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Ivacaftor / Tezacaftor

Symkevi · ATC code R07AX31

Key facts
Active substance
Ivacaftor / Tezacaftor
ATC code
R07AX31
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Symkevi 50 mg/75 mg film-coated tablets / Symkevi 100 mg/150 mg film-coated tablets
Marketing authorisation holder
Vertex Pharmaceuticals (Ireland) Limited
Information as of
2026-10-27

Key facts

Ivacaftor/tezacaftor (Symkevi) is a combination of CFTR modulators. It is used with ivacaftor tablets to treat cystic fibrosis in patients aged 6 years and older with specific CFTR mutations.

What it is used for

  • Cystic fibrosis in patients aged 6 years and older who are homozygous for F508del
  • Or heterozygous for F508del with one of the listed second mutations (e.g. P67L, R117C, A455E, 3849+10kbC→T)
  • Always in combination with ivacaftor tablets

Dosing

  • 12 years and older, and 6 to < 12 years weighing ≥ 30 kg: morning tezacaftor 100 mg/ivacaftor 150 mg, evening ivacaftor 150 mg
  • 6 to < 12 years weighing < 30 kg: morning tezacaftor 50 mg/ivacaftor 75 mg, evening ivacaftor 75 mg
  • Doses approximately 12 hours apart with fat-containing food
  • With moderate or strong CYP3A inhibitors a reduced schedule applies (e.g. strong inhibitors: one morning tablet twice a week, no evening dose)
  • Reduced dose in moderate hepatic impairment; not recommended in severe hepatic impairment; details in the full text

Contraindications

  • Hypersensitivity to the active substances or any excipient

Important warnings

  • Not to be prescribed for F508del heterozygotes with a second mutation not listed
  • Elevated transaminases; liver failure leading to transplantation reported with other CFTR modulator regimens; LFTs before starting, every three months in the first year, then annually
  • Non-congenital lens opacities reported in children; eye examinations recommended
  • Avoid grapefruit

Side effects

  • Most common (12 years and older): headache (14%) and nasopharyngitis (12%)
  • Also very common: upper respiratory tract infection, dizziness, oropharyngeal pain, abdominal pain, diarrhoea, transaminase elevations
  • Common: nausea, ear discomfort, tinnitus

Interactions

  • Strong CYP3A inducers (e.g. rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin, St John's wort): not recommended; rifampicin decreased ivacaftor exposure by 89%
  • Moderate and strong CYP3A inhibitors (e.g. fluconazole, erythromycin, ketoconazole, clarithromycin): dose reduction required

Pregnancy and breastfeeding

  • Pregnancy: limited data; as a precaution, use should preferably be avoided
  • Breast-feeding: excreted into human milk; decide whether to stop breast-feeding or therapy

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)

  • SymkeviVertex Pharmaceuticals (Ireland) Limited · EMEA/H/C/004682

Source: European Medicines Agency (EMA), product information

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

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

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Sources

  1. European Medicines Agency. Symkevi – 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/symkevi-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.