Riferimento farmaci
Voretigene neparvovec
Voretigene neparvovec is a medicine in the class miscellaneous.
- Classe del farmaco: Miscellaneous
Ultimo aggiornamento Fonti: US FDA label
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In breve
- Classe del farmaco
- Miscellaneous
- Codice ATC
- S01XA27
- Nomi commerciali
- 2
- Paesi e mercati
- 2
Come agisce
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.
Dose abituale nell'adulto (sintesi del foglio illustrativo)
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
Gravidanza e allattamento
- Gravidanza
- 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.
- Allattamento
- 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.
Effetti indesiderati segnalati
- Conjunctival hyperemia
- Cataract
- Increased intraocular pressure
- Retinal tear
- Dellen (corneal stromal thinning)
- Macular hole
Chi deve prestare attenzione
- 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.
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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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Domande frequenti
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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