Insulin degludec is an insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. It is available as injection for subcutaneous use. MedsAcross supplies Insulin degludec for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
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. The protracted time action profile of Insulin Degludec is predominantly due to delayed absorption of insulin degludec from the subcutaneous tissue to the systemic circulation and to a lesser extent due to binding of insulin-degludec to circulating albumin.
Source: US FDA prescribing information
• 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. • The recommended days between dose increases are 3 to 4 days. • See Full Prescribing Information for recommended starting dose in insulin naïve patients and patients already on insulin therapy.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
• 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, and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness. • Hypoglycemia due to medication errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection.
Source: US FDA prescribing information
The following adverse reactions are also discussed elsewhere: • Hypoglycemia • Hypoglycemia due to Medication errors • Hypersensitivity reactions • Hypokalemia Adverse reactions commonly associated with Insulin Degludec are: • hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.
Source: US FDA prescribing information
Table 5 includes clinically significant drug interactions with Insulin Degludec. Table 5: Clinically Significant Drug Interactions with Insulin Degludec Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors. Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when Insulin Degludec is co-administered with these drugs.
Source: US FDA prescribing information
Store unused Insulin Degludec in a refrigerator (36ºF to 46ºF [2ºC to 8ºC]). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. The storage conditions are summarized in Table 18: Table 18: Storage Conditions for Insulin Degludec Not in-use (unopened) In-use (opened) Refrigerated (36°F to 46°F [2°C to 8°C]) Room Temperature (up to 86°F [30°C]) Room Temperature (up to 86°F [30°C]) Refrigerated (36°F to 46°F [2°C to 8°C]) 3 mL single-patient-use Insulin Degludec U-100 FlexTouch Until expiration date 56 days (8 weeks) 56 days (8 weeks) 56 days (8 weeks) 10 mL multiple-dose Insulin Degludec U-100 Vial Until expiration date 56 days (8 weeks) 56 days (8 weeks) 56 days (8 weeks) 3 mL single-patient-use Insulin Degludec U-200 FlexTouch Until expiration date 56 days (8 weeks) 56 days (8 weeks) 56 days (8 weeks) Storage Dispense in the original sealed carton with the enclosed Instructions for Use.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Insulin degludec, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tresiba 200 units/mL injectionSubcutaneous | Novo Nordisk | US FDA | Available on request |
| Insulin degludec 100 units/mL injectionSubcutaneous Cold chainGeneric name | — | US FDA | Available on request |
| Tresiba 100 units/mL injectionSubcutaneous Cold chain | Novo Nordisk | US FDA | Available on request |
| Insulin degludec 200 units/mL injectionSubcutaneous Cold chainGeneric name | — | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 4 presentations of Insulin degludec and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Insulin degludec, including Tresiba.
Yes. The US FDA first approved Insulin degludec on 25 September 2015, according to Drugs@FDA.
Yes. Insulin degludec has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Insulin degludec must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Insulin degludec is classified under ATC code A10AD06 (Insulin degludec).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.