A Framework for Fitness-for-Purpose and Reuse in Computational Phenotyping
November 17, 2025
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Brand Name :
IDHIFA
(United States) [Available]Synonyms :
Enasidenib
Class :
Antineoplastics and IDH2 Inhibitors
Brand Name :
IDHIFA
(United States) [Available]Synonyms :
Enasidenib
Class :
Antineoplastics and IDH2 Inhibitors
Dosage Forms & Strengths
Tablet
50mg
100mg
100
mg
Tablet
Oral
once a day
Continue the treatment until disease progression or unacceptable toxicity occurs    Patients without disease progression or unacceptable severe effects continue the treatment for six months to achieve clinical response
Safety and efficacy not established
Safety and efficacy are not studied
when both drugs are combined, there may be an increase in the serum concentration of alpelisib
when both drugs are combined, there may be an increase in the serum concentration of atogepant
when both drugs are combined, there may be an increase in the serum concentration of asunaprevir
when both drugs are combined, there may be an increase in the serum concentration of pazopanib
when both drugs are combined, there may be an increase in the serum concentrations of the active metabolite of revefenacin  
when both drugs are combined, there may be an increase in the serum concentration of digoxin
when both drugs are combined, there may be an increase in the serum concentration of talazoparib
it may diminish the metabolism when combined with azelastine
it may diminish the metabolism when combined with tiotropium
when bromazepam and enasidenib are used together, there is a potential reduction in the bromazepam's metabolism
When alprazolam and enasidenib is used together, this leads to reduction in the alprazolam’s metabolism
When dexrabeprazole and enasidenib is used together, this leads to reduction in the dexrabeprazole’s metabolism
When acetohexamide is used together with enasidenib, this lead to reduction in acetohexamide’s metabolism
When enasidenib is used together with somatotropin, this leads to a rise in enasidenib metabolism
When enasidenib is used together with oleandomycin, this leads to enhanced concentration serum of enasidenib
When enasidenib is used together with ridaforolimus, this leads to enhanced concentration serum of enasidenib
When enasidenib is used together with adenine, this leads to a reduction in the enasidenib's metabolism
the serum concentration of digitoxin is increased by enasidenib
may have a decrease in excretion when combined with enasidenib
When enasidenib is used together with lomitapide, this leads to an enhancement in lomitapide’s metabolism
Enasidenib selectively inhibits IDH2, an enzyme found in the mitochondria that is involved in several physiological functions, such as DNA modification, histone demethylation, and hypoxia adaption. Â
In the Krebs/citric acid cycle, wild-type IDH proteins are essential because they catalyze the oxidative decarboxylation of isocitrate to α-ketoglutarate.Â
Enasidenib has a greater potency against the mutant IDH2 variants R140Q, R172S, and R172K than it does against the wild type of enzyme from Label.Â
It reduced 2-hydroxyglutarate (2-HG) levels and the stimulation of appropriate myeloid lineage cell differentiation and clonal proliferation result from enzyme inhibition.Â
Frequency defined  Â
>10%  Â
Decreased serum calcium  Â
decreased serum potassium  Â
Nausea  Â
Diarrhea  Â
decreased appetite  Â
vomiting   Â
dysgeusia  Â
Abnormal phosphorus levels  Â
differentiation syndrome  Â
Leukocytosis  Â
Increased serum bilirubin  Â
1-10%  Â
Tumor lysis syndrome  Â
Acute respiratory distress  Â
Pulmonary edema  Â
Â
Differentiation syndrome symptoms, which can be lethal if left untreated, were reported by 14% of enasidenib-treated patients in the clinical trial.Â
There have been reports of differentiation syndrome as early as one day and as late as five months after starting enasidenib, both with and without concurrent hyperleukocytosis.Â
Corticosteroid treatment and hemodynamic monitoring should be started if differentiation syndrome is suspected and continued until the symptoms subside.Â
if severe renal failure and/or pulmonary symptoms that necessitate ventilator assistance or intubation continue for more than 48 hours following corticosteroid initiation.Â
Contraindication:Â
None Â
Caution:Â
Differentiation syndromeÂ
According to studies on the toxicity of animal embryosÂ
Potentially harm the fetus when given to expectant mothers.Â
Pregnancy warnings:    Â
Breastfeeding warnings: Â
Pregnancy Categories:      Â
Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first trimester or the later trimester.      Â
Category B: No evidence shown of risk to the fetus found in animal reproduction studies, and there are not enough studies on pregnant women      Â
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for a result in humans must take care of potential risks in pregnant women      Â
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits      Â
Category X: Drugs listed in this category outweigh risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.      Â
Category N: There is no data available for the drug under this category
Mouse xenograft models of IDH2 mutation AML showed reduced 2-hydroxyglutarate (2-HG) levels and myeloid development both in vitro and in vivo when enasidenib inhibited the mutant IDH2 enzyme.Â
Enasidenib therapy produced an overall response rate of 40.3% in a trial involving adult patients with relapsed or refractory AML. This response was linked to cellular maturation and differentiation without aplasia.Â
Open-label research assessed the possibility of QTc prolongation with enasidenib in patients with advanced hematologic malignancies.Â
It is taken orally in tablet form with or without food.Â
Take dose at the same time daily. Do not chew or split the tablet.Â
Swallow tablets whole at time with a cup of water.Â
If the next dose is almost here, take the current dose instead of the missed one.Â
Avoid taking two doses simultaneously.Â
Patient information leafletÂ
Generic Name: enasidenibÂ
Why do we use enasidenib? Â
Enasidenib is indicated for the treatment of relapsed or refractory acute myeloid leukemia (AML).Â
It is used to treat relapsed/refractory AML with an isocitrate dehydrogenase-2 (IDH2) mutation.Â
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