LUXTURNA(voretigene neparvovec-rzyl)intraocular suspension forsubretinal injection(十一)
rovider if they exeprience any change in vision.
• Retinal abnormalities Treatment with LUXTURNA may cause some defects in the retina such as a small tear or a hole in the areaor vicinity of the injection. Treatment may cause thinning of the central retina or bleeding in the retina.
Advise patients to follow up with their healthcare provider on a regular basis and report any symptoms suchas decreased vision, blurred vision, flashes of light, or floaters in their vision without delay.
• Increased intraocular pressure
Treatment with LUXTURNA may cause transient or persistent increase in intraocular pressure. If
untreated, such increases in intraocular pressure may cause blindness. Advise patients to follow-up with
their healthcare provider to detect and treat any increase in intraocular pressure.
• Expansion of intraocular air bubbles
Advise patients to avoid air travel, travel to high elevations or scuba diving until the air bubble formedfollowing administration of LUXTURNA has completely dissipated from the eye. A change in altitudewhile the air bubble is still present may cause irreversible damage.
• Cataract
Advise patients that following treatment with LUXTURNA, they may develop a new cataract, or anyexisting cataract may get worse.
• Shedding of LUXTURNA
Transient and low level shedding of LUXTURNA may occur in patient tears. Advise patients and/or theircaregivers on proper handling of waste material generated from dressing, tears and nasal secretion, whicmay include storage of waste material in sealed bags prior to disposal.
These handling precautions shouldbe followed for up to 7 days following LUXTURNA administration.
Manufactured by:
Spark Therapeutics, Inc.
3737 Market Street
Philadelphia, PA 19104
US License #2056
LUXTURNA is a trademark of Spark Therapeutics, Inc.
© 2017 Spark Therapeutics, Inc
http://sparktx.com/LUXTURNA_US_Prescribing_Information.pdf
http://sparktx.com/LUXTURNA_US_Prescribing_Information.pdf |
