Insulin Detemir

What it is and how it works

Mechanism of Action The primary activity of insulin, including LEVEMIR, is regulation of glucose metabolism. Insulins and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis.

Indications

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 is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus . Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis.

Dosage and administration (summary)

• See Full Prescribing Information for important administration instructions . • Inject subcutaneously into the thigh, upper arm, or abdomen . • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis . • Individualize and titrate the dose of LEVEMIR based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal . • Administer subcutaneously once daily or in divided doses twice daily . • See Full Prescribing Information for recommended starting dose in insulin naïve patients and patients already on insulin therapy ( 2.3 , 2.4 ). Important Administration Instructions • Always check insulin labels before administration .

Contraindications

is contraindicated: • During episodes of hypoglycemia • In patients with hypersensitivity to insulin detemir or any of the excipients in LEVEMIR. Reactions have included anaphylaxis [ see Warnings and Precautions and Adverse Reactions ] . • During episodes of hypoglycemia • Hypersensitivity to insulin detemir or any of the excipients in LEVEMIR

Warnings and precautions

• Never Share a LEVEMIR FlexPen, insulin syringe, or needle between patients, even if the needle is changed . • Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring . • Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitant drugs, meal pattern, physical activity.

Pregnancy

Pregnancy Risk Summary 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.

Storage and supply

Product: 50090-1276 NDC: 50090-1276-0 10 mL in a VIAL, GLASS / 1 in a CARTON Product: 50090-1475

Source: Insulin Detemir (Levemir) — US FDA prescribing information, 2024-10-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.