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Luxturna Generic Name & Formulations
Legal Class
Rx
General Description
Voretigene neparvovec-rzyl 5x10^12 vector genomes (vg); per mL; susp for subretinal inj after dilution; preservative-free.
Pharmacological Class
Adeno-associated virus vector-based gene therapy.
How Supplied
Single-dose vial (0.5mL)—1 (w. diluent)
Manufacturer
Generic Availability
NO
Mechanism of Action
Luxturna is designed to deliver a normal copy of the gene encoding the human retinoid isomerohydrolase RPE65 (RPE65) to cells of the retina in persons with reduced or absent levels of biologically active RPE65. The RPE65 is produced in the retinal pigment epithelial (RPE) cells and converts all-trans-retinol to 11-cis-retinol, which subsequently forms the chromophore, 11-cis-retinal, during the visual (retinoid) cycle.
Luxturna Indications
Indications
Treatment of biallelic RPE65 mutation-associated retinal dystrophy.
Luxturna Dosage and Administration
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.
Luxturna Contraindications
Not Applicable
Luxturna Boxed Warnings
Not Applicable
Luxturna Warnings/Precautions
Warnings/Precautions
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.
Luxturna Pharmacokinetics
See Literature
Luxturna Interactions
Not Applicable
Luxturna Adverse Reactions
Adverse Reactions
Conjunctival hyperemia, cataract, increased intraocular pressure, retinal tear, dellen, macular hole, subretinal deposits, eye inflammation/irritation/pain, maculopathy; endophthalmitis.
Luxturna Clinical Trials
See Literature
Luxturna Note
Not Applicable
Luxturna Patient Counseling
See Literature
