Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥ 5%) were conjunctival hyperemia, cataract, increased intraocular pressure, retinal tear, dellen (thinning of the corneal stroma), macular hole, subretinal deposits, eye inflammation, eye irritation, eye pain, and maculopathy (wrinkling on the surface of the macula).
The most common adverse reactions (incidence ≥ 5%) in the clinical trials were conjunctival hyperemia, cataract, increased intraocular pressure, retinal tear, dellen (thinning of the corneal stroma), macular hole, subretinal deposits, eye inflammation, eye irritation, eye pain, and maculopathy (wrinkling on the surface of the macula).
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Spark Therapeutics, Inc.
at 1-855-SPARKTX, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of other products and may not reflect the rates observed in practice.
The safety data described in this section reflect exposure to LUXTURNA in two clinical trials consisting of 41 subjects (81 eyes) with confirmed biallelic RPE65 mutation-associated retinal dystrophy.
Forty of the 41 subjects received sequential subretinal injections of LUXTURNA to each eye.
One subject received LUXTURNA in only one eye.
Seventy-two of the 81 eyes were exposed to the recommended dose of LUXTURNA at 1.5 x 10 11 vg;
9 eyes were exposed to lower doses of LUXTURNA.
5 WARNINGS AND PRECAUTIONS Endophthalmitis: Use proper aseptic injection technique and monitor for signs and symptoms of infection.
( 5.1 ) Permanent decline in visual acuity: Monitor for visual disturbances.
( 5.2 ) Retinal abnormalities: Monitor for macular abnormalities, retinal tears or breaks and chorioretinal atrophy.
Do not inject in the immediate vicinity of the fovea.
( 5.3 ) Increased intraocular pressure: Monitor and manage intraocular pressure elevations.
Like all medications, Luxturna can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: