Source: FDA, National Drug Code (US) Revision Year: 2020
INREBIC (fedratinib) is a kinase inhibitor with the chemical name N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide dihydrochloride monohydrate. Its empirical formula is C27H36N6O3S∙2HCl∙H2O and a molecular weight of 615.62. Fedratinib exhibits pH-dependent aqueous solubility; it is freely soluble in the acidic condition (>100 mg/mL at pH 1) and practically insoluble in the neutral condition (4 mcg/mL at pH 7.4).
The chemical structure is:
INREBIC (fedratinib) is available as 100-mg (equivalent to 117.3 mg of fedratinib dihydrochloride monohydrate) hard gelatin capsules for oral administration. Each capsule contains inactive ingredients of silicified microcrystalline cellulose and sodium stearyl fumarate. The capsule shell contains gelatin, red iron oxide, titanium dioxide and white ink.
| Dosage Forms and Strengths |
|---|
|
Capsules: 100 mg, reddish brown, opaque size 0, printed with “FEDR 100 mg” in white ink. |
| How Supplied |
|---|
|
INREBIC (fedratinib) 100 mg capsules: Reddish brown, opaque, size 0 capsule, printed with “FEDR 100 mg” in white ink.
|
| Drug | Countries | |
|---|---|---|
| INREBIC | Austria, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, 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.
