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Brukinsa Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Brukinsa Indications
Indications
Mantle cell lymphoma (MCL) in adults who have received at least one prior therapy. Waldenström’s macroglobulinemia (WM) in adults. Relapsed or refractory marginal zone lymphoma (MZL) in adults who have received at least one anti-CD20-based regimen. Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults. In combination with obinutuzumab for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after ≥2 lines of systemic therapy.
Brukinsa Dosage and Administration
Adult
Swallow whole with water. 160mg twice daily or 320mg once daily until disease progression or unacceptable toxicity. Severe hepatic impairment: 80mg twice daily. Concomitant clarithromycin 500mg twice daily, posaconazole susp >100mg/day, posaconazole del-rel tabs or IV 300mg/day, other strong CYP3A inhibitors: 80mg once daily. Concomitant clarithromycin 250mg twice daily, posaconazole susp 100mg/day, moderate CYP3A inhibitors: 80mg twice daily. Concomitant moderate CYP3A inducers (if unavoidable): increase dose to 320mg twice daily. Dose modifications for adverse reactions: see full labeling.
Children
Brukinsa Contraindications
Not Applicable
Brukinsa Boxed Warnings
Not Applicable
Brukinsa Warnings/Precautions
Warnings/Precautions
Risk for serious hemorrhagic events (monitor); consider the benefit/risk of withholding treatment for 3–7 days pre- and post-surgery. Monitor for fever, infections; treat appropriately if occurs. Consider prophylaxis for opportunistic infections in high risk patients. Monitor for cytopenias; obtain CBCs during therapy; interrupt, reduce dose, or discontinue as warranted. Monitor for cardiac arrhythmias (esp. in those with cardiac risk factors, hypertension, acute infections); manage appropriately. Second primary malignancies (eg, skin cancer, solid tumors, hematologic, others); advise to use sun protection; monitor. On dialysis, hepatic impairment: monitor. Embryo-fetal toxicity. Advise females and males of reproductive potential to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).
Brukinsa Pharmacokinetics
Absorption
Median time to maximum concentration: 2 hours.
Distribution
Volume of distribution: 537 L. Plasma protein bound: ~94%.
Elimination
Fecal (87%), renal (8%). Mean half-life: ~2–4 hours. Clearance: 128 L/h.
Brukinsa Interactions
Interactions
Concomitant moderate or strong CYP3A inducers may reduce zanubrutinib efficacy (eg, rifampin, efavirenz); avoid use. If concomitant moderate CYP3A inducers is unavoidable, increase zanbrutinib dose (see Adults). Concomitant moderate or strong CYP3A inhibitors may increase risk of toxicities (eg, itraconazole, fluconazole, erythromycin); reduce zanubrutinib dose (see Adults). Increased risk of hemorrhage with concomitant antiplatelets or anticoagulants; monitor.
Brukinsa Adverse Reactions
Adverse Reactions
Brukinsa Clinical Trials
See Literature
Brukinsa Note
Not Applicable
Brukinsa Patient Counseling
See Literature
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