Riferimento farmaci
Enasidenib
Enasidenib is a medicine in the class oncology.
- Classe del farmaco: Oncology
Ultimo aggiornamento Fonti: US FDA label
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In breve
- Classe del farmaco
- Oncology
- Forme farmaceutiche comuni
- compressa
- Interazioni note
- 5 (Maggiore: 1 · Moderata: 4)
- Nomi commerciali
- 1
- Paesi e mercati
- 1
Come agisce
Small molecule inhibitor of isocitrate dehydrogenase 2 (IDH2); targets mutant IDH2 variants R140Q, R172S and R172K, decreasing 2-hydroxyglutarate levels and inducing myeloid differentiation.
Dose abituale nell'adulto (sintesi del foglio illustrativo)
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
Gravidanza e allattamento
- Gravidanza
- 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.
- Allattamento
- 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.
Effetti indesiderati segnalati
- Nausea
- Diarrhea
- Vomiting
- Decreased appetite
- Elevated bilirubin
- Differentiation syndrome
Avvertenze in evidenza
- 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.
Controindicazioni
- None.
Chi deve prestare attenzione
- 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.
Informare il farmacista o il medico di gravidanza o allattamento, malattie renali o epatiche, allergie e di ogni altro farmaco o integratore assunto.
Interazioni principali (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
- How to give it
- Pharmacokinetics
- Patient counselling points
- Food interactions
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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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