Generic Name and Formulations:
Voretigene neparvovec-rzyl 5x1012 vector genomes (vg); per mL; susp for subretinal inj after dilution; preservative-free.
Spark Therapeutics, Inc.
Indications for LUXTURNA:
Treatment of biallelic RPE65 mutation-associated retinal dystrophy.
Adults and Children:
Must have viable retinal cells as determined by physician. Give as subretinal inj. <12mos: not recommended. ≥12mos: 1.5x1011 vg (total 0.3mL) for each eye; separate injs to each eye by ≥6 days. Start oral corticosteroid regimen 3 days prior to Luxturna inj in first eye: give equivalent to prednisone 1mg/kg/day (max 40mg/day) for 7 days and taper dose for the next 10 days; apply same regimen for second eye.
Use aseptic technique. Do not inj in immediate vinicity of fovea. Monitor for infection, inflammation, visual disturbances, retinal abnormalities, intraocular pressure; manage appropriately. Avoid changes in altitude (eg, air travel, high elevations, scuba diving) until intraocular air bubble has completely dissipated. Elderly: not established. Pregnancy. Nursing mothers.
Adeno-associated virus vector-based gene therapy.
Conjunctival hyperemia, cataract, increased intraocular pressure, retinal tear, dellen, macular hole, subretinal deposits, eye inflammation/irritation/pain, maculopathy; endophthalmitis.
Single-dose vial (0.5mL)—1 (w. diluent)