医薬品リファレンス
Enasidenib
Enasidenib is a medicine in the class oncology.
- 薬効分類: Oncology
最終更新日 出典: US FDA label
医療従事者向け・参照専用。このページは簡潔な要約であり、医学的助言ではなく、公式の添付文書や臨床判断に代わるものではありません。処方・調剤の前に必ず確認してください。
このページの臨床コンテンツは英語でのみ提供されています。
要点
- 薬効分類
- Oncology
- 一般的な剤形
- 錠剤
- 既知の相互作用
- 5 (重大: 1 · 中等度: 4)
- 商品名
- 1
- 国・市場
- 1
作用のしくみ
Small molecule inhibitor of isocitrate dehydrogenase 2 (IDH2); targets mutant IDH2 variants R140Q, R172S and R172K, decreasing 2-hydroxyglutarate levels and inducing myeloid differentiation.
成人の通常用量(添付文書の要約)
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
妊娠と授乳
- 妊娠
- 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.
- 授乳
- 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.
報告されている副作用
- Nausea
- Diarrhea
- Vomiting
- Decreased appetite
- Elevated bilirubin
- Differentiation syndrome
警告(枠囲み警告)
- 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.
禁忌
- None.
注意が必要な方
- 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.
妊娠中または授乳中であること、腎臓や肝臓の病気、アレルギー、ほかに使用しているすべての薬やサプリメントについて、薬剤師または医師にお伝えください。
主な相互作用 (5)
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アカウントを作成してPro+トライアルを始めると、Enasidenibの完全なモノグラフ(用量、妊娠・授乳、副作用、警告、すべての相互作用)を表示できます。
- 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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同じ分類のほかの薬剤
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よくある質問
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.
完全なモノグラフ、用量、相互作用チェッカーはMediHelpアプリで
MediHelpアプリで、完全なリファレンスを開き、複数薬剤の相互作用をチェックし、用量ツールを利用できます。