Rx Item-BRUKINSA- zanubrutinib 80mg 120 capsules by Beigene USA

These highlights do not include all the information needed to use BRUKINSA safely and effectively. See full prescribing information for BRUKINSA.

BRUKINSA� (zanubrutinib) capsules, for oral use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE

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. (1)

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.
DOSAGE AND ADMINISTRATION

Recommended dose: 160 mg orally twice daily or 320 mg orally once daily; swallow whole with water and with or without food. (2.1)
Reduce BRUKINSA dose in patients with severe hepatic impairment. (2.2, 8.7)
Advise patients not to open, break, or chew capsules. (2.1)
Manage toxicity using treatment interruption, dose reduction, or discontinuation. (2.4)

DOSAGE FORMS AND STRENGTHS

Capsules: 80 mg. (3)
CONTRAINDICATIONS

None. (4)
WARNINGS AND PRECAUTIONS

Hemorrhage: Monitor for bleeding and manage appropriately. (5.1)

Infections: Monitor patients for signs and symptoms of infection, including opportunistic infections, and treat as needed. (5.2)

Cytopenias: Monitor complete blood counts during treatment. (5.3)

Second Primary Malignancies: Other malignancies have occurred in patients including skin cancers. Advise patients to use sun protection. (5.4)

Cardiac Arrhythmias: Monitor for atrial fibrillation and atrial flutter and manage appropriately. (5.5)

Embryo-Fetal Toxicity: Can cause fetal harm. Advise women of the potential risk to a fetus and to avoid pregnancy. (5.6)
ADVERSE REACTIONS

The most common adverse reactions (? 20%) included neutrophil count decreased, platelet count decreased, upper respiratory tract infection, white blood cell count decreased, hemoglobin decreased, rash, bruising, diarrhea and cough. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact BeiGene at 1-877-828-5596 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

CYP3A Inhibitors: Modify BRUKINSA dose with moderate or strong CYP3A inhibitors as described. (2.3, 7.1)
CYP3A Inducers: Avoid co-administration with moderate or strong CYP3A inducers. (7.1)

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 11/2019

Rx Item-BRUKINSA- zanubrutinib 80mg 120
RX72579-0011-02

Rx Item-BRUKINSA- zanubrutinib 80mg 120
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