Enasidenib is an isocitrate dehydrogenase 2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. MedsAcross supplies Enasidenib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
Source: US FDA prescribing information
Enasidenib is a small molecule inhibitor of the isocitrate dehydrogenase 2 (IDH2) enzyme. Enasidenib targets the mutant IDH2 variants R140Q, R172S, and R172K at approximately 40-fold lower concentrations than the wild-type enzyme in vitro. Inhibition of the mutant IDH2 enzyme by enasidenib led to decreased 2-hydroxyglutarate (2-HG) levels and induced myeloid differentiation in vitro and in vivo in mouse xenograft models of IDH2 mutated AML. In blood samples from patients with AML with mutated IDH2, enasidenib decreased 2-HG levels, reduced blast counts and increased percentages of mature myeloid cells.
Source: US FDA prescribing information
100 mg orally once daily until disease progression or unacceptable toxicity. Patient Selection Select patients for the treatment of AML with IDHIFA based on the presence of IDH2 mutations in the blood or bone marrow. Information on FDA-approved tests for the detection of IDH2 mutations in AML is available at http://www.fda.gov/CompanionDiagnostics.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (differentiation syndrome): Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. Embryo-Fetal Toxicity: IDHIFA can cause fetal harm. Advise patients of the potential risk to a fetus and use effective contraception.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: • Differentiation Syndrome The most common adverse reactions (≥20%) are nausea, vomiting, diarrhea, elevated bilirubin, and decreased appetite.
Source: US FDA prescribing information
• Certain CYP1A2 and CYP2C19 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information. • Certain CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information. • Certain OATP1B1, OATP1B3, and BCRP Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information.
Source: US FDA prescribing information
Storage Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C-30°C (59°F-86°F). Store and dispense in the original bottle (with a desiccant canister) to protect from moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Enasidenib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Idhifa 100 mg tabletOral | Celgene | US FDA | Available on request |
| Idhifa 50 mg tabletOral | Celgene | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 1 August 2017 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Enasidenib in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Enasidenib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Enasidenib, including Idhifa.
Yes. The US FDA first approved Enasidenib on 1 August 2017, according to Drugs@FDA.
No listed presentation of Enasidenib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Enasidenib is classified under ATC code L01XX59 (Enasidenib).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.