Référentiel des médicaments
Voretigene neparvovec
Voretigene neparvovec is a medicine in the class miscellaneous.
- Classe médicamenteuse: Miscellaneous
Dernière mise à jour Sources: US FDA label
Réservé aux professionnels de santé — à titre de référence uniquement. Cette page est un bref résumé, pas un avis médical, et ne remplace ni la notice officielle ni le jugement clinique. Vérifiez toujours avant de prescrire ou de délivrer.
Le contenu clinique de cette page n'est disponible qu'en anglais.
L'essentiel
- Classe médicamenteuse
- Miscellaneous
- Code ATC
- S01XA27
- Noms commerciaux
- 2
- Pays et marchés
- 2
Mécanisme d'action
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.
Posologie adulte habituelle (résumé de la notice)
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
Grossesse et allaitement
- Grossesse
- 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.
- Allaitement
- 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.
Effets indésirables signalés
- Conjunctival hyperemia
- Cataract
- Increased intraocular pressure
- Retinal tear
- Dellen (corneal stromal thinning)
- Macular hole
Précautions particulières
- 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.
Informez votre pharmacien ou votre médecin en cas de grossesse ou d'allaitement, de maladie rénale ou hépatique, d'allergies, ainsi que de tout autre médicament ou complément que vous prenez.
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- 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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Questions fréquentes
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.
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