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Molecule

Insulin glulisine

Insulin [Chemical/Ingredient]
Available on requestBiologicCold chainDiabetes
Presentations
2
Brands
2
Manufacturers
1
Available from stock
0

Insulin glulisine is an insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. It is available as injection for subcutaneous and intravenous use. MedsAcross supplies Insulin glulisine 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
A10AB06 Insulin glulisine · Insulin analog, subgroup A10AB
US FDA first approval
Not recorded
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous, Intravenous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII 7XIY785AZDRxCUI 400008CAS 207748-29-6DrugBank DB01309Q6042242

Clinical information

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

Uses

APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. APIDRA is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

Source: US FDA prescribing information

How it works

Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin glulisine. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis and enhance protein synthesis.

Source: US FDA prescribing information

Dosing overview

See Full Prescribing Information for important administration instructions. Individualize and adjust the dosage of APIDRA based on route of administration, individual's metabolic needs, blood glucose monitoring results, and glycemic control goal. Dosage adjustments may be needed when switching from another insulin, with changes in physical activity, changes in concomitant medications, changes in meal patterns, changes in renal or hepatic function or during acute illness. Subcutaneous Injection: Inject within 15 minutes before a meal or within 20 minutes after starting a meal into the abdomen, thigh, or upper arm. Rotate injection sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Should generally be used in regimens with an intermediate or long-acting insulin.

Source: US FDA prescribing information

Contraindications

APIDRA is contraindicated: during episodes of hypoglycemia in patients with known hypersensitivity to insulin glulisine or to any of the excipients in APIDRA, systemic allergic reactions have occurred with APIDRA. Do not use during episodes of hypoglycemia. Do not use in patients with hypersensitivity to insulin glulisine or any excipients in APIDRA

Source: US FDA prescribing information

Warnings and precautions

Never share an APIDRA SoloStar pen 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, coadministered glucose lowering medications, 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. Hypokalemia: May be life-threatening.

Source: US FDA prescribing information

Side effects

The following adverse reactions are discussed elsewhere: Hypoglycemia Hypoglycemia Due to Medication Errors Hypokalemia Hypersensitivity Reactions Adverse reactions commonly associated with APIDRA include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, and weight gain.

Source: US FDA prescribing information

Interactions

Table 6: Clinically Significant Drug Interactions with APIDRA 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 analog (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when APIDRA is coadministered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of APIDRA Drugs: Atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, phenothiazine derivatives, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.

Source: US FDA prescribing information

Storage

Storage conditions are summarized in the following table: Not in-use (unopened) Refrigerated (36°F-46°F [2°C-8°C]). Protect from light Not in-use (unopened) Room Temperature (up to 77°F [25°C]) In-use (opened) 10 mL multiple-dose vial Until expiration date 28 days 28 days The in-use time for multiple-dose vial is either 28 days at room temperature up to 77°F (25°C) or 48 hours in insulin pump up to 98.6°F (37°C)., Refrigerated or room temperature 3 mL single-patient-use APIDRA SoloStar prefilled pen Until expiration date 28 days 28 days, Room temperature (Do not refrigerate) Use in an External Insulin Pump Change the APIDRA in the pump reservoir at least every 48 hours, or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 98.6°F (37°C).

Source: US FDA prescribing information

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

All presentations

2 presentations of Insulin glulisine, sorted by availability.

MedicineManufacturerRegisterAvailability
Apidra 100 IU/mL injectionIntravenous, subcutaneous Cold chainSanofi-AventisUS FDAAvailable on request
Apidra SoloStar 100 IU/mL injectionSubcutaneous Cold chainSanofi-AventisUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

Manufacturers

Regulatory status

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

RegisterStatusSource
US FDANot recorded—
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 glulisine in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Insulin glulisine available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Insulin glulisine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Insulin glulisine have?

The catalogue lists 2 brand names for Insulin glulisine, including Apidra, Apidra SoloStar.

Is Insulin glulisine authorised in the European Union?

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

Does Insulin glulisine need cold chain shipping?

At least one listed presentation of Insulin glulisine must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Insulin glulisine in?

Insulin glulisine is classified under ATC code A10AB06 (Insulin glulisine).

References

  1. Apidra prescribing information (sanofi-aventis). U.S. National Library of Medicine, DailyMed. Retrieved 25 November 2025
  2. Apidra: European public assessment report (EPAR). European Medicines Agency. Retrieved 5 March 2026

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