Kaftrio
ivacaftor / tezacaftor / elexacaftor
Table of contents
Overview
Kaftrio is a medicine used to treat patients aged 12 years and above who have cystic fibrosis, an inherited disease that has severe effects on the lungs, the digestive system and other organs.
Cystic fibrosis can be caused by various mutations (changes) in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator’ (CFTR). People have 2 copies of this gene, one inherited from each parent and the disease only occurs when there is a mutation in both copies.
Kaftrio is used in patients whose cystic fibrosis is due to the F508del mutation inherited from one or both parents. If they have inherited this mutation from only one parent, they should also have another mutation called a ‘minimal function mutation’ from the other parent.
Cystic fibrosis is rare, and Kaftrio was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 14 December 2018. Further information on the orphan designation is available.
Kaftrio contains the active substances ivacaftor, tezacaftor and elexacaftor.
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Kaftrio : EPAR - Medicine overview (PDF/97.03 KB)
First published: 21/08/2020
EMA/352917/2020 -
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Kaftrio : EPAR - Risk-management-plan summary (PDF/130.01 KB) (updated)
First published: 21/08/2020
Last updated: 17/03/2021
Authorisation details
Product details | |
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Name |
Kaftrio
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Agency product number |
EMEA/H/C/005269
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Cystic Fibrosis
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Anatomical therapeutic chemical (ATC) code |
R07AX
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Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Vertex Pharmaceuticals (Ireland) Limited
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Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
21/08/2020
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Contact address |
28-32 Pembroke Street Upper |
Product information
11/02/2021 Kaftrio - EMEA/H/C/005269 - II/0003
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Therapeutic indication
Kaftrio is indicated in a combination regimen with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or heterozygous for F508del in the CFTR gene with a minimal function (MF) mutation.