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Molecule

Insulin aspart

Insulin Analog
Available on requestBiologicCold chainDiabetes
Presentations
10
Brands
8
Manufacturers
7
Available from stock
0

Insulin aspart is an insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. It is available as injection and injectable suspension for subcutaneous and intravenous use. MedsAcross supplies Insulin aspart 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 Analog
ATC classification
A10AB05 Insulin aspart · Insulin analog, subgroup A10ABA10AD05 Insulin aspart · Insulin analog, subgroup A10AD
US FDA first approval
29 September 2017
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, Injectable suspension
Biologic
Yes
Identifiers
UNII D933668QVXRxCUI 51428CAS 116094-23-6Q2754775

Clinical information

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

Uses

FIASP is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. • FIASP 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

The primary activity of FIASP is the regulation of glucose metabolism. Insulins, including insulin aspart, the active ingredient in FIASP, exert their specific action through binding to insulin receptors. Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.

Source: US FDA prescribing information

Dosing overview

• Individualize and adjust the dosage of FIASP 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: o Inject at the start of a meal or within 20 minutes after starting a meal into the abdomen, upper arm, or thigh. o Rotate injection sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. o Should generally be used in regimens with an intermediate- or long-acting insulin. • Continuous Subcutaneous Infusion (Insulin Pump): o Refer to the insulin infusion pump user manual to see if FIASP can be used.

Source: US FDA prescribing information

Contraindications

FIASP is contraindicated: • During episodes of hypoglycemia. • In patients with known hypersensitivity to insulin aspart or any of the excipients in FIASP. • During episodes of hypoglycemia. • Hypersensitivity to insulin aspart or any of the excipients in FIASP.

Source: US FDA prescribing information

Warnings and precautions

• Never share a FIASP FlexTouch pen, PenFill cartridge or PenFill cartridge device 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, co-administered 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 clinically significant adverse reactions are described elsewhere in labeling: • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen • Hypoglycemia • Hypokalemia • Hypersensitivity and allergic reactions Adverse reactions observed with FIASP include: hypoglycemia, allergic reactions, hypersensitivity, injection/infusion site reactions, lipodystrophy, and weight gain.

Source: US FDA prescribing information

Interactions

Table 5 includes clinically significant drug interactions with FIASP. Table 5. Clinically Significant Drug Interactions with FIASP 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. Intervention: Dose reductions and increased frequency of glucose monitoring may be required when FIASP is co-administered with these drugs.

Source: US FDA prescribing information

Storage

Unused FIASP vials should be stored between 2° to 8°C (36° to 46°F) in a refrigerator, but not in or near a freezing compartment. Storage Conditions for Vial, FIASP FlexTouch, PenFill Cartridges and PumpCart Cartridges FIASP presentation Not in-use (unopened) In-use (opened) Room Temperature (up to 30°C [86°F]) Refrigerated (2°C to 8°C [36°F to 46°F]) Room Temperature (up to 30°C [86°F]) Refrigerated (2°C to 8°C [36°F to 46°F]) 10 mL multiple-dose vial 28 days Until expiration date 28 days* (up to 30°C [86°F]) 28 days* 3 mL single-patient-use FIASP FlexTouch pen 28 days Until expiration date 28 days (up to 30°C [86°F]) 28 days 3 mL single-patient-use PenFill cartridges 28 days Until…

Source: US FDA prescribing information

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

All presentations

10 presentations of Insulin aspart, sorted by availability.

MedicineManufacturerRegisterAvailability
Novolog 100 IU/mL injectionIntravenous, subcutaneous Cold chainNovo NordiskUS FDAAvailable on request
Insulin aspart 100 IU/mL injectionIntravenous, subcutaneous Cold chainGeneric name—US FDAAvailable on request
NovoLog Mix 70/30 100 IU/mL injectable suspensionSubcutaneous Cold chainNovo Nordisk Pharmaceutical IndustriesUS FDAAvailable on request
Fiasp 100 IU/mL injectionSubcutaneous Cold chainNovo NordiskUS FDAAvailable on request
Insulin Aspart Protamine and Insulin Aspart Mix 70/30 100 IU/mL injectable suspensionSubcutaneous Cold chainNovo Nordisk PharmaUS FDAAvailable on request
Kirsty 100 IU/mL injectionIntravenous, subcutaneous Cold chainBiocon BiologicsIndiaUS FDAAvailable on request
Merilog 100 IU/mL injectionIntravenous, subcutaneous Cold chainSanofi-AventisUS FDAAvailable on request
.Insulin Aspart Protamine and Insulin Aspart 100 IU/mL injectable suspensionSubcutaneousA-S Medication SolutionsUS FDAAvailable on request
Garzulys 100 IU/mL injectionSubcutaneous Cold chainMeitheal PharmaceuticalsUS FDAAvailable on request
Garzulys 100 IU/mL injectionIntravenous, subcutaneous Cold chainMeitheal PharmaceuticalsUS FDAAvailable on request

Brands by market

8 brand names across 1 markets.

Brand names by country

Manufacturers

Indian manufacturers are highlighted.

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 29 September 2017Drugs@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 aspart in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Insulin aspart available for export from India?

Yes, on request. MedsAcross lists 10 presentations of Insulin aspart and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Biocon Biologics.

What brand names does Insulin aspart have?

The catalogue lists 8 brand names for Insulin aspart, including .Insulin Aspart Protamine and Insulin Aspart, Fiasp, Garzulys, Insulin Aspart Protamine and Insulin Aspart Mix 70/30, Kirsty, Merilog, Novolog, NovoLog Mix 70/30.

Is Insulin aspart approved by the US FDA?

Yes. The US FDA first approved Insulin aspart on 29 September 2017, according to Drugs@FDA.

Is Insulin aspart authorised in the European Union?

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

Does Insulin aspart need cold chain shipping?

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

Which ATC class is Insulin aspart in?

Insulin aspart is classified under ATC code A10AB05 (Insulin aspart).

References

  1. Fiasp prescribing information (Novo Nordisk). U.S. National Library of Medicine, DailyMed. Retrieved 21 June 2023
  2. Fiasp: European public assessment report (EPAR). European Medicines Agency. Retrieved 23 September 2021
  3. NovoMix: European public assessment report (EPAR). European Medicines Agency. Retrieved 29 August 2023

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