Brand Name

Brukinsa

Generic Name
Zanubrutinib
View Brand Information
FDA approval date: November 14, 2019
Classification: Kinase Inhibitor
Form: Tablet, Capsule

What is Brukinsa (Zanubrutinib)?

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma who have received at least one prior therapy.
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Brand Information

BRUKINSA (zanubrutinib)
1DOSAGE FORMS AND STRENGTHS
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.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling:
  • Hemorrhage
  • Infections
  • Cytopenias
  • Second Primary Malignancies
  • Cardiac Arrhythmias
  • Hepatotoxicity, including DILI
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data in the WARNINGS AND PRECAUTIONS reflect exposure to BRUKINSA in nine monotherapy and 2 combination clinical trials, administered at 160 mg twice daily in 1608 patients and at 320 mg once daily in 121 patients. Among these 1729 patients, the median duration of exposure was 27.6 months, 78% of patients were exposed for at least 12 months, and 60% of patients were exposed for at least 24 months.
In this pooled safety population, the most common adverse reactions (≥30%), including laboratory abnormalities, were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of BRUKINSA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Hepatobiliary disorder: drug-induced liver injury
4DESCRIPTION
BRUKINSA (zanubrutinib) is a kinase inhibitor. The empirical formula of zanubrutinib is C
The molecular weight of zanubrutinib is 471.55 Daltons.
Zanubrutinib has the following structure:
Chemical Structure
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.
Each BRUKINSA tablet for oral administration contains 160 mg zanubrutinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating contains FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, titanium dioxide, and triacetin.
5PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information).
6PRINCIPAL DISPLAY PANEL - 80 mg Capsule Carton
NDC 72579-011-02
Brukinsa
80 mg
Swallow capsules whole.
120 capsules
PRINCIPAL DISPLAY PANEL - 80 mg Capsule Carton
7PRINCIPAL DISPLAY PANEL - 160 mg Tablet Carton
Rx only
Brukinsa
160 mg
Swallow tablets whole.
60 tablets
PRINCIPAL DISPLAY PANEL - 160 mg Tablet Carton