BRUKINSA Capsule Ref.[49875] Active ingredients: Zanubrutinib

Source: FDA, National Drug Code (US)  Revision Year: 2022 

Product description

BRUKINSA (zanubrutinib) is a kinase inhibitor. The empirical formula of zanubrutinib is C27H29N5O3 and the chemical name is (S)7(1-acryloylpiperidin-4-yl)2(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo[1,5-a]pyrimidine-3-carboxamide. Zanubrutinib is a white to off-white powder, with a pH of 7.8 in saturated solution. The aqueous solubility of zanubrutinib is pH dependent, from very slightly soluble to practically insoluble.

The molecular weight of zanubrutinib is 471.55 Daltons.

Zanubrutinib has the following 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.

Dosage 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.

How Supplied
Package Size Content NDC Number
120-count Bottle with a child-resistant cap containing 120 capsules
80 mg, white to off-white opaque capsule, marked with “ZANU 80” in black ink
72579-011-02

Distributed and Marketed by: BeiGene USA, Inc., 2955 Campus Drive, Suite 200, San Mateo, CA 94403

Drugs

Drug Countries
BRUKINSA Austria, Cyprus, Ecuador, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States

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