Important safety information FOR LUXTURNA
The following serious side effects may occur during or after the administration of LUXTURNA:
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Eye infections, including a serious infection inside of the eye called endophthalmitis, that may lead to blindness.
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Permanent decline in visual acuity, or the sharpness of central vision.
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Changes in the retina (the thin layer of tissue in the back of the eye) including:
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development of a hole, thinning, or loss of function of the retina, separation of the layers in the center of the retina, or bleeding in the retina.
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breaks in or wrinkling on the surface of the retina or detachment of the retina.
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Increased pressure inside of the eye. You should follow-up with your healthcare professional as instructed to detect and treat any increased pressure in the eye as this may cause blindness.
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Expansion of the air bubble formed in the eye after administration of LUXTURNA. You should avoid air travel, travel to high elevations, or scuba diving until your healthcare professional has told you that the air bubble formed in the eye following administration of LUXTURNA has disappeared. Engaging in these activities while the air bubble is present can cause permanent vision loss.
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Formation or worsening of cataract (clouding of the lens inside of the eye).
Tell your healthcare professional right away if you have any of the following symptoms of these serious side effects:
The following are the most common side effects that may occur with LUXTURNA:
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Redness of the eye
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Cataract (clouding of the lens inside of the eye)
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Increased pressure inside of the eye
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Breaks in the retina
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Dellen (thinning of the clear layer in the front of the eye)
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Development of a hole in the center of the retina
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Subretinal deposits (deposits under the retina)
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Eye swelling, irritation or pain
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Wrinkling on the surface of the center of the retina
Treatment with LUXTURNA is not recommended for patients younger than 12 months of age because the retina is still growing, which may affect how LUXTURNA works.
Because small quantities of LUXTURNA may be in your tears for a short period of time, for the first 7 days after administration of LUXTURNA, place any waste material from dressings, tears and nasal secretions in sealed bags prior to disposal.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call
1-800-FDA-10881-800-FDA-1088. You may also report side effects to Spark Therapeutics at
1-855-SPARKTX 1-855-SPARKTX (1-855-772-7589)(1-855-772-7589).
This information does not take the place of talking to your healthcare professional about your medical condition or treatment. If you have questions about LUXTURNA after reading this information, ask your healthcare professional.
INDICATION
LUXTURNA (voretigene neparvovec-rzyl) is a prescription gene therapy product used for the treatment of patients with inherited retinal disease due to mutations in both copies of the RPE65 gene, which can only be confirmed through genetic testing. You must also have enough remaining cells in your retina (the thin layer of tissue in the back of your eyes) as determined by your healthcare professional.
Please see US Full Prescribing Information for LUXTURNA.
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