GNH USA

USA — NDC

Luxturna 5000000000000 Vg

GNH USA supplies Luxturna (Voretigene Neparvovec), a gene therapy for RPE65-mediated inherited retinal dystrophy. Request a quote for global supply.

Voretigene Neparvovec
LUXTURNA
SOLUTION
5000000000000 VG

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1
Pack/s

What is Voretigene Neparvovec?

Voretigene neparvovec, the active ingredient in Luxturna 5000000000000 Vg, is a gene therapy presented as a 5,000,000,000,000 vg solution for subretinal use. It is indicated for the treatment of vision loss due to inherited retinal dystrophy caused by mutations in the RPE65 gene in adults and children. GNH USA supplies Luxturna 5000000000000 Vg as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals and clinics worldwide.

Luxturna is a groundbreaking gene therapy designed to address genetic disorders affecting vision. It is specifically formulated to deliver a functional copy of the RPE65 gene to retinal cells, thereby restoring vision in patients with specific genetic mutations.

What is Voretigene Neparvovec used for?

Luxturna is used in the treatment of inherited retinal dystrophy caused by mutations in the RPE65 gene. This condition leads to progressive vision loss and, in many cases, blindness. The therapy is designed to deliver a functional copy of the RPE65 gene to retinal cells, thereby restoring vision.

- RPE65-mediated inherited retinal dystrophy: Restores vision in patients with this genetic condition. - Biallelic RPE65 mutation-associated retinal dystrophy: Improves visual function and potentially slows further vision loss. - Leber congenital amaurosis type 2: Enhances visual cycle and improves visual acuity.

What are the side effects of Voretigene Neparvovec?

Luxturna may cause several side effects, ranging from common to serious. It is important to be aware of these potential effects and to consult with a healthcare provider if any adverse reactions occur.

Common Side Effects: - Redness of the eye - Eye swelling or pain - Clouding of the lens of the eye (cataract) - Increased pressure inside the eye - Eye infections - Retinal detachment - Bleeding in the retina - Permanent decline in the sharpness of your vision - Thinning of the retina or loss of function - Breaks or wrinkling on the surface of your retina - Deposits under your retina - Thinning of the clear layer in front of your eye - New or worsening cataract

What precautions apply to Voretigene Neparvovec?

Luxturna should be used with caution and under the supervision of a healthcare provider. Certain precautions and warnings should be observed to ensure safe and effective use.

- Avoid air travel or other travel to high elevations: Until advised by your doctor, as the air bubble inserted during treatment may expand and lead to eye damage. - Follow-up visits: Important to return for follow-up visits to identify and treat any side effects. - Eye surgery: Required before receiving Luxturna, which may lead to complications such as cataracts. - Subretinal injection: Should not be administered in the immediate vicinity of the fovea to maintain foveal integrity. - Store at ≤-65 ºC: Once thawed, the medicine should not be re-frozen and should be left at room temperature (below 25 °C).

What does Voretigene Neparvovec interact with?

Luxturna may interact with other medications or conditions, which can affect its efficacy or increase the risk of side effects. It is important to discuss all current medications and health conditions with a healthcare provider before starting Luxturna.

Major Interactions (Avoid): - None identified Moderate Interactions (Monitor Closely): - None identified

Frequently asked questions

What is Luxturna used for?+
Luxturna is used for the treatment of vision loss due to inherited retinal dystrophy caused by mutations in the RPE65 gene. It is specifically designed to deliver a functional copy of the RPE65 gene to retinal cells, thereby restoring vision in patients with this genetic condition.
How does Voretigene Neparvovec work?+
Voretigene neparvovec works by delivering a functional copy of the RPE65 gene to retinal pigment epithelial cells via an adeno-associated virus (AAV) vector. This gene therapy restores the visual cycle in patients with biallelic RPE65 mutations, enabling the production of proteins necessary for vision.
What is the usual dose of Luxturna?+
The dose of Luxturna is determined by a healthcare provider based on the patient's specific condition and needs. It is administered as a subretinal injection after vitrectomy in each eye. The exact dosage and administration schedule should be discussed with a healthcare professional.
Is Luxturna safe during pregnancy or breastfeeding?+
The safety of Luxturna during pregnancy or breastfeeding has not been established. It is important to consult with a healthcare provider to discuss the potential risks and benefits before using Luxturna in these situations.
How do I order Luxturna from GNH USA?+
To order Luxturna from GNH USA, submit an enquiry on the product page at gnh-usa.com with the required quantity. GNH USA supplies hospitals, pharmacies, and procurement teams across international markets and will ask the buyer to confirm trade or institutional credentials. The team will reply with pricing, availability, shipping, and the import paperwork.
How does Luxturna compare to other treatments for inherited retinal dystrophy?+
Luxturna is a pioneering gene therapy that offers a unique approach to treating inherited retinal dystrophy by directly addressing the genetic mutation. Unlike other treatments that may only manage symptoms, Luxturna aims to restore vision by delivering a functional copy of the RPE65 gene to retinal cells.
How should Luxturna be stored and handled?+
Luxturna should be stored and transported frozen at ≤-65 ºC. Once thawed, the medicine should not be re-frozen and should be left at room temperature (below 25 °C). It is important to follow the storage instructions provided by the healthcare professional to ensure the efficacy and safety of the medication.
How is Luxturna administered?+
Luxturna is administered as a subretinal injection after vitrectomy in each eye. The procedure is performed by a specialist in ophthalmology. The injection is given directly under the retina, the thin light-sensing layer at the back of the eye. The injections will happen one eye at a time, on two different dates separated by at least six days.
What are the most serious risks to watch for with Luxturna?+
The most serious risks associated with Luxturna include retinal detachment, bleeding in the retina, and permanent decline in the sharpness of vision. Patients should be monitored for any signs of these complications and should seek immediate medical attention if they experience any adverse effects.
Who should not use Luxturna?+
Luxturna is not suitable for everyone. Patients who do not have mutations in the RPE65 gene or who do not have sufficient viable retinal cells may not benefit from this treatment. It is important to undergo genetic testing to confirm eligibility for Luxturna. Additionally, patients with certain eye conditions or allergies to any of the components of Luxturna should avoid using this medication.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Voretigene Neparvovec
Brand
LUXTURNA
Strength
5000000000000 VG
Form
SOLUTION
Route
SUBRETINAL
Manufacturer
NOVARTIS PHARMACEUTICALS CANADA INC
Origin
CANADA

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