医薬品リファレンス
Leniolisib
Leniolisib is a medicine in the class miscellaneous.
- 薬効分類: Miscellaneous
最終更新日 出典: EMA SmPC
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
- Miscellaneous
- ATCコード
- L03AX22
- 一般的な剤形
- 錠剤
- 既知の相互作用
- 97 (重大: 17 · 中等度: 61 · 軽度: 19)
- 商品名
- 2
- 国・市場
- 2
作用のしくみ
Selectively inhibits PI3K delta by blocking its active binding site. This reduces PIP3 production and the hyperactive Akt/mTOR signalling seen in APDS, so B and T cell populations normalise.
成人の通常用量（添付文書の要約）
APDS (adults and adolescents 12 years and older weighing 45 kg or more): 70 mg orally twice daily, approximately 12 hours apart; continue while benefit is observed or until unacceptable toxicity
妊娠と授乳
- 妊娠
- Unsafe No human data; animal studies showed reproductive toxicity and leniolisib can cause foetal harm. Not recommended in pregnancy or in women of childbearing potential not using highly effective contraception.
- 授乳
- Unsafe Excretion in human milk unknown; animal data show excretion in milk and risk to infants cannot be excluded. Breast-feeding should be discontinued during treatment.
報告されている副作用
- Headache
- Vomiting
- Weight increased
- Alopecia
- Neutrophil count decreased
- Dyspepsia
禁忌
- Hypersensitivity to the active substance or any excipient.
注意が必要な方
- Serious immune-related adverse events (severe infections, SCARs, pneumonitis, colitis, hepatotoxicity) occurred with other PI3K delta inhibitors in cancer patients; not associated with Joenja in APDS.
- Avoid strong CYP3A4 inhibitors, which increase leniolisib exposure.
- Avoid strong and moderate CYP3A4 inducers, which may reduce efficacy.
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 (97)
- Amobarbital + Leniolisib Major
- Apalutamide + Leniolisib Major
- Carbamazepine + Leniolisib Major
- Clarithromycin + Leniolisib Major
- Cyclosporin + Leniolisib Major
- Efavirenz + Leniolisib Major
- Enzalutamide + Leniolisib Major
- Itraconazole + Leniolisib Major
- Ketoconazole + Leniolisib Major
- Leniolisib + Modafinil Major
Pro+会員向け
ページ全体を見る
アカウントを作成してPro+トライアルを始めると、Leniolisib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
- Paediatric dosing
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
- Food interactions
WebでPro+を14日間無料でお試し。カード登録不要。
よくある質問
What is Leniolisib used for?
Leniolisib is a medicine in the class miscellaneous.
What side effects have been reported with Leniolisib?
Headache, Vomiting, Weight increased, Alopecia, Neutrophil count decreased, Dyspepsia.
Can Leniolisib be taken in pregnancy or while breastfeeding?
Pregnancy: Unsafe. No human data; animal studies showed reproductive toxicity and leniolisib can cause foetal harm. Not recommended in pregnancy or in women of childbearing potential not using highly effective contraception. Breastfeeding: Unsafe. Excretion in human milk unknown; animal data show excretion in milk and risk to infants cannot be excluded. Breast-feeding should be discontinued during treatment.
What does Leniolisib interact with?
MediHelp lists 97 known interactions for Leniolisib. Major: 17 · Moderate: 61 · Minor: 19. The most serious include Amobarbital, Apalutamide, Carbamazepine.
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。
