IDHIFA Film-coated tablet Ref.[10218] Active ingredients: Enasidenib

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

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

IDHIFA is available in the following tablet strengths:

  • 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.
How Supplied

50-mg tablet: Pale yellow to yellow oval-shaped film-coated tablet debossed “ENA” on one side and “50” on the other side.

  • 30-count bottles of 50-mg tablets with a desiccant canister (NDC 59572-705-30)

100-mg tablet: Pale yellow to yellow capsule-shaped film-coated tablet debossed “ENA” on one side and “100” on the other side.

  • 30-count bottles of 100-mg tablets with a desiccant canister (NDC 59572-710-30)

Manufactured for and marketed by: Celgene Corporation, Summit, NJ 07901

Licensed from: Agios Pharmaceuticals, Cambridge, MA 02139

Drugs

Drug Countries
IDHIFA Canada, 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.