As with all insulins, the glucose lowering effect time course of Levemir ® may vary among different patients or at different times in the same patient and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature. The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. Risk Factors for Hypoglycemia: The risk of hypoglycemia generally increases with intensity of glycemic control.
Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy, using drugs that block the sympathetic nervous system (e.g., beta-blockers), or who experience recurrent hypoglycemia. Hypoglycemia can happen suddenly and symptoms may differ in each patient and change over time in the same patient.
Hypoglycemia can impair concentration ability and reaction time this may place the patient and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin, including Levemir ®.Adjustments in concomitant anti-diabetic treatment may be needed. 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. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. 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. 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.Sharing poses a risk for transmission of blood-borne pathogens. Patients using Levemir ® vials should never share needles or syringes with another person. Never Share a Levemir ® FlexPen ® prefilled pen, Needle, or Syringe Between Patients: Levemir ® FlexPen ® prefilled pens must never be shared between patients, even if the needle is changed.Levemir ® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin detemir or any of the excipients in Levemir ®.Important Safety Information Contraindications Levemir ® is not recommended for the treatment of diabetic ketoacidosis. Levemir ® (insulin detemir) injection 100 U/mL is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.Indications and Usage for Levemir ® (insulin detemir) injection 100 U/mL
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