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cabozantinib

Cabometyx, Cometriq · ATC code L01EX07

Key facts
Active substance
cabozantinib
ATC code
L01EX07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
CABOMETYX 20 mg film-coated tablets / CABOMETYX 40 mg film-coated tablets / CABOMETYX 60 mg film-coated tablets · COMETRIQ 20 mg hard capsules / COMETRIQ 80 mg hard capsules
Marketing authorisation holder
Ipsen Pharma
Information as of
2026-10-27

Key facts

Cabozantinib is a tyrosine kinase inhibitor. As tablets (Cabometyx) it is used in renal cell, hepatocellular and thyroid carcinoma and neuroendocrine tumours; as capsules (Cometriq) in medullary thyroid carcinoma.

What it is used for

  • Cabometyx: advanced renal cell carcinoma (first-line in intermediate/poor risk, after VEGF-targeted therapy, or first-line with nivolumab)
  • Cabometyx: hepatocellular carcinoma after prior sorafenib
  • Cabometyx: differentiated thyroid carcinoma refractory to or not eligible for radioactive iodine, after prior systemic therapy
  • Cabometyx: unresectable or metastatic well-differentiated neuroendocrine tumours after prior systemic therapy
  • Cometriq: progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma in adults

Dosing

  • Cabometyx tablets and Cometriq capsules are not bioequivalent and must not be interchanged
  • Cabometyx monotherapy: 60 mg once daily; if needed reduce to 40 mg, then 20 mg daily
  • Cabometyx with nivolumab: 40 mg once daily; reduce to 20 mg daily, then 20 mg every other day
  • Cometriq: 140 mg once daily; reduce to 100 mg, then 60 mg daily
  • Do not take a missed dose if the next dose is due in less than 12 hours
  • Use strong CYP3A4 inhibitors with caution and avoid chronic strong inducers; caution in mild or moderate renal impairment

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Close evaluation during the first eight weeks; dose reductions and interruptions are frequent
  • Hepatotoxicity: test ALT, AST and bilirubin before starting and monitor closely
  • Perforations, fistulas and intra-abdominal abscesses
  • Early-onset reactions: hypocalcaemia, hypokalaemia, thrombocytopenia, hypertension, palmar-plantar erythrodysaesthesia, proteinuria

Side effects

  • Most frequent: diarrhoea, fatigue, nausea, decreased appetite, palmar-plantar erythrodysaesthesia, hypertension
  • Serious, including: pneumonia, pulmonary embolism, deep vein thrombosis, dehydration, hepatic encephalopathy (HCC), osteonecrosis of the jaw
  • Laboratory: increased AST/ALT, lymphopenia, hypocalcaemia, neutropenia, thrombocytopenia

Interactions

  • Strong CYP3A4 inhibitors (e.g. ritonavir, itraconazole, clarithromycin, grapefruit juice) increase exposure – use with caution
  • Strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, St John's wort) reduce exposure – avoid chronic use
  • Oral contraceptives may not be effective; use with a barrier method

Pregnancy and breastfeeding

  • No studies in pregnant women; embryo-foetal and teratogenic effects in animals
  • Effective contraception for male and female patients and partners during therapy and for at least 4 months after

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)

Source: European Medicines Agency (EMA), product information

Turkey

  • CabometyxGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 10 more European countries
Croatia
Kabozantinib Teva
Czechia
Cabozantinib Teva
Denmark
Cabozantinib Teva, Hasgobusno
Finland
Cabozantinib Ratiopharm
Iceland
Cabometyx, Cometriq
Italy
Cabozantinib Teva
Liechtenstein
Cabometyx, Cometriq
Norway
Cabometyx, Cometriq
Romania
Cabozantinib Terapia
Spain
Cabozantinib Sun

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

  1. European Medicines Agency. Cabometyx – 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/cabometyx-epar-product-information_en.pdf
  2. European Medicines Agency. Cometriq – 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/cometriq-epar-product-information_en.pdf
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

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.