Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Vertex Pharmaceuticals (Ireland) Limited, Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland
Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets.
Kaftrio 75 mg/50 mg/100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets: Light orange, capsule-shaped tablet debossed with “T50” on one side and plain on the other (dimensions 6.4 mm x 12.2 mm). Kaftrio 75 mg/50 mg/100 mg film-coated tablets: Orange, capsule-shaped tablet debossed with “T100” on one side and plain on the other (dimensions 7.9 mm x 15.5 mm). |
Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets: Each film-coated tablet contains 37.5 mg of ivacaftor, 25 mg of tezacaftor and 50 mg of elexacaftor.
Kaftrio 75 mg/50 mg/100 mg film-coated tablets: Each film-coated tablet contains 75 mg of ivacaftor, 50 mg of tezacaftor and 100 mg of elexacaftor.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ivacaftor |
Ivacaftor is a potentiator of the CFTR protein, i.e., in vitro ivacaftor increases CFTR channel gating to enhance chloride transport in specified gating mutations with reduced channel-open probability compared to normal CFTR. Ivacaftor also potentiated the channel-open probability of R117H-CFTR, which has both low channel-open probability (gating) and reduced channel current amplitude (conductance). |
|
| Ivacaftor, Tezacaftor and Elexacaftor |
Elexacaftor and tezacaftor are CFTR correctors that bind to different sites on the CFTR protein and have an additive effect in facilitating the cellular processing and trafficking of F508del-CFTR to increase the amount of CFTR protein delivered to the cell surface compared to either molecule alone. Ivacaftor potentiates the channel open probability (or gating) of the CFTR protein at the cell surface. The combined effect of elexacaftor, tezacaftor and ivacaftor is increased quantity and function of F508del-CFTR at the cell surface, resulting in increased CFTR activity as measured by CFTR mediated chloride transport. |
| List of Excipients |
|---|
|
Tablet core: Hypromellose (E464) Tablet film coat: Hypromellose (E464) |
Blister consisting of PCTFE (polychlorotrifluoroethylene) film laminated to PVC (polyvinyl chloride) film and sealed with blister foil lidding.
Pack size of 56 tablets (4 blister cards, each with 14 tablets).
Vertex Pharmaceuticals (Ireland) Limited, Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland
EU/1/20/1468/001
EU/1/20/1468/002
Date of first authorisation: 21 August 2020
| Drug | Countries | |
|---|---|---|
| KAFTRIO | Austria, Estonia, Finland, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom |
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