Drug Detail:Enasidenib (Enasidenib [ en-a-sid-a-nib ])
Drug Class: Miscellaneous antineoplastics
Usual Adult Dose for Acute Myeloid Leukemia
100 mg orally once a day with or without food
Duration of Therapy:
- Treat until disease progression or unacceptable toxicity.
- For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response.
Comments: Select patients based on the presence of isocitrate dehydrogenase-2 (IDH2) mutations in the blood or bone marrow as detected by an FDA-approved test, http://www.fda.gov/CompanionDiagnostics.
Use: Treatment of relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation.
Renal Dose Adjustments
Data not available.
Liver Dose Adjustments
Data not available.
HEPATOTOXICITY DURING TREATMENT:
Bilirubin Elevation Greater Than 3 Times the Upper Limit Of Normal (ULN) Sustained For 2 Weeks Or More (without elevated transaminases or other hepatic disorders):
- Reduce dose to 50 mg/day.
- Resume treatment at 100 mg/day if bilirubin elevation resolves to less than 2 x ULN.
Dose Adjustments
MANAGING TOXICITIES:
Differentiation Syndrome:
- If differentiation syndrome is suspected, administer systemic corticosteroids and initiate hemodynamic monitoring.
- Interrupt treatment if severe pulmonary symptoms requiring intubation or ventilator support, and/or renal dysfunction persist for more than 48 hours after initiation of corticosteroids.
- Resume treatment when signs/symptoms improve to Grade 2 or lower.
Noninfectious Leukocytosis [white blood cell (WBC) count greater than 30 x 10(9)/L]:
- Initiate hydroxyurea, as per standard institutional practices.
- Interrupt enasidenib if leukocytosis is not improved with hydroxyurea, and then resume enasidenib at 100 mg daily when WBC is less than 30 x 10(9)/L.
Other Treatment-Related Grade 3 or Higher Toxicity (e.g., tumor lysis syndrome):
- Interrupt treatment until toxicity resolves to Grade 2 or lower.
- Resume treatment at 50 mg/day; may increase to 100 mg/day if toxicities resolve to Grade 1 or lower.
- Discontinue treatment if Grade 3 or higher toxicity recurs.
Precautions
US BOXED WARNING: Patients treated with this drug have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available.
Frequently asked questions
- What is Idhifa used to treat?
