MedeliX
Start asking

Elexacaftor / Ivacaftor / Tezacaftor

Kaftrio · ATC code R07AX32

Key facts
Active substance
Elexacaftor / Ivacaftor / Tezacaftor
ATC code
R07AX32
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets / Kaftrio 75 mg/50 mg/100 mg film-coated tablets · Kaftrio 60 mg/40 mg/80 mg granules in sachet / Kaftrio 75 mg/50 mg/100 mg granules in sachet
Marketing authorisation holder
Vertex Pharmaceuticals (Ireland) Limited
Information as of
2026-10-27

Key facts

Elexacaftor/tezacaftor/ivacaftor (Kaftrio) is a combination of CFTR modulators. It is used with ivacaftor to treat cystic fibrosis in patients with at least one non-Class I mutation in the CFTR gene.

What it is used for

  • Tablets: cystic fibrosis from 6 years with at least one non-Class I CFTR mutation, in combination with ivacaftor
  • Granules: cystic fibrosis in children aged 2 to less than 6 years with the same requirement
  • Not expected to work in patients with two Class I (null) mutations

Dosing

  • 12 years and older: two ivacaftor 75 mg/tezacaftor 50 mg/elexacaftor 100 mg tablets in the morning, one ivacaftor 150 mg tablet in the evening
  • 6 to <12 years: dose by body weight (cut-off 30 kg) per the table in the full text
  • 2 to less than 6 years (granules): one sachet in the morning and one ivacaftor sachet in the evening, strength by body weight (cut-off 14 kg)
  • Morning and evening doses approximately 12 hours apart, with fat-containing food
  • Reduce dose with moderate or strong CYP3A inhibitors as per the full text
  • Check transaminases and bilirubin before starting, every 3 months in the first year, then annually

Contraindications

  • Hypersensitivity to the active substances or any of the excipients

Important warnings

  • Liver failure leading to transplantation reported within the first 6 months; transaminase elevations are common
  • Interrupt if ALT or AST >5 × ULN, or >3 × ULN with total bilirubin >2 × ULN
  • Serious rash may occur
  • Depression and behavioural changes have been reported

Side effects

  • Most common from 12 years: headache (17.3%), diarrhoea (12.9%), upper respiratory tract infection (11.9%), aminotransferase increased (10.9%)
  • Serious rash in 1.5% of patients
  • Common: rhinitis, influenza, hypoglycaemia; very common: dizziness

Interactions

  • Strong CYP3A inducers (e.g. rifampicin, carbamazepine, phenytoin, St. John's wort) not recommended due to loss of efficacy
  • CYP3A inhibitors (e.g. fluconazole, clarithromycin, itraconazole) require dose reduction

Pregnancy and breastfeeding

  • No malformative toxicity indicated; as a precaution, preferably avoid use during pregnancy

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.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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)

  • KaftrioVertex Pharmaceuticals (Ireland) Limited · EMEA/H/C/005269

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Kaftrio
Liechtenstein
Kaftrio
Norway
Kaftrio

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.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Kaftrio – 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/kaftrio-epar-product-information_en.pdf

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.