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Luxturna (Voretigene Neparvovec-Rzyl)

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  • Product Details

    Description

    Luxturna (voretigene neparvovec-rzyl) is a gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy, a rare inherited condition that leads to progressive vision loss and eventual blindness. It is the first FDA-approved gene therapy for an inherited retinal disease. Luxturna delivers a functional copy of the RPE65 gene directly to retinal cells through a subretinal injection, enabling production of the RPE65 protein, which is essential for the visual cycle and photoreceptor function.

    Fact Table

    Formula

    Gene therapy (AAV2 vector encoding RPE65 gene)

    License

    US FDA (2017), EMA

    Bioavailability

    Localized (subretinal delivery)

    Legal status

    Rx-only

    Chemical Name

    Voretigene neparvovec-rzyl

    Elimination half-life

    Not applicable (gene expression is sustained)

    Dosage (Strength)

    1.5 × 10¹¹ vector genomes (vg) per 0.3 mL (one-time per eye)

    Pregnancy

    Use only if clearly needed; insufficient data

    Brands

    Luxturna

    Protein binding

    Not applicable

    PubChem CID

    Not assigned (biologic/gene therapy)

    MedlinePlus

    a619040

    ChEBI

    Not listed

    ATC code

    S01XA27

    DrugBank

    DB13919

    KEGG

    D11025

    Routes of administration

    Subretinal injection (surgical procedure)

    Directions

    Luxturna is administered as a one-time subretinal injection in each eye, with the second eye treated no sooner than 6 days after the first. Each eye receives 1.5 × 10¹¹ vector genomes (vg) in a total volume of 0.3 mL.

    • Patients must receive systemic corticosteroids (e.g., prednisone 1 mg/kg/day) starting 3 days before the first injection, continuing for a total of 7 days, and then tapered over the next 10 days.
    • Administration must be performed by a retinal surgeon experienced in subretinal injections under controlled surgical conditions.

    Ingredients

    Each vial of Luxturna contains:

    • Voretigene neparvovec-rzyl 5 × 10¹² vector genomes/mL (in 0.5 mL)
    • Sodium chloride
    • Sodium phosphate (monobasic and dibasic)
    • Magnesium chloride
    • Potassium chloride
    • Calcium chloride
    • Glucose
    • Poloxamer 188
    • Water for injection

    The product is preservative-free and supplied as a frozen suspension requiring thawing and dilution prior to administration.

    Contraindications

    Luxturna is contraindicated in patients with:

    • Active ocular or periocular infection
    • Active intraocular inflammation

    Cautions

    • Endophthalmitis, retinal tears, increased intraocular pressure, and macular abnormalities may occur after injection.
    • Use caution in patients with pre-existing retinal thinning or degeneration.
    • Immune responses to the AAV vector or transgene may occur; immunosuppressive therapy is required.
    • Bilateral simultaneous administration is not recommended due to potential complications.
    • Avoid air travel or high-altitude environments until intraocular gas used during surgery is fully absorbed to prevent increased intraocular pressure.

    Side Effects

    Common side effects of Luxturna include:

    • Ocular inflammation (e.g., anterior chamber or vitreous cells)
    • Increased intraocular pressure
    • Cataract
    • Conjunctival hyperemia
    • Eye pain
    • Macular hole or thinning
    • Retinal hemorrhage
    • Subretinal deposits

    Serious adverse effects may include:

    • Endophthalmitis
    • Retinal detachment or tear
    • Macular atrophy
    • Loss of visual acuity

    Patients should be monitored postoperatively for ocular complications and managed accordingly.

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 14595

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