Dabrafenib (Tafinlar)
FDA approved 5/29/2013.
General information
Class/mechanism: BRAF kinase inhibitor. Dabrafenib inhibits some mutated BRAF kinases, such as BRAF V600E, BRAF V600K, and BRAF V600D. Some BRAF mutations such as BRAF V600E cause constitutive activation of the BRAF pathway, which drives tumor cell growth.[1][2]
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp,UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Dabrafenib (Tafinlar) package insert PDF pages 20-24[1]
- Patient counseling information can be found on page 18-19 of the Dabrafenib (Tafinlar) package insert[1]
History of changes in FDA indication
- 5/29/2013: FDA approved "for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test."[1]
Also known as
C23H20F3N5O2S2•CH4O3S, Dabrafenib mesylate, GSK2118436, N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzene sulfonamide, methanesulfonate salt.