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enasidenib (Idhifa)
Indications:
- refractory acute myeloid leukemia (AML) with mutations in the IDH2 gene
Contraindications:
- breast feeding
Dosage:
- 50-100 mg PO QD
- continue until disease progression or unacceptable toxicity
Tabs: 50 mg, 100 mg [2]
Adverse effects:
- nausea, vomiting, diarrhea
- increased serum bilirubin
- anorexia
* Boxed warning: differentiation syndrome [5]
Laboratory:
- approved for use with a companion diagnostic test
- RealTime IDH2 Assay (IDH2 gene mutation)
Mechanism of action:
- mutant isocitrate dehydrogenase-2 inhibitor
- associated with a complete remission of AML in some patients & a reduction in the need for both RBC transfusions & platelet transfusions
General
small inhibitory antineoplastic agent (ib drug)
Database Correlations
PUBCHEM correlations
References
- FDA News Release. August 1, 2017
FDA approves new targeted treatment for relapsed or refractory
acute myeloid leukemia.
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm569421.htm
- Windle ML.
FDA New Drug and Biologic Approvals -- 2017 Year-in-Review
Medscape - Jan 11, 2018.
https://reference.medscape.com/viewarticle/890871
- U.S. Food and Drug Administration.
Novel Drug Approvals for 2017.
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
- RxNorm
- Stein EM, DiNardo CD, Pollyea DA et al
Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia.
Blood. 2017 Aug 10;130(6):722-731. Epub 2017 Jun 6.
PMID: 28588020
- Wikipedia: Enasidenib
https://en.wikipedia.org/wiki/Enasidenib
- FDA Safety Announcement. Nov 29, 2018
FDA warns that symptoms of a serious condition affecting the
blood cells are not being recognized with the leukemia medicine
Idhifa (enasidenib).
https://www.fda.gov/Drugs/DrugSafety/ucm626923.htm