Insulin Degludec

What it is and how it works

Mechanism of Action The primary activity of insulin, including Insulin Degludec, is regulation of glucose metabolism. Insulin 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. Insulin Degludec forms multi-hexamers when injected into the subcutaneous tissue resulting in a subcutaneous insulin degludec depot.

Indications

Insulin Degludec is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use • Not recommended for the treatment of diabetic ketoacidosis. Insulin Degludec is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older 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 Insulin Degludec subcutaneously into the thigh, upper arm, or abdomen . • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis . • For pediatric patients requiring less than 5 units of Insulin Degludec each day, use an Insulin Degludec U-100 vial . • In adults, inject subcutaneously once daily at any time of day . • In pediatric patients inject subcutaneously once daily at the same time every day . • Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal .

Contraindications

Insulin Degludec is contraindicated: • During episodes of hypoglycemia . • In patients with hypersensitivity to insulin degludec or any of the excipients in Insulin Degludec . • During episodes of hypoglycemia . • Hypersensitivity to insulin degludec or any of the excipients in Insulin Degludec .

Warnings and precautions

• Never share an Insulin Degludec FlexTouch pen, 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 monitoring with changes to: insulin dosage, concomitant drugs, meal pattern, physical activity.

Pregnancy

Pregnancy Risk Summary Available data from one unpublished trial and the published literature with Insulin Degludec use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Storage and supply

Product: 50090-7175 NDC: 50090-7175-0 3 mL in a SYRINGE, PLASTIC / 3 in a CARTON

Source: Insulin Degludec (Insulin Degludec) — US FDA prescribing information, 2024-05-31, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.