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Valoctocogene roxaparvovec

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

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
B02BD15
既知の相互作用
40 (重大: 6 · 中等度: 33 · 軽度: 1)
商品名
1
国・市場
1

何に使われるか

作用のしくみ

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.

成人の通常用量（添付文書の要約）

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.

添付文書の最初の用法・用量の行のみの要約です。用法・用量の全項目はアプリでご覧いただけます。

妊娠と授乳

妊娠
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.
授乳
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.

報告されている副作用

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

禁忌

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

注意が必要な方

  • 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.

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 (40)

All 40 interactions, with severity and what to do

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、Valoctocogene roxaparvovec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
  • IV preparation and dilution
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よくある質問

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.

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。

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