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zanubrutinib

Brukinsa · ATC code L01EL03

Key facts
Active substance
zanubrutinib
ATC code
L01EL03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
BRUKINSA 80 mg hard capsules · BRUKINSA 160 mg film-coated tablets
Marketing authorisation holder
BeOne Medicines Ireland Limited
Information as of
2026-10-27

Key facts

Zanubrutinib (BRUKINSA) is an oral Bruton's tyrosine kinase inhibitor. It is used in adults with Waldenström's macroglobulinaemia, marginal zone lymphoma, CLL and follicular lymphoma.

What it is used for

  • Waldenström's macroglobulinaemia after at least one prior therapy, or first line when unsuitable for chemo-immunotherapy
  • Marginal zone lymphoma after at least one prior anti-CD20-based therapy
  • Chronic lymphocytic leukaemia (monotherapy)
  • Relapsed or refractory follicular lymphoma after at least two prior systemic therapies, with obinutuzumab

Dosing

  • Total daily dose 320 mg: once daily (four 80 mg capsules or two 160 mg tablets) or 160 mg twice daily
  • Continue until disease progression or unacceptable toxicity
  • With obinutuzumab: take zanubrutinib before the infusion
  • Strong CYP3A inhibitors: 80 mg once daily; further adjustments for moderate inhibitors and inducers in the full text
  • Severe hepatic impairment (Child-Pugh C): 80 mg twice daily
  • Grade 3 or greater toxicity: interrupt, then resume at stepwise reduced doses

Contraindications

  • Hypersensitivity to the active substance or any of the excipients

Important warnings

  • Serious and fatal haemorrhage; no vitamin K antagonists, caution with anticoagulants and antiplatelets; consider withholding 3 to 7 days around surgery
  • Infections and cytopenias; monitor complete blood counts monthly
  • Second primary malignancies, mainly skin cancer; sun protection advised
  • Atrial fibrillation and flutter; tumour lysis syndrome

Side effects

  • Monotherapy, most common: upper respiratory tract infection (36%), bruising (32%), haemorrhage/haematoma (30%), neutropenia (30%), musculoskeletal pain (27%), rash (25%), pneumonia (24%)
  • Grade 3 or higher: neutropenia (21%), pneumonia (14%), hypertension (8%)
  • With obinutuzumab: thrombocytopenia (37%), neutropenia (31%), fatigue (27%)

Interactions

  • Strong and moderate CYP3A inhibitors (e.g. itraconazole, voriconazole, clarithromycin) increase exposure
  • Effect on hormonal contraceptives unknown; add a barrier method

Pregnancy and breastfeeding

  • May cause foetal harm; highly effective contraception during and for up to 1 month after treatment, pregnancy test before starting

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 →

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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)

  • BrukinsaBeOne Medicines Ireland Limited · EMEA/H/C/004978

Source: European Medicines Agency (EMA), product information

Brand names in 2 more European countries
Iceland
Brukinsa
Norway
Brukinsa

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. Brukinsa – 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/brukinsa-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.