SPL Set ID: 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86

VANFLYTA (quizartinib) is a kinase inhibitor for oral use. The chemical name of quizartinib dihydrochloride is 1-(5- tert -butyl-1,2-oxazol-3-yl)-3-(4-{7-[2-(morpholin-4-yl)ethoxy]imidazo[2,1-b][1,3]benzothiazol-2-yl}phenyl)urea dihydrochloride. Quizartinib dihydrochloride is a white to off-white solid with a molecular formula of C 29 H 32 N 6 O 4 S∙2 HCl and a molecular weight of 633.6 for the salt and 560.7 for the free base. The aqueous solubility of quizartinib dihydrochloride (pKa 4.75 and 3.16) decreases with increasing pH. It is very slightly soluble in aqueous media at pH 1 and practically insoluble or insoluble at pH 2 and higher. Quizartinib dihydrochloride is very slightly soluble in ethanol. The chemical structure of quizartinib dihydrochloride is: VANFLYTA is supplied as film-coated tablets containing 17.7 mg or 26.5 mg of quizartinib, which are equivalent to 20 mg and 30 mg quizartinib dihydrochloride, respectively. The inactive ingredients in the tablet core are hydroxypropyl betadex, microcrystalline cellulose, and magnesium stearate. The tablet coating consists of hypromellose, talc, triacetin, and titanium dioxide. The 26.5 mg tablet coating also contains ferric oxide. Chemical Structure