Pediatric efficacy and safety for Levemir®

Tresiba® (insulin degludec injection) 100 U/mL, 200 U/mL

Another long-acting insulin from Novo Nordisk

Tresiba® is the only basal insulin indicated for type 1 and type 2 diabetes in children as young as 1 year of age.1

Consider Tresiba® »

Similar A1C values vs NPH insulin in patients aged 2 to 16 years2

See Important Safety Information below.
View Prescribing Information.

Tresiba® is not recommended for pediatric patients requiring less than 5 units.

Similar A1C values vs NPH insulin in patients aged 2 to 16 years2

See study design below.

Mean A1C values, measured over the 52-week period, for children and adolescents taking Levemir® and NPH insulin2

Mean A1C levels in patients aged 2 to 16 years taking Levemir® vs NPH insulin

aFrom an ANCOVA model adjusted for baseline value, country, pubertal status at baseline, and age (stratification factor).

See study design below.

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Safety results

Levemir® safety results

✔ Safety results

In the same study, children as young as 2 years of age with type 1 diabetes who received Levemir® had comparable hypoglycemic episodes vs children who received NPH insulin.2,b

  • Non-severe hypoglycemia (event/patient/year): Levemir® (56.1); NPH (70.7)
  • Severe hypoglycemia (event/patient/year): Levemir® (0.02); NPH (0.09)

bNon-severe hypoglycemia=asymptomatic events with PG <65 mg/dL as well as symptomatic events that were self-treated or treated by taking oral therapy provided by the caregiver. Severe hypoglycemia = event with semi-consciousness, unconsciousness, coma and/or convulsions in a child who could not assist in treatment and who may have required glucagon or IV glucose.

Study design2

In a 52-week, randomized, controlled, open-label study, 347 children and adolescents with type 1 diabetes were stratified according to age (2 to 5 years, n=82; 6 to 16 years, n=265) at randomization.

  • This study evaluated the safety and efficacy of Levemir® and NPH insulin as part of a basal-bolus regimen that included NovoLog® (insulin aspart injection) 100 U/mL before each meal
  • Patients were randomized to receive either Levemir® (n=177) or NPH insulin (n=170) once or twice daily according to their pretrial basal insulin dose regimen
  • Patients in the NPH insulin group had no change in FPG (baseline=141 mg/dL)
  • This study had comparable rates of hypoglycemia between Levemir® and NPH insulin
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Selected Important Safety Information for Levemir® (insulin detemir injection) 100 U/mL

Contraindications

  • Levemir® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Levemir® or any of its excipients. Reactions have included anaphylaxis.

Warnings and Precautions

  • Never Share a Levemir® FlexTouch® Pen, Needle, or Syringe Between Patients: Levemir® FlexTouch® prefilled pens must never be shared between patients, even if the needle is changed. Patients using Levemir® vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed.
  • Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin, including Levemir®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment.

Levemir® (insulin detemir injection) 100 U/mL Indications and Usage

  • Levemir® (insulin detemir injection) 100 U/mL is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

Limitations of Use

Levemir® is not recommended for the treatment of diabetic ketoacidosis.

Important Safety Information

Contraindications

  • Levemir® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Levemir® or any of its excipients. Reactions have included anaphylaxis.

Warnings and Precautions

  • Never Share a Levemir® FlexTouch® Pen, Needle, or Syringe Between Patients: Levemir® FlexTouch® prefilled pens must never be shared between patients, even if the needle is changed. Patients using Levemir® vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed.
  • Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin, including Levemir®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment
  • Hypoglycemia Due to Medication Errors: Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between Levemir® and other insulins, instruct patients to always check the insulin label before each injection.
  • Hypersensitivity and Allergic Reactions: If hypersensitivity reactions occur, discontinue Levemir®; treat per standard of care and monitor until symptoms and signs resolve. Levemir® is contraindicated in patients who have had hypersensitivity reactions to insulin detemir or any of the excipients.
  • Hypokalemia: All insulin products, including Levemir®, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).
  • Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Levemir®, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

Adverse Reactions

  • Adverse reactions associated with Levemir® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash, pruritus.

Drug Interactions

  • Drugs that increase hypoglycemia risk or increase or decrease blood glucose lowering effect: adjustment of dosage may be needed; closely monitor blood glucose.
  • Drugs that blunt hypoglycemia signs and symptoms (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Increased frequency of glucose monitoring may be required.

Use in Specific Populations

  • Pregnancy: Available data from published studies and postmarketing case reports with Levemir® use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
    • Clinical Considerations - Disease-Associated Maternal and/or Embryo/Fetal Risk: Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.

Please click here for Levemir® Prescribing Information.

 

 

Tresiba® (insulin degludec injection) Indications and Usage

Tresiba® (insulin degludec injection) is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

Limitations of Use

Tresiba® is not recommended for treating diabetic ketoacidosis.

Important Safety Information

Contraindications

  • Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients

Warnings and Precautions

  • Never Share a Tresiba® FlexTouch® Pen, Needle, or Syringe Between Patients, even if the needle is changed. Patients using Tresiba® vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed.
  • Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment
  • Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors, always instruct patients to check the insulin label before each injection
  • Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Tresiba®
  • As with all insulins, Tresiba® use can lead to life-threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated
  • Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Tresiba®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered

Adverse Reactions

  • Adverse reactions commonly associated with Tresiba® are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain

Drug Interactions

  • There are certain drugs that may cause clinically significant drug interactions with Tresiba®.
    • Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors
    • Drugs that may decrease the blood glucose lowering effect: atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones
    • Drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine
    • Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine

Please click here for Tresiba® Prescribing Information.

References:

  1. Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; November 2019.
  2. Levemir [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2019.

 

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