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Voretigene neparvovec ophthalmic Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 20, 2020.

For the Consumer

Applies to voretigene neparvovec ophthalmic: intraocular suspension

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad infections or other eye problems can happen inside the eye. These could lead to loss of eyesight. Call your doctor right away if you have a change in eyesight, eye pain, or very bad eye irritation. Call your doctor right away if you see any new floaters or flashes of light.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Eye irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to voretigene neparvovec ophthalmic: intraocular suspension

General

The most commonly reported adverse reactions have included eye redness, cataract, increased intraocular pressure, and retinal tear.[Ref]

Ocular

Very common (10% or more): Any ocular adverse reaction (66%), conjunctival hyperemia (redness; 22%), cataract (20%), increased intraocular pressure (15%), retinal tear (10%)

Common (1% to 10%): Thinning of the corneal stroma (dellen), macular holes, subretinal deposits, eye inflammation, eye irritation, eye pain, maculopathy, foveal thinning and loss of foveal function, endophthalmitis, foveal dehiscence (separation of the retinal layers in the center of the macula) retinal hemorrhage

Ocular adverse reactions were reported in 66% (27/41) of subjects (46 out of 81 injected eyes; 57%). Adverse reactions may have been due to this drug, the subretinal injection procedure, the concomitant use of corticosteroids, or a combination of the all three.

References

1. Aziz MY, Hoffmann KJ, Ashton M "Inhibition of CYP3A by antimalarial piperaquine and its metabolites in human liver microsomes with IVIV extrapolation." J Pharm Sci (2018):

2. "Product Information. Luxturna (voretigene neparvovec ophthalmic)." Spark Therapeutics, Inc., Philadelphia, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.