医薬品リファレンス
Voretigene neparvovec
Voretigene neparvovec is a medicine in the class miscellaneous.
- 薬効分類: Miscellaneous
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
- Miscellaneous
- ATCコード
- S01XA27
- 商品名
- 2
- 国・市場
- 2
作用のしくみ
Adeno-associated virus vector gene therapy that delivers a normal copy of the gene encoding human RPE65 to retinal cells in people with reduced or absent biologically active RPE65, restoring the visual cycle.
成人の通常用量（添付文書の要約）
Biallelic RPE65 mutation-associated retinal dystrophy: 1.5 x 10 11 vector genomes (vg) per eye, subretinal injection, total volume 0.3 mL; give each eye on separate days, no fewer than 6 days apart
妊娠と授乳
- 妊娠
- Unknown A one-time gene therapy injected under the retina for RPE65-related retinal dystrophy. No adequate human data and no animal reproduction studies (US). EU label: preferably avoid in pregnancy as a precaution. Germ-line transmission is considered highly unlikely.
- 授乳
- Unknown Not studied; not known if it passes into milk. Given once into the eye, with only brief low-level vector shedding in tears. No LactMed record. EU label: risk to the infant cannot be excluded, decide whether to stop breastfeeding; US label: weigh benefits.
報告されている副作用
- Conjunctival hyperemia
- Cataract
- Increased intraocular pressure
- Retinal tear
- Dellen (corneal stromal thinning)
- Macular hole
注意が必要な方
- Endophthalmitis may occur; use aseptic technique and monitor for infection.
- Permanent decline in visual acuity may occur; monitor for visual disturbances.
- Retinal abnormalities (macular holes, foveal thinning, chorioretinal atrophy, hemorrhage, tears, detachment) may occur; do not inject near the fovea.
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。
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、Voretigene neparvovec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
- IV preparation and dilution
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同じ分類のほかの薬剤
よくある質問
What is Voretigene neparvovec used for?
Voretigene neparvovec is a medicine in the class miscellaneous.
What side effects have been reported with Voretigene neparvovec?
Conjunctival hyperemia, Cataract, Increased intraocular pressure, Retinal tear, Dellen (corneal stromal thinning), Macular hole.
Can Voretigene neparvovec be taken in pregnancy or while breastfeeding?
Pregnancy: Unknown. A one-time gene therapy injected under the retina for RPE65-related retinal dystrophy. No adequate human data and no animal reproduction studies (US). EU label: preferably avoid in pregnancy as a precaution. Germ-line transmission is considered highly unlikely. Breastfeeding: Unknown. Not studied; not known if it passes into milk. Given once into the eye, with only brief low-level vector shedding in tears. No LactMed record. EU label: risk to the infant cannot be excluded, decide whether to stop breastfeeding; US label: weigh benefits.
What does Voretigene neparvovec interact with?
MediHelp does not list a checked interaction for Voretigene neparvovec yet. Always tell your pharmacist about every medicine you take.
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。
