs vs neutral protamine hagedorn insulin with hypoglycemia-related emergency department visits or hospital admissions and with glycemic control in patients with type 2 diabetes. JAMA. 2018;320(1):53-62. doi: 10.1001/jama.2018.7993.[PubMed 29936529]

McCall AL. Insulin therapy and hypoglycemia. Endocrinol Metab Clin North Am. 2012;41(1):57-87. doi: 10.1016/j.ecl.2012.03.001.[PubMed 22575407]

Metzger BE, Buchanan TA, Coustan DR, et al, “Summary and Recommendations of the Fifth International Workshop-Conference on Gestational Diabetes Mellitus,” Diabetes Care, 2007, 30(Suppl 2):251-60.[PubMed 17596481]

Peters AP, Laffel L, eds. Type 1 Diabetes Sourcebook. Alexandria, VA: American Diabetes Association; 2013.

Pollex E, Moretti ME, Koren G, Feig DS. Safety of insulin glargine use in pregnancy: a systematic review and meta-analysis. Ann Pharmacother. 2011;45(1):9-16.[PubMed 21205954]

Reader D, Franz MJ. Lactation, diabetes, and nutrition recommendations. Curr Diab Rep. 2004;4(5):370-376.[PubMed 15461903 ]

Rosenstock J, Dailey G, Massi-Benedetti M, et al. Reduced hypoglycemia risk with insulin glargine: a meta-analysis comparing insulin glargine with human NPH insulin in type 2 diabetes. Diabetes Care. 2005;28(4):950-955.[PubMed 15793205]

Rys P, Wojciechowski P, Rogoz-Sitek A, et al. Systematic review and meta-analysis of randomized clinical trials comparing efficacy and safety outcomes of insulin glargine with NPH insulin, premixed insulin preparations or with insulin detemir in type 2 diabetes mellitus. Acta Diabetol. 2015;52(4):649-662. doi: 10.1007/s00592-014-0698-4.[PubMed 25585592]

Silverstein J, Klingensmith G, Copeland K, et al; American Diabetes Association. Care of children and adolescents with type 1 diabetes: a statement of the American Diabetes Association. Diabetes Care. 2005;28(1):186-212.[PubMed 15616254]

Singh SR, Ahmad F, Lal A, et al. Efficacy and safety of insulin analogues for the management of diabetes mellitus: a meta-analysis. CMAJ. 2009;180(4):385-397. doi: 10.1503/cmaj.081041.[PubMed 19221352]

Sundberg F, Barnard K, Cato A, et al. ISPAD Guidelines. Managing diabetes in preschool children. Pediatr Diabetes. 2017;18(7):499-517. doi: 10.1111/pedi.12554.[PubMed 28726299]

Toujeo (insulin glargine) [prescribing information]. Bridgewater, NJ: Sanofi-Aventis; October 2018.

Toujeo SoloStar (insulin glargine) [product monograph]. Laval, Quebec, Canada: Sanofi-Aventis Canada Inc; July 2018.

Whitmore TJ, Trengove NJ, Graham DF, Hartmann PE. Analysis of insulin in human breast milk in mothers with type 1 and type 2 diabetes mellitus. Int J Endocrinol. 2012;2012:296368.[PubMed 22500167 ]

Youssef D, El Abbassi A, Woodby G, et al. Benefits of twice-daily injection with insulin glargine: a case report and review of the literature. Tenn Med. 2010;103(2):42-43.[PubMed 20345066]

Zeitler P, Arslanian S, Fu J, Pinhas-Hamiel O, et al. ISPAD Clinical Practice Consensus Guidelines 2018: Type 2 diabetes mellitus in youth. Pediatr Diabetes. 2018;19(suppl 27):28-46. doi: 10.1111/pedi.12719.[PubMed 29999228]

Brand Names: International

Abasaglar (BE, DK, EE, ES, GB, HR, LT, NL, NO, PL, PT, RO, SK); Abasria (MT); Basagine (PH); Basaglar (ID, SG); Basaglar KwikPen (PH); Basalog (MY); Basalog One (MY); Bonglixan (CR, DO, GT, HN, MX, NI, PA, SV); Endulin (ZW); Ezelin (ID); Glargilin (PH); Glaritus (PH, VN); Glysolin G (PH); Insulet GN (BD); Lantus (AE, AR, AT, AU, BB, BE, BG, BH, BM, BR, BS, BZ, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IN, IS, IT, JM, JO, KR, KW, LB, LK, LT, LU, LV, MT, MX, MY, NI, NL, NO, NZ, PA, PE, PH, PK, PL, PR, PT, PY, QA, RO, RU, SA, SE, SG, SI, SK, SR, SV, TH, TR, TT, TW, UA, UY, VE, VN, ZW); Lantus XR (JP); Lusduna (BE); Optisulin (CZ, EE, FI, IE, IN, LT, MT, NL, PL, PT, RO); Podevta (PH); Sansulin Log-G (ID); Toujeo (BE, BH, SG, UA); Tuojeo (GB, HK, HR, IE, MY, NL, PH, SK, TH, VN); Vibrenta (BD)

Insulin Glargine (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

(IN soo lin GLAR jeen)

Brand Names: US

Basaglar KwikPen; Lantus; Lantus SoloStar; Toujeo Max SoloStar; Toujeo SoloStar

Brand Names: Canada

Basaglar; Lantus; Toujeo SoloStar

What is this drug used for?
  • It is used to lower blood sugar in patients with high blood sugar (diabetes).
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to insulin 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 have any of these health problems: Acidic blood problem or low blood sugar.
  • 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.
  • Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
  • Low blood sugar may happen with this drug. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death. Talk with the doctor.
  • Low blood potassium may happen with this drug. If not treated, this can lead to a heartbeat that is not normal, very bad breathing problems, and sometimes death. Talk with the doctor.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • Some diabetes drugs like pioglitazone or rosiglitazone may cause heart failure or make it worse in people who already have it. Using insulin with these drugs may increase this risk. If you also take one of these drugs, talk with the doctor.
  • Be sure you have the right insulin product. Insulin products come in many containers like vials, cartridges, and pens. Be sure that you know how to measure and get your dose ready. If you have any questions, call your doctor or pharmacist.
  • It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
  • Wear disease medical alert ID (identification).
  • Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
  • Check your blood sugar as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Talk with your doctor before you drink alcohol or take products that have alcohol in them.
  • Do not switch between different brands of this drug without first talking with the doctor.
  • Do not share your insulin product with another person. This includes any pens, cartridge devices, needles, or syringes, even if the needle has been changed. Sharing may pass infections from one person to another. This includes infections you may not know you have.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
  • U-300 prefilled pens:
  • This brand of insulin has 3 times as much insulin as other brands. It comes in a prefilled pen that you must use to take your dose. Do not use a syringe to remove insulin from the pen. Doing so may lead to very bad side effects or life-threatening low blood sugar. Be sure to use the right dose of this drug. Talk with the 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:
  • 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 low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Change in eyesight.
  • Very bad dizziness or passing out.
  • Very bad headache.
  • Seizures.
  • Change in skin to thick or thin where the shot was given.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Low mood (depression).
  • Low blood sugar may occur. Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if any of these signs occur. Follow what you have been told to do if low blood sugar occurs. This may include taking glucose tablets, liquid glucose, or some fruit juices.
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:
  • Irritation where the shot is given.
  • Back pain.
  • Diarrhea.
  • Headache.
  • Weight gain.
  • Nose or throat irritation.
  • 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.
  • All products:
  • It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
  • 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.
  • Take this drug at the same time of day.
  • Move site where you give the shot each time.
  • 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.
  • Do not use if 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.
  • Do not use outdated insulin.
  • Do not mix this insulin in the same syringe with other types of insulin.
  • Do not mix with other liquids.
  • Follow the diet and workout plan that your doctor told you about.
  • This drug must not be used in an insulin pump. If you have questions, talk with the doctor.
  • Vials:
  • Do not draw into a syringe and store for future use.
  • Cartridges and prefilled pens:
  • Remove all pen needle covers before injecting a dose (there may be 2). If you are not sure what type of pen needle you have or how to use it, talk with the doctor.
  • Do not move this drug from the pen to a syringe.
  • This product may make a clicking sound as you prepare the dose. Do not prepare the dose by counting the clicks. Doing so could lead to using the wrong dose.
  • Take off the needle after each shot. Do not store this device with the needle on it.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next shot, skip the missed shot and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • If you are not sure what to do if you miss a dose, call your doctor.
How do I store and/or throw out this drug?
  • Vials:
  • Store unopened vials in a refrigerator. Do not freeze.
  • If an unopened container has been stored at room temperature, be sure you know how long you can leave this drug at room temperature before you need to throw it away. If you are not sure, talk with the doctor or pharmacist.
  • After opening, store in the refrigerator or at room temperature. Throw away any part not used after 28 days.
  • U-100 cartridges and pens:
  • Store unopened containers in a refrigerator. Do not freeze.
  • If an unopened container has been stored at room temperature, be sure you know how long you can leave this drug at room temperature before you need to throw it away. If you are not sure, talk with the doctor or pharmacist.
  • Store opened cartridges and pens at room temperature. Throw away any part not used after 28 days.
  • U-300 prefilled pens:
  • Store unopened pens in a refrigerator. Do not freeze.
  • Store opened pens at room temperature. Do not refrigerate. Throw away any part not used after 56 days.
  • All products:
  • Do not use if it has been frozen.
  • Protect from heat and light.
  • 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.
Insulin Glargine (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

(IN soo lin GLAR jeen)

Brand Names: US

Basaglar KwikPen; Lantus; Lantus SoloStar; Toujeo Max SoloStar; Toujeo SoloStar

Brand Names: Canada

Basaglar; Lantus; Toujeo SoloStar

What is this drug used for?
  • It is used to lower blood sugar in patients with high blood sugar (diabetes).
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 has any of these health problems: Acidic blood problem or low blood sugar.
  • 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?
  • All products:
  • 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.
  • Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
  • Low blood sugar may happen with this drug. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death. Talk with the doctor.
  • Low blood potassium may happen with this drug. If not treated, this can lead to a heartbeat that is not normal, very bad breathing problems, and sometimes death. Talk with the doctor.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • Some diabetes drugs like pioglitazone or rosiglitazone may cause heart failure or make it worse in people who already have it. Using insulin with these drugs may increase this risk. If you also take one of these drugs, talk with the doctor.
  • Be sure your child has the right insulin product. Insulin products come in many containers like vials, cartridges, and pens. Be sure that you know how to measure and get your child’s dose ready. If you have any questions, call the doctor or pharmacist.
  • It may be harder to control your child’s blood sugar during times of stress like when your child has a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your child’s blood sugar. Talk with the doctor.
  • Have your child wear disease medical alert ID (identification).
  • If your child can drive, do not let your child drive if his/her blood sugar has been low. There is a greater chance of a crash.
  • Have your child’s blood sugar checked as you have been told by your child’s doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Alcohol interacts with this drug. Be sure your child does not drink alcohol or take products that have alcohol in them.
  • Do not switch between different brands of this drug without first talking with the doctor.
  • Do not share your child’s insulin product with another person. This includes any pens, cartridge devices, needles, or syringes, even if the needle has been changed. Sharing may pass infections from one person to another. This includes infections you may not know your child has.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
  • U-300 prefilled pens:
  • This brand of insulin has 3 times as much insulin as other brands. It comes in a prefilled pen that you must use to give your child’s dose. Do not use a syringe to remove insulin from the pen. Doing so may lead to very bad side effects or life-threatening low blood sugar. Be sure to give your child the right dose of this drug. 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 low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Change in eyesight.
  • Very bad dizziness or passing out.
  • Very bad headache.
  • Seizures.
  • Change in skin to thick or thin where the shot was given.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Low mood (depression).
  • Low blood sugar can happen. The chance of low blood sugar may be raised when this drug is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if your child has any of these signs. Follow what you have been told to do if your child gets low blood sugar. This may include giving your child glucose tablets, liquid glucose, or some fruit juices.
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:
  • Irritation where the shot is given.
  • Back pain.
  • Diarrhea.
  • Headache.
  • Weight gain.
  • Nose or throat irritation.
  • 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.
  • All products:
  • It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
  • 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.
  • Do not give outdated insulin.
  • Do not mix this insulin in the same syringe with other types of insulin.
  • Do not mix with other liquids.
  • Give this drug at the same time of day.
  • Move site where you give the shot each time.
  • 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.
  • Do not use if 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.
  • Have your child follow the diet and workout plan your child’s doctor told you about.
  • This drug must not be used in an insulin pump. If you have questions, talk with the doctor.
  • Vials:
  • Do not draw into a syringe and store for future use.
  • Cartridges and prefilled pens:
  • Remove all pen needle covers before injecting a dose (there may be 2). If you are not sure what type of pen needle you have or how to use it, talk with the doctor.
  • Do not move this drug from the pen to a syringe.
  • This product may make a clicking sound as you prepare the dose. Do not prepare the dose by counting the clicks. Doing so could lead to using the wrong dose.
  • Take off the needle after each shot. Do not store this device with the needle on it.
What do I do if my child misses a dose?
  • Give a missed shot as soon as you think about it.
  • If it is close to the time for your child’s next shot, skip the missed shot and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • If you are not sure what to do if you miss giving your child a dose, call the doctor.
How do I store and/or throw out this drug?
  • Vials:
  • Store unopened vials in a refrigerator. Do not freeze.
  • If an unopened container has been stored at room temperature, be sure you know how long you can leave this drug at room temperature before you need to throw it away. If you are not sure, talk with the doctor or pharmacist.
  • After opening, store in the refrigerator or at room temperature. Throw away any part not used after 28 days.
  • U-100 cartridges and pens:
  • Store unopened containers in a refrigerator. Do not freeze.
  • If an unopened container has been stored at room temperature, be sure you know how long you can leave this drug at room temperature before you need to throw it away. If you are not sure, talk with the doctor or pharmacist.
  • Store opened cartridges and pens at room temperature. Throw away any part not used after 28 days.
  • U-300 prefilled pens:
  • Store unopened pens in a refrigerator. Do not freeze.
  • Store opened pens at room temperature. Do not refrigerate. Throw away any part not used after 56 days.
  • All products:
  • Do not use if it has been frozen.
  • Protect from heat and light.
  • 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.