enasidenib (Idhifa)
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Indications
- refractory acute myeloid leukemia (AML) with mutations in the IDH2 gene
Contraindications
Dosage
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
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
More general terms
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 - ↑ 2.0 2.1 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: https://www.ncbi.nlm.nih.gov/pubmed/28588020
- ↑ Wikipedia: Enasidenib https://en.wikipedia.org/wiki/Enasidenib
- ↑ 5.0 5.1 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