Brukinsa

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).
• Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.
  
  This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

• Recommended dosage: 160 mg orally twice daily or 320 mg orally once daily with or without food; swallow whole with water.
• Tablets can be split in half as prescribed by the healthcare provider.
• Reduce BRUKINSA dose in patients with severe hepatic impairment.
• Advise patients not to open, break, or chew capsules.
• Advise patients not to chew or crush tablets.
• Manage toxicity using treatment interruption, dose reduction, or discontinuation.

Capsules: Each 80 mg capsule is a size 0, white to off-white opaque capsule marked with "ZANU 80" in black ink.

Tablets: 160 mg, blue, oval, film-coated tablets debossed with "zanu" on one side and functional scoring on the other side.

Lactation: Advise not to breastfeed.