Référentiel des médicaments
Enasidenib
Enasidenib is a medicine in the class oncology.
- Classe médicamenteuse: Oncology
Dernière mise à jour Sources: US FDA label
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L'essentiel
- Classe médicamenteuse
- Oncology
- Formes courantes
- comprimé
- Interactions connues
- 5 (Majeure: 1 · Modérée: 4)
- Noms commerciaux
- 1
- Pays et marchés
- 1
Mécanisme d'action
Small molecule inhibitor of isocitrate dehydrogenase 2 (IDH2); targets mutant IDH2 variants R140Q, R172S and R172K, decreasing 2-hydroxyglutarate levels and inducing myeloid differentiation.
Posologie adulte habituelle (résumé de la notice)
Relapsed or refractory AML with IDH2 mutation: 100 mg orally once daily with or without food until disease progression or unacceptable toxicity; treat for a minimum of 6 months in patients without progression or unacceptable toxicity to allow clinical response
Grossesse et allaitement
- Grossesse
- Unsafe Can cause fetal harm: in rats and rabbits it caused embryo-fetal death and growth changes from 0.1 times human exposure; no human data. Verify pregnancy status. Use effective contraception during and for 2 months after; it can make hormonal pills less effective.
- Allaitement
- Unsafe No milk data. Because of possible adverse reactions in the infant, do not breastfeed during treatment and for 2 months after the last dose.
Effets indésirables signalés
- Nausea
- Diarrhea
- Vomiting
- Decreased appetite
- Elevated bilirubin
- Differentiation syndrome
Mises en garde encadrées
- Differentiation syndrome 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 suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
Contre-indications
- None.
Précautions particulières
- Differentiation syndrome occurred in 14% of patients, as early as 1 day and up to 5 months after initiation; treat with corticosteroids (e.g., dexamethasone 10 mg every 12 hours) and hemodynamic monitoring; taper only after symptom resolution.
- Embryo-fetal toxicity: can cause fetal harm; verify pregnancy status before starting and use effective non-hormonal contraception during treatment and for 2 months after the last dose.
- Elevated bilirubin due to UGT1A1 inhibition; 37% of patients had total bilirubin ≥2 x ULN at least once.
Informez votre pharmacien ou votre médecin en cas de grossesse ou d'allaitement, de maladie rénale ou hépatique, d'allergies, ainsi que de tout autre médicament ou complément que vous prenez.
Principales interactions (5)
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- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- Dosing in older adults
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- Patient counselling points
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Questions fréquentes
What is Enasidenib used for?
Enasidenib is a medicine in the class oncology.
What side effects have been reported with Enasidenib?
Nausea, Diarrhea, Vomiting, Decreased appetite, Elevated bilirubin, Differentiation syndrome. Serious warning: Differentiation syndrome can be fatal if not treated.
Can Enasidenib be taken in pregnancy or while breastfeeding?
Pregnancy: Unsafe. Can cause fetal harm: in rats and rabbits it caused embryo-fetal death and growth changes from 0.1 times human exposure; no human data. Verify pregnancy status. Use effective contraception during and for 2 months after; it can make hormonal pills less effective. Breastfeeding: Unsafe. No milk data. Because of possible adverse reactions in the infant, do not breastfeed during treatment and for 2 months after the last dose.
What does Enasidenib interact with?
MediHelp lists 5 known interactions for Enasidenib. Major: 1 · Moderate: 4. The most serious include Rosuvastatin, Desogestrel-ethinyl estradiol, Ethinyl estradiol-levonorgestrel.
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