LUXTURNA Concentrate and solvent for solution for injection Ref.[8763] Active ingredients: Voretigene neparvovec

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

Luxturna 5 x 1012 vector genomes/mL concentrate and solvent for solution for injection.

Pharmaceutical Form

Concentrate and solvent for solution for injection.

Following thaw from their frozen state, both the concentrate and the solvent are clear, colourless liquids with a pH of 7.3.

Qualitative and quantitative composition

Voretigene neparvovec is a gene transfer vector that employs an adeno-associated viral vector serotype 2 (AAV2) capsid as a delivery vehicle for the human retinal pigment epithelium 65 kDa protein (hRPE65) cDNA to the retina. Voretigene neparvovec is derived from wild-type AAV2 using recombinant DNA techniques.

Each mL of concentrate contains 5 × 1012 vector genomes (vg).

Each vial of Luxturna contains 0.5 extractable mL of concentrate (corresponding to 2.5 × 1012 vector genomes) which requires a 1:10 dilution prior to administration, see section 6.6.

After dilution of 0.3 mL of concentrate with 2.7 mL of solvent, each mL contains 5 × 1011 vector genomes. Each dose of 0.3 mL Luxturna contains 1.5 x 1011 vector genomes.

For the full list of excipients, see section 6.1.

Active Ingredient

Voretigene neparvovec results to transduction of retinal pigment epithelial cells with a cDNA encoding normal human RPE65 protein (gene augmentation therapy), providing the potential to restore the visual cycle in patients with vision loss due to inherited retinal dystrophy.
List of Excipients

Concentrate:

Sodium chloride
Sodium dihydrogen phosphate monohydrate (for pH adjustment)
Disodium hydrogen phosphate dihydrate (for pH adjustment)
Poloxamer 188
Water for injections

Solvent:

Sodium chloride
Sodium dihydrogen phosphate monohydrate (for pH adjustment)
Disodium hydrogen phosphate dihydrate (for pH adjustment)
Poloxamer 188
Water for injections

Pack sizes and marketing

Concentrate:

0.5 mL extractable volume of concentrate in 2 mL cyclic olefin polymer vial with a chlorobutyl rubber stopper sealed in place with an aluminium flip-off seal.

Solvent:

1.7 mL extractable volume of solvent in a 2 mL cyclic olefin polymer vial with a chlorobutyl rubber stopper sealed in place with an aluminium flip-off seal.

Each foil pouch includes a carton containing 1 vial of concentrate of 0.5 mL and 2 vials of solvent (each containing 1.7 mL).

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/18/1331/001

Date of first authorisation: 22 November 2018
Date of latest renewal: 24 July 2023

Drugs

Drug Countries
LUXTURNA Austria, Brazil, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈