Idhifa Generic Name & Formulations
Enasidenib 50mg, 100mg; tabs.
Isocitrate dehydrogenase-2 (IDH2) inhibitor.
Treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
Idhifa Dosage and Administration
Swallow whole. Take at same time each day. Initially 100mg once daily until disease progression or unacceptable toxicity; treat for a minimum of 6 months to allow time for response. Monitoring and dose modifications for toxicities: see full labeling.
Idhifa Boxed Warnings
Risk of differentiation syndrome (may be fatal if not treated). If differentiation syndrome is suspected, initiate oral or IV corticosteroids and hemodynamic monitoring until resolution; interrupt dose if severe pulmonary symptoms requiring intubation or ventilator support, and/or renal dysfunction persist >48hrs after corticosteroid initiation. Assess blood counts/chemistries for leukocytosis and tumor lysis syndrome prior to initiation; monitor at minimum of every 2 weeks for at least the first 3 months during therapy. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for at least 2 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for at least 2 months after the last dose).
Potentiates OATP1B1, OATP1B3, BCRP, and P-gp substrates. May increase or decrease concentrations of combined hormonal contraceptives.
Idhifa Adverse Reactions
Nausea, vomiting, diarrhea, elevated bilirubin, decreased appetite; differentiation syndrome, leukocytosis, tumor lysis syndrome.
Idhifa Clinical Trials
Idhifa Patient Counseling