Insulin Detemir (Lexi-Drugs)

Pronunciation

(IN soo lin DE te mir)

Brand Names: US

Levemir; Levemir FlexTouch

Brand Names: Canada

Levemir FlexTouch; Levemir Penfill

Pharmacologic Category

Insulin, Long-Acting

Dosing: Adult

Note: Insulin detemir 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 detemir 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 detemir may be administered as a single dose or in two divided doses daily.

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. Treatment and monitoring regimens must be individualized. To minimize hypoglycemia risk, basal insulins are generally titrated once or twice weekly (eg, every 3 to 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]).

Patients inadequately controlled on oral antidiabetic agents: Initial: 10 units (or 0.1 to 0.2 units/kg) once daily in the evening or in 2 divided doses (ADA 2018; manufacturer’s labeling). If HbA1c >8% prior to initiation of basal insulin, 0.2 to 0.3 units/kg/day is recommended (AACE/ACE [Garber 2018]).

Patients inadequately controlled on GLP-1 receptor agonist: Initial: 10 units once daily in the evening (manufacturer’s labeling).

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 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 detemir; if basal insulin naive, administer insulin detemir 5 units every 12 hours.

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, detemir, glargine, or degludec) (ADA 2018)

Conversion from insulin glargine or NPH insulin to insulin detemir: Initial: May be substituted on an equivalent unit-per-unit basis; some patients with Type 2 diabetes may require higher doses of detemir than NPH.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Pediatric

Note: Insulin detemir is a long-acting insulin administered by SubQ injection. When compared to insulin NPH, insulin detemir has slower, more prolonged absorption; duration of activity is dose-dependent. Insulin detemir may be given once or twice daily when used as the basal insulin component of therapy. Changing the basal insulin component from another insulin to insulin detemir can be done on a unit-to-unit basis. Insulin requirements vary dramatically between patients and dictate frequent monitoring and close medical supervision. See Insulin Regular for additional information.

General insulin dosing: Type 1 diabetes mellitus (DM): Infants, Children, and Adolescents: Note: Insulin regimens should be individualized to achieve glycemic goals without causing hypoglycemia. Multiple daily doses are utilized and guided by blood glucose monitoring. Combinations of insulin formulations are commonly used. The daily doses presented below are expressed as the total units/kg/day of all insulin formulations combined.

Usual maintenance range: SubQ: 0.5 to 1 unit/kg/day in divided doses; doses must be individualized; however, an estimate can be determined based on phase of diabetes and level of maturity (ISPAD [Couper 2014]; ISPAD [Danne 2014]).

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

Prepubertal children (not in partial remission): 0.7 to 1 units/kg/day

Pubescent Children and Adolescents: During puberty, requirements may substantially increase to >1.2 unit/kg/day and in some cases up to 2 units/kg/day

Adjustment of dose: 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.

Insulin detemir-specific dosing:

Type 1 diabetes mellitus: Children ≥2 years and Adolescents: SubQ: Initial dose: Approximately one-third of the total daily insulin requirement; a rapid-acting or short-acting insulin should also be used. If administered once daily, doses are generally administered with evening meals or at bedtime.

Conversion from insulin glargine or NPH insulin: SubQ: May be substituted on an equivalent unit-per-unit basis; in one Type 2 diabetes clinical trial, higher doses of insulin detemir were required than insulin NPH.

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: Treatment of type 1 diabetes mellitus and type 2 diabetes mellitus to improve glycemic control

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 administer IM or IV; for SubQ administration only. Do not use if solution is viscous or cloudy; use only if clear and colorless with no visible particles. Insulin detemir should be administered once or twice daily. When given once daily, administer with the evening meal or at bedtime. When given twice daily, administer the evening dose with the evening meal, at bedtime, or 12 hours following the morning dose. SubQ administration is usually made into the thighs, upper arms, 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 detemir with any other insulin formulation or solution; not recommended for use in external SubQ insulin infusion pump. For Levemir FlexTouch pen, prime the needle before each injection with 2 units of insulin (use a new needle for each injection). Once injected, hold the pen device in the skin for a count of 6 after the dose dial has returned to 0 units before removing the needle to ensure the full dose has been administered.

Administration: Pediatric

Parenteral: SubQ: Administer into the thighs, deltoids, or abdomen, with sites rotated. Cold injections should be avoided. Not for IV infusion or use in insulin infusion pumps. Do not use if solution is viscous or cloudy; use only if clear and colorless with no visible particles. May not be diluted or mixed with other insulins or solutions. When treated once daily, administer with evening meal or at bedtime. When treated twice daily, administer evening dose with evening meal, at bedtime, or 12 hours following the morning dose.

Dietary Considerations

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

Storage/Stability

Unopened vials, cartridges, and prefilled pens may be stored under refrigeration between 2°C and 8°C (36°F to 46°F) until the expiration date or at room temperature <30°C (<86°F) for 42 days; do not freeze; keep away from heat and sunlight. Once punctured (in use), vials may be stored under refrigeration or at room temperature <30°C (<86°F); use within 42 days. Cartridges and prefilled pens that have been punctured (in use) should be stored at temperatures <30°C (<86°F) and used within 42 days; do not freeze or refrigerate.

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 common cold symptoms, pharyngitis, flu-like symptoms, headache, abdominal pain, nausea, vomiting, or back pain. Have patient report immediately to prescriber signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), severe injection site irritation, blurred vision, chills, severe dizziness, passing out, mood changes, seizures, slurred speech, shortness of breath, excessive weight gain, swelling of arms or legs, or injection site change in skin to thick or thin (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:
Contraindications

Hypersensitivity to insulin detemir or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Allergic reactions, including anaphylaxis, may occur with insulin products.

• 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 with 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 with glargine/detemir when treating to conventional targets in a real world setting (Lipska 2018).

• 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 (DKA): Should not be used in patients with 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 detemir, although a clear solution, is NOT intended for IV or IM administration.

• Dosage adjustments: The duration of action of insulin detemir is dose-dependent; consider this factor during dosage adjustment and titration.

• 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% to 8.5% is acceptable for elderly patients, depending on the level of comorbidities, functional and cognitive status, and living situation (eg, caregiver present to assist, long-term care facility) (ADA 2018b). Depending on the living situation and who is giving the injection, assessment of the correct use of prefilled pen devices should be performed. The strength, dexterity, and multistep nature of the use of this type of device can make it difficult for some older adult patients. 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 (ADA 2018b).

Insulin has been implicated as a major cause of adverse effects requiring hospitalization, especially in those ≥80 years of age (Budnitz 2011). Care should be taken to ensure appropriate monitoring is undertaken when initiating or titrating insulin in an older adult. Insulin detemir, or any long-acting insulin, can be considered a good option in the older adult, as it is associated with less hypoglycemia than basal-bolus or short-acting insulin regimens. However, insulin detemir can result in more hypoglycemia in an older adult population than that seen in a younger adult population (Karnieli 2013).

Pregnancy Risk Factor

B

Pregnancy Considerations

Insulin detemir has been detected in cord blood. An increased risk of fetal abnormalities has not been observed following the use of insulin detemir in pregnancy; pregnancy outcomes are similar following maternal use of insulin detemir and NPH insulin.

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 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). 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). Women who are stable on insulin detemir prior to conception may continue it during pregnancy. Pregnant women may also be switched to insulin detemir during pregnancy when therapy with NPH insulin is not adequate (Blumer 2013).

Breast-Feeding Considerations

Both exogenous and endogenous insulin are present in breast milk (study not conducted with this preparation) (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 recommends that caution be used in breastfeeding women; adjustments of the mother’s insulin dose may be needed.

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

>10%:

Central nervous system: Headache (adults: 7% to 23%, children: 31%)

Endocrine & metabolic: Hypoglycemia (Type 1 combination regimens: children & adolescents: 93% to 95%, adults: 82% to 88%; Type 2 combination regimens: adults: 9% to 41%), severe hypoglycemia (Type 1 combination regimens: children & adolescents: 2% to 16%; adults 5% to 9%; Type 2 combination regimens: adults: ≤2%)

Gastrointestinal: Gastroenteritis (children & adolescents: 17%), abdominal pain (6%; children & adolescents: 13%)

Respiratory: Upper respiratory tract infection (13% to 26%; children & adolescents: 36%), pharyngitis (10%; children & adolescents: 17%), flu-like symptoms (8%; children & adolescents: 14%)

1% to 10%:

Gastrointestinal: Nausea (children & adolescents: 7%), vomiting (children & adolescents: 7%)

Infection: Viral infection (children & adolescents: 7%)

Respiratory: Cough (children & adolescents: 8%), rhinitis (children & adolescents: 7%)

Miscellaneous: Fever (children & adolescents: 10%)

<1%, postmarketing, and/or case reports: Pain at injection site

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

Diabetes mellitus: 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 2017c]), lipid profile, 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) 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 serum glucose, electrolytes, HbA1c (at least twice yearly in patients meeting goals and quarterly in patient not meeting goals), weight, lipid profile, renal function tests, and liver function tests. Assess for signs of hypoglycemia. 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).

Dosage Forms: US

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

Solution, Subcutaneous:

Levemir: 100 units/mL (10 mL) [contains metacresol, phenol]

Solution Pen-injector, Subcutaneous:

Levemir FlexTouch: 100 units/mL (3 mL) [contains metacresol, phenol]

Dosage Forms: Canada

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

Solution Cartridge, Subcutaneous:

Levemir Penfill: 100 units/mL (3ml) [contains METACRESOL, PHENOL]

Solution Pen-injector, Subcutaneous:

Levemir FlexTouch: 100 units/mL (3ml) [contains METACRESOL, PHENOL]

Anatomic Therapeutic Chemical (ATC) Classification
  • A10AE05
Generic Available (US)

No

Pricing: US

Solution (Levemir Subcutaneous)

100 units/mL (per mL): $36.98

Solution Pen-injector (Levemir FlexTouch Subcutaneous)

100 units/mL (per mL): $36.98

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 detemir differs from human insulin by the omission of threonine in position B30 and the addition of a C14 fatty acid chain to the amino acid located at position B29. Insulins are categorized based on the onset, peak, and duration of effect (eg, rapid-, short-, intermediate-, and long-acting insulin).

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: 3 to 4 hours

Peak effect: 3 to 9 hours (Plank 2005)

Duration: Dose dependent: 6 to 23 hours; Note: At lower dosages (0.1 to 0.2 units/kg), mean duration is variable (5.7 to 12.1 hours). At 0.4 units/kg, the mean duration was 19.9 hours. At high dosages (≥0.8 units/kg) the duration is longer and less variable (mean of 22 to 23 hours) (Plank 2005).

Distribution: Vd: 0.1 L/kg

Protein binding: >98% (albumin)

Bioavailability: 60%

Half-life elimination: 5 to 7 hours (dose-dependent)

Time to peak, plasma: 6 to 8 hours

Excretion: Urine

Pharmacodynamics/Kinetics: Additional Considerations

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

Pediatric: AUC and Cmax were higher by 10% and 24%, respectively, in children (6 to 12 y of age) compared with adolescents and adults.

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

Detemir Insulin

FDA Approval Date
June 16, 2005
References

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.

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 ]

Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365:2002-2012.[PubMed 22111719]

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.

Couper JJ, Haller MJ, Ziegler AG, Knip M, Ludvigsson J, Craig ME. Phases of type 1 diabetes in children and adolescents. Pediatr Diabetes. 2014;15(suppl 20):18-25.[PubMed 25325095]

Danne T, Bangstad HJ, Deeb L, et al. Insulin treatment in children and adolescents with diabetes. Pediatr Diabetes. 2014;15(suppl 20):115-134.[PubMed 25182312]

Danne T, Lupke K, Walte K, et al, “Insulin Detemir is Characterized by a Consistent Pharmacokinetic Profile Across Age-Groups in Children, Adolescents, and Adults With Type 1 Diabetes,” Diabetes Care, 2003, 26(11):3087-92.[PubMed 14578244]

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). Diabetes Care. 2018;41(12):2669-2701. 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]

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/e-library/guidelines/80-the-global-idf-ispad-guidelines-for-diabetes-in-childhood-and-adolescence.html. Accessed: April 27 2017.[PubMed 25869408]

Karnieli E, Baeres FM, Dzida G, et al. Observational study of once-daily insulin detemir in people with type 2 diabetes aged 75 years or older: a sub-analysis of data from the Study of Once daily LeVEmir (SOLVE). Drug Aging. 2013;30(3):167-175.[PubMed 23371395]

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 ]

Levemir (insulin detemir) [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; January 2019.

Lipska KJ, Parker MM, Moffet HH, et a. 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]

Plank J, Bodenlenz M, Sinner F, et al, “A Double-Blind, Randomized, Dose-Response Study Investigating the Pharmacodynamic and Pharmacokinetic Properties of the Long-Acting Insulin Analog Detemir,” Diabetes Care, 2005, 28(5):1107-12.[PubMed 15855574]

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]

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]

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 ]

Brand Names: International

Insulina Levemir (AR); Levemir (AE, AT, AU, BB, BE, BG, BH, BR, CH, CL, CN, CR, CU, CY, CZ, DE, DK, DO, ES, FI, FR, GB, GR, GT, HN, HR, HU, ID, IE, IL, IS, IT, JO, JP, KR, KW, LB, LK, LT, LU, LV, MT, MX, MY, NI, NL, NO, PA, PE, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, TZ, UY, VN, ZW)

Insulin Detemir (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 DE te mir)

Brand Names: US

Levemir; Levemir FlexTouch

Brand Names: Canada

Levemir

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?
  • 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).
  • Follow the diet and workout plan that your doctor told you about.
  • 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.
  • Avoid drinking alcohol or taking products that have alcohol in them while taking this drug.
  • 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.
  • Use with care in children. Talk with the doctor.
  • 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.
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.
  • Very bad irritation where the shot was given.
  • Blurred eyesight.
  • Fever or chills.
  • Very bad dizziness or passing out.
  • Mood changes.
  • Seizures.
  • Slurred speech.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Change in skin to thick or thin where the shot was given.
  • 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.
  • Weight gain.
  • Signs of a common cold.
  • Throat irritation.
  • Flu-like signs.
  • Headache.
  • Belly pain.
  • Back pain.
  • Upset stomach or throwing up.
  • 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.
  • If you use this drug once a day, use with the evening meal or at bedtime.
  • If you use this drug twice a day, use the evening dose with the evening meal, at bedtime, or 12 hours after the morning dose.
  • Move site where you give the shot each time.
  • Do not give into red or irritated skin.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Do not shake.
  • Do not mix this insulin in the same syringe with other types of insulin.
  • Do not mix this drug with other drugs in the same syringe.
  • If needed, you may inject this drug and other drugs in the same area of the body, but not right next to each other.
  • 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.
  • 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.
  • 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.
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.
How do I store and/or throw out this drug?
  • All products:
  • Store unopened containers in a refrigerator. Do not freeze.
  • Do not use if it has been frozen.
  • 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.
  • 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.
  • Vials:
  • You may store opened vials at room temperature or in a refrigerator. Throw away any part not used after 42 days.
  • Cartridges and prefilled pens:
  • Store opened cartridges and pens at room temperature. Throw away any part not used after 42 days.
  • Take off the needle after each shot. Do not store this device with the needle on it.
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 Detemir (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 DE te mir)

Brand Names: US

Levemir; Levemir FlexTouch

Brand Names: Canada

Levemir

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?
  • 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).
  • Have your child follow the diet and workout plan your child’s doctor told you about.
  • 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 your child’s blood work checked often. Talk with your child’s doctor.
  • Alcohol interacts with this drug. Be sure your child does not drink alcohol or take products that have alcohol in them.
  • 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.
  • Use with care in children. Talk with the doctor.
  • 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.
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.
  • Very bad irritation where the shot was given.
  • Blurred eyesight.
  • Fever or chills.
  • Very bad dizziness or passing out.
  • Mood changes.
  • Seizures.
  • Slurred speech.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Change in skin to thick or thin where the shot was given.
  • 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.
  • Weight gain.
  • Signs of a common cold.
  • Throat irritation.
  • Flu-like signs.
  • Headache.
  • Belly pain.
  • Back pain.
  • Upset stomach or throwing up.
  • 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.
  • If your child uses this drug once a day, give with the evening meal or at bedtime.
  • If your child uses this drug twice a day, give the evening dose with the evening meal, at bedtime, or 12 hours after the morning dose.
  • Move site where you give the shot each time.
  • Do not give into red or irritated skin.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Do not shake.
  • Do not mix this insulin in the same syringe with other types of insulin.
  • Do not mix this drug with other drugs in the same syringe.
  • 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 give outdated insulin.
  • 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.
  • 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.
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.
How do I store and/or throw out this drug?
  • All products:
  • Store unopened containers in a refrigerator. Do not freeze.
  • Do not use if it has been frozen.
  • 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.
  • 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.
  • Vials:
  • You may store opened vials at room temperature or in a refrigerator. Throw away any part not used after 42 days.
  • Cartridges and prefilled pens:
  • Store opened cartridges and pens at room temperature. Throw away any part not used after 42 days.
  • Take off the needle after each shot. Do not store this device with the needle on it.
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.