Brukinsa
Brukinsa ingredients
| Active ingredient | Strength |
|---|---|
| Zanubrutinib | 160 mg/1, 80 mg/1 |
What Brukinsa is used for
The FDA lists the approved uses on the official label (below). In the EU, zanubrutinib is approved as Brukinsa for:
Brukinsa as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. Brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. Brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL). Brukinsa in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Brukinsa
- Generic name
- Zanubrutinib
- Made by
- BeOne Medicines USA, Inc.
- Forms
- Capsule, Tablet, Film Coated
- Given
- Oral
- Drug class
- Kinase Inhibitor
- FDA approval
- New drug application (NDA) NDA218785
- On the US market since
- 2019
Official information
- MedlinePlus drug information (search for Zanubrutinib)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Brukinsa?
Brukinsa (Zanubrutinib) is a cancer medicine made by BeOne Medicines USA, Inc., approved by the US FDA.
What are the ingredients of Brukinsa?
Brukinsa contains Zanubrutinib (160 mg/1, 80 mg/1).
Is Brukinsa approved in Europe?
The same active substance is approved in the EU as Brukinsa.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA