BRUKINSA (zanubrutinib) is a kinase inhibitor.Each BRUKINSA capsule for oral administration contains 80 mg zanubrutinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The capsule shell contains edible black ink,
gelatin, and titanium dioxide.
BRUKINSA (zanubrutinib) Capsule - 160 mg or 320 mg
*Recommended dosage: 160 mg orally twice daily or 320 mg orally once
daily; swallow whole with water and with or without food.
• Reduce BRUKINSA dose in patients with severe hepatic impairment.
• Advise patients not to open, break, or chew capsules.
BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients
with:
• Mantle cell lymphoma (MCL) who have received at least one prior therapy.This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in a confirmatory trial.
• Waldenström’s macroglobulinemia (WM).
• Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen.
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).