brigatinib
Alunbrig · ATC code L01XE43
- Key facts
- Active substance
- brigatinib
- Drug class
- ALK inhibitor
- ATC code
- L01XE43
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Alunbrig 30 mg film-coated tablets / Alunbrig 90 mg film-coated tablets / Alunbrig 180 mg film-coated tablets
- Marketing authorisation holder
- Takeda Pharma A/S
- Information as of
- 2026-10-29
Key facts
Brigatinib is a tyrosine kinase inhibitor targeting anaplastic lymphoma kinase (ALK). It is used as monotherapy for ALK-positive advanced non-small cell lung cancer (NSCLC).
What it is used for
- Adults with ALK-positive advanced NSCLC not previously treated with an ALK inhibitor.
- Adults with ALK-positive advanced NSCLC previously treated with crizotinib.
Dosing
- Alunbrig (film-coated tablets): starting dose 90 mg once daily for the first 7 days, then 180 mg once daily, as long as clinical benefit is observed.
- After an interruption of 14 days or longer (not for adverse reactions), resume at 90 mg once daily for 7 days before increasing to the previously tolerated dose.
- Dose reduction is stepwise (180 → 120 → 90 → 60 mg once daily); discontinue permanently if 60 mg is not tolerated. For adverse-reaction management see the full text.
- Avoid strong CYP3A inhibitors; if unavoidable, reduce the dose by approximately 50% (from 180 mg to 90 mg, or from 90 mg to 60 mg).
- Missed dose or vomiting: no additional dose, take the next dose at the scheduled time. For renal or hepatic impairment see the full text.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
Important warnings
- Severe, life-threatening and fatal pulmonary adverse reactions (ILD/pneumonitis), mostly within the first 7 days; monitor respiratory symptoms, particularly in the first week.
- Hypertension and bradycardia: monitor blood pressure and heart rate regularly.
- Visual disturbance: patients should report visual symptoms; consider ophthalmologic evaluation for severe symptoms.
- Elevations of CPK, amylase, lipase, liver enzymes and blood glucose: monitor regularly.
- Photosensitivity: avoid prolonged sun exposure during treatment and for at least 5 days after stopping.
Side effects
- Most common (≥ 25%): increased AST, CPK, ALT, lipase and amylase, hyperglycaemia, hyperinsulinaemia, diarrhoea, anaemia, nausea, fatigue, cough, rash, myalgia, headache, hypertension, dyspnoea, vomiting.
- Most common serious adverse reactions (≥ 2%): pneumonia, pneumonitis, dyspnoea and pyrexia.
Interactions
- Strong CYP3A inhibitors (e.g. ritonavir, clarithromycin, ketoconazole, voriconazole) increase brigatinib levels – avoid or reduce the dose.
- Avoid strong and moderate CYP3A inducers.
- Brigatinib reduces levels of CYP3A substrates; avoid narrow-therapeutic-index CYP3A substrates (e.g. fentanyl, ciclosporin, tacrolimus). Caution with other agents causing bradycardia.
Pregnancy and breastfeeding
- Women should use effective non-hormonal contraception during treatment and for at least 4 months after the final dose; men with female partners of reproductive potential for at least 3 months after the last dose.
Summary of the official product information, written with AI on 2026-10-29. 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
This product has no separate US patient information.
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)
- AlunbrigTakeda Pharma A/S · EMEA/H/C/004248
Source: European Medicines Agency (EMA), product information
Turkey
- AlunbrigTAKEDA İLAÇ SAĞLIK SAN. TİC. LTD. ŞTİ. · 9 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Alunbrig
- Liechtenstein
- Alunbrig
- Norway
- Alunbrig
EMA – Article 57 product data (EU/EEA), 2026-10-29
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
- European Medicines Agency. Alunbrig – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/alunbrig-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L01XE.
Editorial: Medelix editorial team · last updated 2026-10-29 · 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.