Levemir Flexpen

The primary activity of insulin detemir is the regulation of glucose metabolism. Insulins, including insulin detemir, exert their specific action through binding to insulin receptors. Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.

Pregnancy Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.Nursing Mothers: It is unknown whether Insulin detemir is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, use caution when administering Insulin detemir to a nursing woman. Women with diabetes who are lactating may require adjustments of their insulin doses.

Pediatric Use: The pharmacokinetics, safety and effectiveness of subcutaneous injections of Insulin Detemir have been established in pediatric patients (age 6 to 17 years) with type 1 diabetes. Insulin Detemir has not been studied in pediatric patients younger than 6 years of age with type 1 diabetes. Insulin Detemir has not been studied in pediatric patients with type 2 diabetes. The dose recommendation when converting to Insulin Detemir is the same as that described for adults. As in adults, the dosage of Insulin Detemir must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose.

Geriatric Use: In controlled clinical trials comparing Insulin Detemir to NPH insulin or insulin glargine, 64 of 1624 patients (3.9%) in the type 1 diabetes trials and 309 of 1082 patients (28.6%) in the type 2 diabetes trials were≥65 years of age. A total of 52 (7 type 1 and 45 type 2) patients (1.9%) were ≥75 years of age. Nooverall differences in safety or effectiveness were observed between these patients and younger patients, but small sample sizes, particularly for patients ≥65 years of age in the type 1 diabetes trials and for patients ≥75 years of age in all trials limits conclusions. Greater sensitivity of some older individuals cannot be ruled out. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia. Hypoglycemia may be difficult to recognize in the elderly.

An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia

Unused (unopened) Levemir Flexpen should be stored in the refrigerator between 2° and 8°C. Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. Do not use Levemir Flexpen if it has been frozen. Unused (unopened) Levemir Flexpen can be kept until the expiration date printed on the label if it is stored in a refrigerator. Keep unused Levemir Flexpen in the carton so that it stays clean and protected from light.If refrigeration is not possible, unused (unopened) Levemir Flexpen can be kept unrefrigerated at room temperature, below 30°C as long as it is kept as cool as possible and away from direct heat and light. Unrefrigerated Levemir Flexpen should be discarded 42 days after it is first kept out of the refrigerator, even if the FlexPen or vial still contains insulin.