Luxturna (Voretigene neparvovec-rzyl)
- Drug Name: Luxturna
- Generic Name: Voretigene neparvovec-rzyl
- Dosage Forms and Strengths: Luxturna is a suspension for subretinal injection supplied in a 0.5 mL single-dose 2 mL vial. The concentration is 5×10^12 vg/mL and requires 1:10 dilution prior to administration in one eye only. The provided diluent comes in two 2 mL single-use vials.
- Manufactured by: Spark Therapeutics, Inc.
Medical uses
Warning & Precautions
Documentation & Availability
Sourcing & Delivery
FAQ
Medical uses
LUXTURNA is a gene therapy that uses an adeno-associated virus vector. It’s designed for patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy, provided they have viable retinal cells, as determined by their treating physician(s).
Dosage and Administration:
- The suggested dose of LUXTURNA for each eye is 1.5 x 1011 vector genomes (vg) delivered via subretinal injection in a volume of 0.3 mL.
- Subretinally administer LUXTURNA to each eye on different days at least 6 days apart.
- Administer systemic oral corticosteroids equivalent to prednisone at 1 mg/kg/day (maximum 40 mg/day) for 7 days, beginning 3 days before administering LUXTURNA to each eye, followed by a decreasing dose over the next 10 days.
Warning & Precautions
- endophthalmitis: Proper sterile technique must be used during injection to prevent infection. Monitor for signs of infection
- .Permanent vision loss: Watch for any changes or disturbances in vision.
- Abnormalities in the retina: Screen for any abnormalities, tears, or deterioration in the retina. Do not inject near the center of the retina.
- Increased eye pressure: Monitor and manage any increases in eye pressure.
- Expanding air bubbles: Avoid air travel or scuba diving until any air bubbles in the eye have been absorbed.
- Cataracts: The injection may cause cataracts to develop or progress at a faster rate. The lens of the eye should be monitored.
Documentation & Availability
If you are considering the import of Luxturna (Voretigene neparvovec-rzyl) to India, please be aware that Luxturna can be imported by patients or government hospitals solely in the name of the patients. The following documentation is essential for the successful import of this medication:
Required Documentation for Import:
- A valid prescription from a qualified medical practitioner.
- Diagnostic reports of the patient.
- Government-issued identification proof for the patient, as recognized by the Government of India.
Order Confirmation Process:
The order for Luxturna (Voretigene neparvovec-rzyl) will be confirmed upon the receipt of the following documents:
- A valid prescription from a qualified doctor.
- An import permit, if applicable.
Availability of Luxturna in India:
Luxturna (Voretigene neparvovec-rzyl) is classified as a prescription pharmaceutical drug. Consequently, it legally requires a medical prescription to be dispensed. Indian Pharma Network (IPN) specializes in facilitating the import of cancer medicines through named patient supply (NPS), ensuring transparency and authenticity by sourcing from reputable suppliers in the USA, Canada, Europe, and Australia.
Luxturna (Voretigene neparvovec-rzyl) can be made accessible to patients, doctors, and hospitals in various cities across India, including but not limited to Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Srinagar, Jammu, Jaipur, Chandigarh, Ludhiana, Noida, Gurgaon, Lucknow, and Pune. To confirm an order, a valid prescription from a doctor and an import permit will be required.
IPN (Indian Pharma Network) is dedicated to facilitating the supply of Luxturna (prescription medicines) to locations both within India and worldwide, while adhering to relevant legal requirements.
For inquiries regarding the price of Luxturna in India and to initiate the ordering process, please reach out to us through the following contact details:
Our commitment lies in assuring quality and timely delivery to meet the healthcare needs of patients and medical professionals across the globe.
Sourcing & Delivery
Indian Pharma Network is proficient in sourcing Luxturna (Voretigene neparvovec-rzyl) from around the world and ensuring efficient delivery to patients. We provide worldwide access to the best available treatments and expedite prescription dispensing and delivery, with all prescriptions being dispensed and scrutinized by registered pharmacists before dispatching them to the patient’s address, exclusively from New Delhi, India.
FAQ
Does the FDA approve Luxturna?
Luxturna is the first FDA-authorized gene therapy for a genetic condition, the first and only pharmacologic treatment for an inherited retinal disease (IRD), and the first AAV vector gene therapy to be approved in the United States.
What is Luxturna, and what does it treat?
Luxturna is a gene therapy designed to treat a rare genetic condition called biallelic RPE65 mutation-associated retinal dystrophy. This condition affects the retinal pigment epithelium (RPE) cells in the eye, leading to vision loss and potentially blindness.
How is Luxturna administered?
Luxturna is a one-time treatment delivered via injection into the eye. The procedure requires prior surgery called a vitrectomy to clear the vitreous gel in the eye. The therapy is then injected under the retina in a single-use vial, requiring administration in each affected eye.
Who is eligible for Luxturna?
This therapy is only approved for patients with confirmed biallelic RPE65 mutations and viable RPE cells, as determined by a healthcare professional. Confirmation of the genetic mutation and cell viability are crucial for treatment success and safety.
What are the potential side effects of Luxturna?
As with any medication, Luxturna comes with potential side effects. Some common ones include inflammation in the eye, eye pain, retinal detachment, and cataract formation. It is important to discuss all potential risks and benefits with your doctor before deciding on this treatment.
Is Luxturna a cure for blindness?
While Luxturna is a breakthrough in treating RPE65-related vision loss, it is not a complete cure for blindness. It can significantly improve vision for patients with this specific condition, but the extent and effectiveness vary depending on individual cases. Ongoing research is exploring the potential of gene therapy for other types of blindness as well.
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