- Levemir® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Levemir® or any of its excipients. Reactions have included anaphylaxis.
Please read the Important Safety Information below
Levemir® Selected Important Safety Information
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.
Levemir® Important Safety Information
Warnings and Precautions (cont'd)
- 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 associated with Levemir® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash, pruritus.
- 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.
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