ivacaftor
Kalydeco · ATC code R07AX02
Brand names: Kalydeco, Ivacaftor Accord, Ivacaftor Stada, Ivacaftor Al, Ivacaftor Basics, Ivacaftor Elpen
- Key facts
- Active substance
- ivacaftor
- ATC code
- R07AX02
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Kalydeco 75 mg film-coated tablets / Kalydeco 150 mg film-coated tablets · Kalydeco 13.4 mg granules in sachet / Kalydeco 25 mg granules in sachet / Kalydeco 50 mg granules in sachet
- Marketing authorisation holder
- Vertex Pharmaceuticals (Ireland) Limited
- Information as of
- 2026-10-27
Key facts
Ivacaftor is a CFTR potentiator (Kalydeco). It is used in cystic fibrosis with specific CFTR mutations, alone or in combination with tezacaftor/ivacaftor or ivacaftor/tezacaftor/elexacaftor.
What it is used for
- Tablets, monotherapy: CF aged 6 years and older and 25 kg or more with an R117H or specified gating mutation (e.g., G551D)
- Tablets, with tezacaftor/ivacaftor: CF aged 6 years and older, homozygous for F508del or heterozygous with specified second mutations
- Tablets, with ivacaftor/tezacaftor/elexacaftor: CF aged 6 years and older with at least one non-Class I mutation
- Granules, monotherapy: infants from 1 month and children 3 kg to less than 25 kg with an R117H or gating mutation
- Granules, with ivacaftor/tezacaftor/elexacaftor: children 2 to less than 6 years with at least one non-Class I mutation
Dosing
- Prescribed only by physicians experienced in CF; genotype confirmed before starting
- Monotherapy, 6 years and older and ≥ 25 kg: one 150 mg tablet morning and evening
- In combination: combination tablet(s) in the morning, one ivacaftor tablet in the evening (75 mg or 150 mg by age and weight)
- Morning and evening doses about 12 hours apart with fat-containing food
- Missed dose: take only if 6 hours or less have passed
- Weight-based granule dosing and adjustments for CYP3A inhibitors and hepatic impairment are in the full text
Contraindications
- Hypersensitivity to the active substance or any of the excipients
Important warnings
- Elevated transaminases and hepatic injury; monitor liver tests
- Monotherapy not recommended in patients homozygous for F508del
- Efficacy with the G970R mutation not established; less benefit with R117H-7T
- Avoid strong CYP3A inducers
Side effects
- 6 years and older: headache (23.9%), oropharyngeal pain (22.0%), upper respiratory tract infection (22.0%), nasal congestion (20.2%)
- Abdominal pain (15.6%), diarrhoea (12.8%), rash (12.8%), dizziness (9.2%)
- Transaminase elevations (12.8% vs. 11.5% on placebo)
- Serious: abdominal pain (0.9%), transaminase elevations (1.8%)
Interactions
- Strong CYP3A inducers (rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John's wort) not recommended; rifampicin decreased exposure by 89%
- CYP3A inhibitors increase exposure; dose reductions are in the full text
- Ivacaftor is a weak inhibitor of CYP3A and P-gp and a potential CYP2C9 inhibitor
Pregnancy and breastfeeding
- As a precaution, use during pregnancy is preferably avoided
- Ivacaftor is excreted into human milk; breast-feeding and therapy are weighed
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- KalydecoVertex Pharmaceuticals (Ireland) Limited · EMEA/H/C/002494
Source: European Medicines Agency (EMA), product information
Austria
- Ivacaftor AccordAccord Healthcare B.V. · 1 register entry
- Ivacaftor StadaStada Arzneimittel Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Ivacaftor AlAliud Pharma Gmbh · 1 register entry
- Ivacaftor BasicsBasics Gmbh · 1 register entry
- Ivacaftor ElpenElpen Pharmaceutical Co. Inc. · 1 register entry
- Ivacaftor StadaStadapharm Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Brand names in 26 more European countries
- Belgium
- Ivacaftor Ab, Ivacaftor Accord, Ivacaftor Eg
- Croatia
- Ivacaftor Accord, Ivakaftor Galenika, Ivakaftor Pliva, Ivakaftor Teva
- Cyprus
- Vaftor
- Czechia
- Ivacaftor Accord
- Denmark
- Ivacaftor "stada", Ivacaftor Accord, Ivacaftor Lupin Europe Gmbh, Ivacaftor Zentiva
- Estonia
- Ivacaftor Stada, Ivacaftor Teva
- Finland
- Ivacaftor Accord, Ivacaftor Stada Stada
- France
- Ivacaftor Accord, Ivacaftor Arrow, Ivacaftor Eg, Ivacaftor Intas, Ivacaftor Sun, Ivacaftor Zentiva, Liqratur
- Greece
- Ivacaftor Win Medica, Qulventra, Tinvek, Vaftor
- Hungary
- Ivacaftor Galenika, Ivacaftor Stada
- Iceland
- Kalydeco
- Italy
- Ivacaftor Accord, Ivacaftor Aurobindo, Ivacaftor Intas, Ivacaftor Sun
- Latvia
- Ivacaftor Stada, Ivacaftor Teva
- Liechtenstein
- Kalydeco
- Lithuania
- Ivacaftor Stada
- Luxembourg
- Ivacaftor Ab, Ivacaftor Eg, Ivacaftor Teva, Ivacaftors Ab
- Malta
- Fidasercot, Flidepartoc, Qitraria
- Netherlands
- Ivacaftor Aurobindo, Ivacaftor Intas, Ivacaftor Lupin, Ivacaftor Stada, Ivacaftor Sun, Ivafib
- Norway
- Ivacaftor Accord, Ivacaftor Lupin Europe Gmbh, Ivacaftor Stada, Ivacaftor Zentiva, Kalydeco
- Poland
- Ivacaftor Accord, Ivacaftor Ranbaxy, Ivacaftor Stada
- Portugal
- Ivacaftor Accord, Ivacaftor Generis, Ivacaftor Stada
- Romania
- Ivacaftor Bioeel, Ivacaftor Stada, Ivacaftor Sun
- Slovakia
- Ivacaftor Stada
- Slovenia
- Ivakaftor Accord, Ivakaftor Galenika
- Spain
- Ivacaftor Accord, Ivacaftor Aurovitas, Ivacaftor Intas, Ivacaftor Stada, Ivacaftor Sun, Pefalpov
- Sweden
- Fidasercot, Flidepartoc, Ivacaftor Accord, Ivacaftor Aliud, Ivacaftor Elpen, Ivacaftor Lupin, Ivacaftor Stada Nordic, Ivacaftor Stada Stada, Ivacaftor Teva, Ivacaftor Win Medica, Ivacaftor Zentiva, Liqratur, Pefalpov, Qitraria, Qulventra, Vaftor, Yisctua
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- European Medicines Agency. Kalydeco – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/kalydeco-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.