Source: FDA, National Drug Code (US) Revision Year: 2020
IDHIFA (enasidenib) is an inhibitor of isocitrate dehydrogenase-2 (IDH2) enzyme. Enasidenib is available as the mesylate salt with the chemical name:
2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]6{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate.
Or
2-Propanol,2-methyl-1-[[4-[6-(trifluoromethyl)-2-pyridinyl]6[[2-(trifluoromethyl)-4-pyridinyl]amino-1,3,5-triazin-2-yl]amino]-, methanesulfonate (1:1).
The chemical structure is:
The empirical formula is C19H17F6N7O • CH3SO3H (C20H21F6N7O4S), and the molecular weight is 569.48 g/mol. Enasidenib is practically insoluble (solubility ≤74 mcg/mL) in aqueous solutions across physiological pH range (pH 1.2 and 7.4).
IDHIFA (enasidenib) is available as a 50-mg tablet (equivalent to 60 mg enasidenib mesylate) and a 100-mg tablet (equivalent to 120 mg enasidenib mesylate) for oral administration. Each tablet contains inactive ingredients of colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose acetate succinate, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, sodium starch glycolate, talc, and titanium dioxide.
Dosage Forms and Strengths |
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IDHIFA is available in the following tablet strengths:
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How Supplied |
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50-mg tablet: Pale yellow to yellow oval-shaped film-coated tablet debossed “ENA” on one side and “50” on the other side.
100-mg tablet: Pale yellow to yellow capsule-shaped film-coated tablet debossed “ENA” on one side and “100” on the other side.
Manufactured for and marketed by: Celgene Corporation, Summit, NJ 07901 Licensed from: Agios Pharmaceuticals, Cambridge, MA 02139 |
Drug | Countries | |
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IDHIFA | Canada, United States |
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