Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Agios Netherlands B.V., Zuidplein 36, Regus Amsterdam WTC, 1077XV Amsterdam, The Netherlands
Pyrukynd 5 mg film-coated tablets.
Pyrukynd 20 mg film-coated tablets.
Pyrukynd 50 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Pyrukynd 5 mg film-coated tablets: Blue, round film-coated tablets of approximately 5 mm in diameter with “M5” printed in black ink on one side and plain on the reverse. Pyrukynd 20 mg film-coated tablets: Blue, round film-coated tablets of approximately 8 mm in diameter with “M20” printed in black ink on one side and plain on the reverse. Pyrukynd 50 mg film-coated tablets: Blue, oblong shaped film-coated tablets of approximately 16 mm x 6.8 mm size with “M50” printed in black ink on one side and plain on the reverse. |
Pyrukynd 5 mg film-coated tablets: Each film-coated tablet contains 5 mg of mitapivat (as sulfate).
Excipient with known effect: Each film-coated tablet contains 0.3 mg of lactose (as monohydrate).
Pyrukynd 20 mg film-coated tablets: Each film-coated tablet contains 20 mg of mitapivat (as sulfate).
Excipient with known effect: Each film-coated tablet contains 1.4 mg of lactose (as monohydrate).
Pyrukynd 50 mg film-coated tablets: Each film-coated tablet contains 50 mg of mitapivat (as sulfate).
Excipient with known effect: Each film-coated tablet contains 3.4 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mitapivat |
Mitapivat is a pyruvate kinase activator and acts by directly binding to the pyruvate kinase tetramer. The red blood cell (RBC) form of pyruvate kinase (PKR) is mutated in PK deficiency, which leads to reduced adenosine triphosphate (ATP) levels, shortened RBC lifespan and chronic haemolysis. Mitapivat improves RBC energy homeostasis by increasing PKR activity. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film-coating: Hypromellose (E464) Printing ink: Shellac (E904) |
Mitapivat tablets are supplied in PVC/PCTFE/Al blister wallets in cartons.
Pyrukynd 5 mg film-coated tablets:
Carton containing 56 film-coated tablets in 4 blister wallets, each containing 14 film-coated tablets.
Pyrukynd 20 mg film-coated tablets:
Carton containing 56 film-coated tablets in 4 blister wallets, each containing 14 film-coated tablets.
Pyrukynd 50 mg film-coated tablets:
Carton containing 56 film-coated tablets in 4 blister wallets, each containing 14 film-coated tablets.
Pyrukynd 5 mg film-coated tablets:
Carton containing 7 film-coated tablets in a blister wallet.
Pyrukynd 20 mg film-coated tablets + Pyrukynd 5 mg film-coated tablets:
Each carton of 14 film-coated tablets contains:
7 film-coated tablets of Pyrukynd 20 mg
7 film-coated tablets of Pyrukynd 5 mg
Pyrukynd 50 mg film-coated tablets + Pyrukynd 20 mg film-coated tablets:
Each carton of 14 film-coated tablets contains:
7 film-coated tablets of Pyrukynd 50 mg
7 film-coated tablets of Pyrukynd 20 mg
Not all pack sizes may be marketed.
Agios Netherlands B.V., Zuidplein 36, Regus Amsterdam WTC, 1077XV Amsterdam, The Netherlands
EU/1/22/1662/001
EU/1/22/1662/002
EU/1/22/1662/003
EU/1/22/1662/004
EU/1/22/1662/005
EU/1/22/1662/006
| Drug | Countries | |
|---|---|---|
| PYRUKYND | Austria, France, Croatia, Ireland, Italy, Lithuania, United States |
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