LUXTURNA®: A gene therapy for vision loss* for your patients with an RPE65-IRD
The first and only gene therapy indicated in vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutation1,2†
Important Safety Information
Clinical use:
Patients will receive a single dose of LUXTURNA® in each eye, no fewer than 6 days apart.
LUXTURNA® is administered as a subretinal injection after vitrectomy.
Safety and efficacy in pediatric patients (<4 years of age) and geriatric patients (≥65 years of age) have not been established.
Contraindications:
Hypersensitivity to LUXTURNA® or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container
Ocular or periocular infection
Active intraocular inflammation
Relevant warnings and precautions:
LUXTURNA® should be administered by a retinal surgeon experienced in performing subretinal surgery
Endophthalmitis following any intraocular surgical procedure or injection
Permanent decline in visual acuity
Retinal abnormalities during or following subretinal injection of LUXTURNA®: macular holes, foveal thinning, loss of foveal function, foveal dehiscence, and retinal hemorrhage; retinal abnormalities during or following vitrectomy: retinal tears, epiretinal membrane, or retinal detachment
Increased intraocular pressure
Expansion of intraocular air bubbles
Increased incidence of cataract development and/or progression
Avoid use of LUXTURNA® during pregnancy
Transient and low-level vector shedding may occur in patient tears
Patients treated with LUXTURNA® should not donate blood, organs, tissues and cells for transplantation
For more information:
Please consult the Product Monograph at www.novartis.ca/luxturna for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-363-8883 or by email at [email protected].
Mechanism of action
LUXTURNA® is a gene therapy designed to deliver a normal copy of the RPE65 gene to the cells of the retina1‡
Learn more about the LUXTURNA® mechanism of action‡
VIDEO
Genetic testing is appropriate for most patients with presumed inherited retinal dystrophy (IRD)3
IRDs comprise a wide range of genetically and phenotypically heterogeneous diseases that lead to progressive visual loss.3
Consider including genetic testing as part of the baseline assessment of your patients3
Download helpful patient materials
Take a closer look at LUXTURNA®’s efficacy data and safety profile
RPE65-IRD=RPE65 mutation-associated inherited retinal dystrophy
*Patients will receive a single dose of 1.5 x 1011 vg of LUXTURNA® in each eye, no fewer than 6 days apart.1
† Comparative clinical significance is unknown.
‡ Clinical significance has not been established.
References
LUXTURNA® product monograph. Novartis Pharmaceuticals Canada Inc. April 20, 2022.
Data on file. Attestation letter. Novartis. February 5, 2024.
American Academy of Ophthalmology. Recommendations on Clinical Assessment of Patients with Inherited Retinal Degenerations – 2016. https://www.aao.org/clinical-statement/recommendations-on-clinical-asses.... Accessed on April 14, 2021
© 2024 Novartis Pharmaceuticals Canada Inc. All rights reserved.
® LUXTURNA is a registered trademark of Spark Therapeutics Inc., used under license by Novartis Pharmaceuticals Canada Inc.
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month/2024 - FA-11218953
