Mitapivat is a pyruvate kinase activator indicated for the treatment of anemia in adults with alpha- or beta-thalassemia. It is available as tablets and kits for oral use. MedsAcross supplies Mitapivat 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.
AQVESME is indicated for the treatment of anemia in adults with alpha- or beta-thalassemia. AQVESME is a pyruvate kinase activator indicated for the treatment of anemia in adults with alpha- or beta-thalassemia.
Source: US FDA prescribing information
Mitapivat is a pyruvate kinase activator that acts by allosterically binding to the pyruvate kinase tetramer and increasing pyruvate kinase (PK) activity. Imbalances in globin chain production during erythropoiesis result in increased oxidative stress, which leads to ineffective erythropoiesis and hemolysis. In nonclinical models of beta-thalassemia, mitapivat improved energy homeostasis, RBC longevity, ineffective erythropoiesis, and hemolysis by increasing PK activity.
Source: US FDA prescribing information
The tablet should be swallowed whole. Do not split, crush, chew, or dissolve the tablets. Recommended dose is 100 mg orally twice daily with or without food.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (hepatocellular injury aqvesme): can cause serious hepatocellular injury. Measure liver laboratory tests (ALT, AST, alkaline phosphatase, and total bilirubin with fractionation) at baseline and every 4 weeks for 24 weeks and then as clinically indicated. Avoid use of AQVESME in patients with cirrhosis. Discontinue AQVESME if hepatic injury is suspected. Hepatocellular Injury AQVESME can cause hepatocellular injury. Avoid use of AQVESME in patients with cirrhosis. In patients with thalassemia treated with AQVESME, liver injury with and without jaundice has been observed within the first 6 months of exposure. Obtain liver tests (including ALT, AST, alkaline phosphatase, total bilirubin with fractionation) prior to the initiation of AQVESME, then every 4 weeks for the first 24 weeks, and as clinically indicated thereafter.
Source: US FDA prescribing information
The following clinically significant adverse reaction is described elsewhere in labeling: Hepatocellular Injury. The most common adverse reactions were headache and insomnia.
Source: US FDA prescribing information
Strong CYP3A Inhibitors and Inducers: Avoid concomitant use. Moderate CYP3A Inhibitors: Avoid concomitant use. Moderate CYP3A Inducers: Consider alternatives that are not moderate inducers. If there are no alternatives, see Full Prescribing Information for recommended dosage for drug interactions with moderate CYP3A inducers. Sensitive CYP3A substrates including hormonal contraceptives: Avoid concomitant use with substrates that have narrow therapeutic index. CYP2B6, CYP2C and UGT1A1 Substrates: Monitor patients for efficacy of the substrates with narrow therapeutic index. P-gp Substrates: Monitor patients for adverse reactions of the substrates with narrow therapeutic index.
Source: US FDA prescribing information
Storage Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15ºC and 30ºC (59ºF and 86ºF). Store the blister wallets in the original carton until use.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
5 presentations of Mitapivat, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Pyrukynd kit | Agios Pharmaceuticals | US FDA | Available on request |
| Pyrukynd 5 mg tabletOral | Agios Pharmaceuticals | US FDA | Available on request |
| Aqvesme 100 mg tabletOral | Agios Pharmaceuticals | US FDA | Available on request |
| Pyrukynd 20 mg tabletOral | Agios Pharmaceuticals | US FDA | Available on request |
| Pyrukynd 50 mg tabletOral | Agios Pharmaceuticals | US FDA | Available on request |
2 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 5 presentations of Mitapivat and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Mitapivat, including Aqvesme, Pyrukynd.
Yes. The US FDA first approved Mitapivat on 17 February 2022, according to Drugs@FDA.
Yes. Mitapivat has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Mitapivat is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Mitapivat is classified under ATC code B06AX04 (Mitapivat).
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