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 60 mg/40 mg/80 mg granules in sachet.
Kaftrio 75 mg/50 mg/100 mg granules in sachet.
| Pharmaceutical Form |
|---|
|
Granules in sachet. White to off-white, sweetened, unflavoured granules approximately 2 mm in diameter. |
Each sachet contains 60 mg of ivacaftor, 40 mg of tezacaftor and 80 mg of elexacaftor.
Excipient with known effect: Each sachet contains 188.6 mg of lactose monohydrate.
Each sachet contains 75 mg of ivacaftor, 50 mg of tezacaftor and 100 mg of elexacaftor.
Excipient with known effect: Each sachet contains 235.7 mg of lactose monohydrate.
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 |
|---|
|
Silica, colloidal anhydrous (E551) |
Biaxially-oriented polyethylene terephthalate/polyethylene/foil/polyethylene (BOPET/PE/Foil/PE) printed foil laminate sachet.
Pack size of 28 sachets (4 weekly wallets, each with 7 sachets).
Vertex Pharmaceuticals (Ireland) Limited, Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland
EU/1/20/1468/003
EU/1/20/1468/004
Date of first authorisation: 21 August 2020
| Drug | Countries | |
|---|---|---|
| KAFTRIO | Austria, Estonia, Finland, Croatia, Ireland, Italy, 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.
