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Valoctocogene roxaparvovec

Valoctocogene roxaparvovec is a medicine in the class miscellaneous. It is used for hemophilia a.

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
B02BD15
已知交互作用
40 (嚴重: 6 · 中度: 33 · 輕微: 1)
商品名
1
國家與市場
1

用途

作用方式

AAV5-based gene therapy vector that expresses B-domain deleted SQ recombinant human factor VIII (hFVIII-SQ) under a liver-specific promoter, replacing the missing factor VIII. Vector DNA forms episomal transgenes that support long-term hFVIII-SQ production.

成人常用劑量（仿單摘要）

Severe haemophilia A: 6 × 1013 vg/kg body weight, intravenous, as a single infusion. Dose volume in mL = body weight in kg multiplied by 3.

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 Gene therapy for men with severe haemophilia A. No pregnancy data or animal studies; theoretical risk of vector DNA reaching fetal cells. EU label: should not be used in pregnancy; not recommended in women who could become pregnant. Partners of treated men: double-barrier contraception for 6 months.
哺乳
Unknown Not known if the vector or factor VIII it produces passes into milk; no LactMed record. EU label: a risk to the infant cannot be excluded; should not be used while breastfeeding. It is licensed for men, so use while breastfeeding is not expected.

已通報的副作用

  • ALT increased
  • AST increased
  • LDH increased
  • CPK increased
  • Nausea
  • Headache

禁忌症

  • Hypersensitivity to the active substance or any excipient.
  • Active infections (acute or uncontrolled chronic), or known significant hepatic fibrosis or cirrhosis.

哪些人需要特別留意

  • Only for patients demonstrated to lack anti-AAV5 antibodies by a validated assay; not indicated with a history of factor VIII inhibitors.
  • Hepatic reactions (ALT increase) occur in most patients; monitor ALT and factor VIII activity and give corticosteroids as needed.
  • Infusion-related reactions can occur; monitor during and after infusion.

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 (40)

All 40 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 Valoctocogene roxaparvovec 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
  • Dosing in older adults
  • How to give it
  • Pharmacokinetics
  • Patient counselling points
  • Food interactions
  • IV preparation and dilution
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常見問題

What is Valoctocogene roxaparvovec used for?

Valoctocogene roxaparvovec is a medicine in the class miscellaneous. It is used for Hemophilia a.

What side effects have been reported with Valoctocogene roxaparvovec?

ALT increased, AST increased, LDH increased, CPK increased, Nausea, Headache.

Can Valoctocogene roxaparvovec be taken in pregnancy or while breastfeeding?

Pregnancy: Unsafe. Gene therapy for men with severe haemophilia A. No pregnancy data or animal studies; theoretical risk of vector DNA reaching fetal cells. EU label: should not be used in pregnancy; not recommended in women who could become pregnant. Partners of treated men: double-barrier contraception for 6 months. Breastfeeding: Unknown. Not known if the vector or factor VIII it produces passes into milk; no LactMed record. EU label: a risk to the infant cannot be excluded; should not be used while breastfeeding. It is licensed for men, so use while breastfeeding is not expected.

What does Valoctocogene roxaparvovec interact with?

MediHelp lists 40 known interactions for Valoctocogene roxaparvovec. Major: 6 · Moderate: 33 · Minor: 1. The most serious include Dantrolene, Efavirenz, Flutamide.

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