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Leniolisib

Leniolisib is a medicine in the class miscellaneous.

  • 藥物類別: Miscellaneous

最後更新 來源: EMA SmPC

僅供醫療專業人員參考。本頁為簡要摘要,並非醫療建議,亦不能取代官方仿單或臨床判斷。開立處方或調劑前請務必核實。

本頁的臨床內容僅提供英文版。

重點資訊

藥物類別
Miscellaneous
ATC 代碼
L03AX22
常見劑型
錠劑
已知交互作用
97 (嚴重: 17 · 中度: 61 · 輕微: 19)
商品名
2
國家與市場
2

劑型、規格與商品名稱會因國家而異。請核對您手上的產品。

作用方式

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.

成人常用劑量(仿單摘要)

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

僅摘錄仿單中第一行劑量說明;完整的劑量內容請見 App。

懷孕與哺乳

懷孕
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.
哺乳
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.

已通報的副作用

  • Headache
  • Vomiting
  • Weight increased
  • Alopecia
  • Neutrophil count decreased
  • Dyspepsia

禁忌症

  • Hypersensitivity to the active substance or any excipient.

哪些人需要特別留意

  • 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.

請告知藥師或醫師您是否懷孕或哺乳、是否患有腎臟或肝臟疾病、是否有過敏,以及您正在使用的所有其他藥物或保健品。

重要交互作用 (97)

All 97 interactions, with severity and what to do

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解鎖完整頁面

建立帳號並開始 Pro+ 試用,即可開啟 Leniolisib 的完整藥品專論:劑量、懷孕與哺乳、副作用、警示及所有交互作用。

  • 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

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常見問題

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.

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