IMPORTANT SAFETY INFORMATION
INDICATIONS AND CLINICAL USE:
BRUKINSA (zanubrutinib) is indicated:
- for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).
- for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
- for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.
- for the treatment of adult patients with chronic lymphocytic leukemia (CLL).
BRUKINSA is contraindicated in patients who are hypersensitive to zanubrutinib or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Most Serious Warnings and Precautions:
OTHER RELEVANT WARNINGS AND PRECAUTIONS:
Second primary malignancies:
Monitor patients for skin cancer and advise patients to use sun protection.
Atrial fibrillation and flutter:
Monitor for signs and symptoms of atrial fibrillation and atrial flutter and manage as appropriate.
Driving and operating machinery:
Fatigue, dizziness, and asthenia have been reported in some patients taking BRUKINSA and should be considered when assessing a patient’s ability to drive or operate machines.
Monitor complete blood counts regularly during treatment.
Monitor patients for signs and symptoms of infection and treat appropriately. Consider prophylaxis according to standard of care in patients who are at increased risk for infections.
Tumour lysis syndrome:
Monitor patients closely and treat as appropriate.
Consider the benefit-risk of withholding BRUKINSA for 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.
No data on the effects of BRUKINSA on fertility in humans are available.
Advise women of the potential hazard to a fetus and to avoid becoming pregnant during treatment and for at least 1 week after the last dose of BRUKINSA. Advise men to avoid fathering a child while receiving BRUKINSA and for at least 3 months following the last dose of BRUKINSA.
Advise lactating women not to breastfeed during treatment with BRUKINSA and for at least two weeks following the last dose.
Interstitial lung disease (ILD):
Monitor patients for signs and symptoms of ILD.
Patients should be monitored for signs of bleeding.
For more information:
Please consult the BRUKINSA
for important information relating to adverse reactions, drug interactions, and dosing information, which has not been discussed in this piece. The Product Monograph is also available by calling