Generic (Enasidenib) LuciEna

Enasidenib  is a medication used to treat relapsed or refractory acute myeloid leukemia (AML) in people with specific mutations of the isocitrate dehydrogenase 2 (IDH2) gene, determined by an FDA-approved IDH2 companion diagnostic test. It is an inhibitor of IDH2. 

Acute Myeloid Leukemia

Indicated for relapsed/refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation 

100 mg PO qDay until disease progression or unacceptable toxicity

In patients without disease progression or unacceptable toxicity, treat for ≥6 months to allow time for clinical response

Dosage Modifications

Differentiation syndrome

• If differentiation syndrome suspected, administer systemic corticosteroids; initiate hemodynamic monitoring
• Interrupt therapy if pulmonary symptoms (eg, intubation/ventilator support) and/or renal dysfunction persists for >48 hr post corticosteroid initiation
• Resume once signs/symptoms improve to Grade ≤2 (mild-moderate)

Noninfectious leukocytosis (WBC >30,000 mcL)

• Initiate hydroxyurea, as per standard institutional guidelines
• Interrupt therapy if no improvement of leukocytosis after initiating hydroxyurea
• Resume at 100 mg/day when WBC <30,000 mcL

Bilirubin elevated >3x ULN

• If sustained for ≥2 weeks without elevated AST/ALT or other hepatic disorders, reduce dose to 50 mg/day
• Resume at 100 mg/day if bilirubin elevation resolves to ≤2x ULN

Other Grade ≥3 toxicities (eg, tumor lysis syndrome)

• Interrupt therapy until toxicity resolve Grade ≤2
• If toxicities resolve (Grade ≤1), resume at 50 mg/day; may increase to 100 mg/day
• If Grade≥3 recurs, discontinue

Dosing Considerations

Monitoring parameters

• Assess baseline blood cell counts and chemistries for leukocytosis and tumor lysis syndrome before initiation; monitor at least q2week for at least first 3 months of treatment

Patient selection

• Select patients for treatment based on presence of IDH2 mutations in the blood and bone marrow