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Molecule

Insulin detemir

Insulin [Chemical/Ingredient]
Available on requestBiologicDiabetes
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Insulin detemir is an insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. It is available as injection for subcutaneous use. MedsAcross supplies Insulin detemir 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

Key facts

Pharmacological class
Insulin [Chemical/Ingredient], Insulin Analog
ATC classification
A10AE05 Insulin detemir · Lente insulin
US FDA first approval
19 October 2005
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII 4FT78T86XVRxCUI 139825CAS 169148-63-4DrugBank DB01307Q410965

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

LEVEMIR 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.

Source: US FDA prescribing information

How it works

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.

Source: US FDA prescribing information

Dosing overview

• 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.

Source: US FDA prescribing information

Contraindications

LEVEMIR is contraindicated: • During episodes of hypoglycemia • In patients with hypersensitivity to insulin detemir or any of the excipients in LEVEMIR. Reactions have included anaphylaxis. • During episodes of hypoglycemia. • Hypersensitivity to insulin detemir or any of the excipients in LEVEMIR

Source: US FDA prescribing information

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, 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

Side effects

The following adverse reactions are discussed elsewhere: • Hypoglycemia • Hypoglycemia Due to Medication errors • Hypersensitivity Reactions • Hypokalemia Adverse reactions associated with LEVEMIR include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash and pruritus.

Source: US FDA prescribing information

Interactions

Table 6 includes clinically significant drug interactions with LEVEMIR. Table 6: Clinically Significant Drug Interactions with LEVEMIR 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 LEVEMIR is co-administered with these drugs.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Insulin detemir, sorted by availability.

MedicineManufacturerRegisterAvailability
Levemir 100 IU/mL injectionSubcutaneousA-S Medication SolutionsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 19 October 2005Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Insulin detemir in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Insulin detemir available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Insulin detemir and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Insulin detemir have?

The catalogue lists 1 brand names for Insulin detemir, including Levemir.

Is Insulin detemir approved by the US FDA?

Yes. The US FDA first approved Insulin detemir on 19 October 2005, according to Drugs@FDA.

Is Insulin detemir authorised in the European Union?

Yes. Insulin detemir has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Insulin detemir need cold chain shipping?

No listed presentation of Insulin detemir is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Insulin detemir in?

Insulin detemir is classified under ATC code A10AE05 (Insulin detemir).

References

  1. Levemir prescribing information (A-S Medication Solutions). U.S. National Library of Medicine, DailyMed. Retrieved 9 October 2024
  2. Levemir: European public assessment report (EPAR). European Medicines Agency. Retrieved 13 July 2021

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