Source: FDA, National Drug Code (US) Revision Year: 2022
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 |
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Capsules: Each 80 mg capsule is a size 0, white to off-white opaque capsule marked with “ZANU 80” in black ink. |
How Supplied | ||||||
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Distributed and Marketed by: BeiGene USA, Inc., 2955 Campus Drive, Suite 200, San Mateo, CA 94403 |
Drug | Countries | |
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BRUKINSA | Austria, Cyprus, Ecuador, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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