Idhifa

— THERAPEUTIC CATEGORIES —
  • Leukemias, lymphomas, and other hematologic cancers

Idhifa Generic Name & Formulations

General Description

Enasidenib 50mg, 100mg; tabs.

Pharmacological Class

Isocitrate dehydrogenase-2 (IDH2) inhibitor.

How Supplied

Tabs—30

Manufacturer

Generic Availability

NO

Idhifa Indications

Indications

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

Adult

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.

Children

Not established.

Idhifa Contraindications

Not Applicable

Idhifa Boxed Warnings

Boxed Warning

Differentiation syndrome.

Idhifa Warnings/Precautions

Warnings/Precautions

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).

Idhifa Pharmacokinetics

See Literature

Idhifa Interactions

Interactions

Potentiates OATP1B1, OATP1B3, BCRP, and P-gp substrates. May increase or decrease concentrations of combined hormonal contraceptives.

Idhifa Adverse Reactions

Adverse Reactions

Nausea, vomiting, diarrhea, elevated bilirubin, decreased appetite; differentiation syndrome, leukocytosis, tumor lysis syndrome.

Idhifa Clinical Trials

See Literature

Idhifa Note

Not Applicable

Idhifa Patient Counseling

See Literature

Images