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 |
|---|
|
Capsules: Each 80 mg capsule is a size 0, white to off-white opaque capsule marked with “ZANU 80” in black ink. |
| How Supplied | ||||||
|---|---|---|---|---|---|---|
Distributed and Marketed by: BeiGene USA, Inc., 2955 Campus Drive, Suite 200, San Mateo, CA 94403 |
| Drug | Countries | |
|---|---|---|
| BRUKINSA | Ecuador, Estonia, Croatia, Ireland, Israel, Poland, Romania, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
