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BTK Inhibitor Pregnancy: Can cause fetal harm based on findings in animals. Women should be advised to avoid pregnancy while taking it and to use effective contraception; advise of the potential risk to a fetus.

Zanubrutinib

Brand names: Brukinsa

Zanubrutinib is an oral Bruton tyrosine kinase (BTK) inhibitor used to treat B-cell malignancies including chronic lymphocytic leukaemia, Waldenstrom macroglobulinaemia, and certain other non-Hodgkin lymphomas.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 160 mg orally twice daily OR 320 mg orally once daily
Route: Oral
Frequency: Twice daily (160 mg) or once daily (320 mg)
Haematological-malignancy context (BRUKINSA; indicated for MCL, MZL, WM, CLL/SLL, FL). With or without food; swallow capsules whole with water (do not open, break or chew); tablets may be split in half as prescribed (do not chew or crush). For monotherapy or in combination with obinutuzumab, until disease progression or unacceptable toxicity. Severe hepatic impairment (Child-Pugh class C): 80 mg twice daily; no modification for mild or moderate impairment (Child-Pugh A or B). Dose modifications required with moderate/strong CYP3A inhibitors (reduce dose) and moderate CYP3A inducers (increase to 320 mg twice daily if unavoidable). Manage Grade 3 or higher haematological and non-haematological toxicity by treatment interruption, dose reduction or discontinuation. Safety and effectiveness in paediatric patients have not been established. (US labelling.)

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • None

Side effects

  • Neutrophil count decreased
  • Platelet count decreased
  • Upper respiratory tract infection
  • Haemorrhage/bleeding
  • Musculoskeletal pain

Interactions

  • Moderate and strong CYP3A inhibitors - increase zanubrutinib exposure; reduce zanubrutinib dose
  • Moderate and strong CYP3A inducers - decrease zanubrutinib exposure; avoid coadministration (if a moderate inducer cannot be avoided, increase dose to 320 mg twice daily)

Clinical monograph

How it works

It covalently binds and irreversibly inhibits Bruton tyrosine kinase, blocking B-cell receptor signalling needed for malignant B-cell proliferation and survival.

Prescribing in practice

  • Serious bleeding and haemorrhage can occur, so use caution with antiplatelet or anticoagulant therapy and consider withholding around surgery.
  • Cardiac arrhythmias including atrial fibrillation, cytopenias, infections and second primary malignancies are recognised risks requiring vigilance.
  • It is metabolised by CYP3A, so doses may need adjustment with strong CYP3A inhibitors or inducers.

Monitoring

Monitor the full blood count, for bleeding, infection and new arrhythmia such as atrial fibrillation, and review concomitant CYP3A-interacting drugs.

Counselling the patient

  • Report unusual bruising or bleeding, palpitations, fever or signs of infection.
  • Tell the team before any planned surgery or dental procedure.
  • Avoid grapefruit and check with the team before starting new medicines.

Evidence & guidelines

Zanubrutinib has demonstrated efficacy in chronic lymphocytic leukaemia and Waldenstrom macroglobulinaemia and is recommended by NICE for relevant indications.

Reference: ALPINE trial (Brown et al. NEJM 2023); NICE TA795; MHRA SPC Brukinsa; SEQUOIA trial (Tam et al. NEJM 2022); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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