Voretigene neparvovec interacts in the following cases:
Intraocular pressure should be monitored prior to and following administration of the medicinal product and managed appropriately. Patients should be instructed to avoid air travel or other travel to high elevations until the air bubble formed as a result of administration of voretigene neparvovec has completely dissipated from the eye. A time period of up to one week or more following injection may be required before dissipation of the air bubble; this should be verified on ophthalmic examination. A rapid increase in altitude while the air bubble is still present can cause a rise in eye pressure and irreversible vision loss.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of voretigene neparvovec in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
As a precautionary measure, it is preferable to avoid the use of voretigene neparvovec during pregnancy.
Voretigene neparvovec has not been studied in breast-feeding women. It is unknown whether voretigene neparvovec is excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from voretigene neparvovec therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
No clinical data on the effect of the medicinal product on fertility are available. Effects on male and female fertility have not been evaluated in animal studies.
Voretigene neparvovec has minor influence on the ability to drive and use machines. Patients may experience temporary visual disturbances after receiving subretinal injection of voretigene neparvovec. Patients should not drive or use heavy machines until visual function has recovered sufficiently, as advised by their ophthalmologist.
There were three non-serious adverse reactions of retinal deposits in three of 41 (7%) subjects that were considered to be related to voretigene neparvovec. All three of these events were a transient appearance of asymptomatic subretinal precipitates inferior to the retinal injection site, 1-6 days after injection and resolved without sequelae.
Serious adverse reactions related to the administration procedure were reported in three subjects during the clinical programme. One of 41 (2%) subjects reported a serious event of intraocular pressure increased (secondary to administration of depo-steroid) that was associated with treatment for endophthalmitis related to the administration procedure and resulted in optic atrophy, and one of 41 (2%) subjects reported a serious event of retinal disorder (loss of foveal function) that was assessed as related to the administration procedure. One of 41 (2%) subjects reported a serious event of retinal detachment that was assessed as related to the administration procedure.
The most common adverse reactions (incidence ≥5%) related to the administration procedure were conjunctival hyperaemia, cataract, increased intraocular pressure, retinal tear, dellen, macular hole, subretinal deposits, eye inflammation, eye irritation, eye pain and maculopathy (wrinkling on the surface of the macula).
The adverse reactions are listed by system organ class and frequency using the following convention: very common (≥1/10), common ≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Adverse reactions related to voretigene neparvovec:
Common: Retinal deposits
Adverse reactions related to administration procedure:
Common: Anxiety
Common: Headache, dizziness
Very common: Conjunctival hyperaemia, cataract
Common: Retinal tear, dellen, macular hole, eye inflammation, eye irritation, eye pain, maculopathy, choroidal haemorrhage, conjunctival cyst, eye disorder, eye swelling, foreign body sensation in eyes, macular degeneration, endophthalmitis, retinal detachment, retinal disorder, retinal haemorrhage
Common: Nausea, vomiting, abdominal pain upper, lip pain
Common: Rash, swelling face
Very common: Intraocular pressure increased
Common: Electrocardiogram T wave inversion
Common: Endotracheal intubation complication, wound dehiscence
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