Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Blueprint Medicines (Netherlands) B.V., Gustav Mahlerplein 2, 1082 MA Amsterdam, Netherlands
AYVAKYT 25 mg film-coated tablets.
AYVAKYT 50 mg film-coated tablets.
AYVAKYT 100 mg film-coated tablets.
AYVAKYT 200 mg film-coated tablets.
AYVAKYT 300 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. AYVAKYT 25 mg film-coated tablets: Round, white film-coated tablet of 5 mm diameter with debossed text. One side reads "BLU" and the other side reads "25". AYVAKYT 50 mg film-coated tablets: Round, white film-coated tablet of 6 mm diameter with debossed text. One side reads "BLU" and the other side reads "50". AYVAKYT 100 mg film-coated tablets: Round, white film-coated tablet of 9 mm diameter, printed with blue ink "BLU" on one side and "100" on the other. AYVAKYT 200 mg film-coated tablets: Oval, white film-coated tablet of 16 mm in length and 8 mm in width, printed with blue ink "BLU" on one side and "200" on the other. AYVAKYT 300 mg film-coated tablets: Oval, white film-coated tablet of 18 mm in length and 9 mm in width, printed with blue ink "BLU" on one side and "300" on the other. |
AYVAKYT 25 mg film-coated tablets: Each film-coated tablet contains 25 mg of avapritinib.
AYVAKYT 50 mg film-coated tablets: Each film-coated tablet contains 50 mg of avapritinib.
AYVAKYT 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of avapritinib.
AYVAKYT 200 mg film-coated tablets: Each film-coated tablet contains 200 mg of avapritinib.
AYVAKYT 300 mg film-coated tablets: Each film-coated tablet contains 300 mg of avapritinib.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Avapritinib is a Type 1 kinase inhibitor that has demonstrated biochemical in vitro activity on the PDGFRA D842V and KIT D816V mutants associated with resistance to imatinib, sunitinib and regorafenib with half maximal inhibitory concentrations (IC50) of 0.24 nM and 0.27 nM, respectively, and greater potency against clinically relevant KIT exon 11, KIT exon 11/17 and KIT exon 17 mutants than against the KIT wild-type enzyme. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Tablet coat: Talc Printing ink (for 100 mg, 200 mg and 300 mg film-coated tablets only): Shellac glaze 45% (20% esterified) in ethanol |
High-density polyethylene (HDPE) bottle with child-resistant cap (polypropylene) with foiled induction seal liner (pulp backed heat induction foil) and a desiccant in canister.
Each carton contains one bottle with 30 film-coated tablets.
Blueprint Medicines (Netherlands) B.V., Gustav Mahlerplein 2, 1082 MA Amsterdam, Netherlands
AYVAKYT 25 mg film-coated tablets:
EU/1/20/1473/004
AYVAKYT 50 mg film-coated tablets:
EU/1/20/1473/005
AYVAKYT 100 mg film-coated tablets:
EU/1/20/1473/001
AYVAKYT 200 mg film-coated tablets:
EU/1/20/1473/002
AYVAKYT 300 mg film-coated tablets:
EU/1/20/1473/003
Date of first authorisation: 24 September 2020
Date of latest renewal: 24 July 2023
| Drug | Countries | |
|---|---|---|
| AYVAKYT | Austria, Estonia, France, Croatia, Ireland, Lithuania, Poland, Romania, United Kingdom |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.