Leukemias, lymphomas, and other hematologic cancers:
Indications for: IDHIFA
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.
Adult Dosage:
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 Dosage:
Not established.
Boxed Warning:
Differentiation syndrome.
IDHIFA 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 Classification:
Isocitrate dehydrogenase-2 (IDH2) inhibitor.
IDHIFA Interactions:
Potentiates OATP1B1, OATP1B3, BCRP, and P-gp substrates. May increase or decrease concentrations of combined hormonal contraceptives.
Adverse Reactions:
Nausea, vomiting, diarrhea, elevated bilirubin, decreased appetite; differentiation syndrome, leukocytosis, tumor lysis syndrome.
Generic Drug Availability:
NO
How Supplied:
Tabs—30
