Luxturna TM
Listen to the Pronunciation:
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: inert substance, voretigene neparvovec
Pack: Luxturna (1 x 0.5 mL vial, 2 x 1.7 mL inert diluent vials), 1 pack
Brand name
(ARTG)
: LUXTURNA voretigene neparvovec 5 x 10(12) (vg) per mL concentrate solution for injection vial with diluent ampouleConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Luxturna is indicated for the treatment of patients with inherited retinal dystrophy caused by pathological biallelic RPE65 mutations and who have sufficient viable retinal cells as determined by the treating physician.,Pathological mutations of RPE65 should be confirmed by a National Association of Testing Authorities (NATA) or International Laboratory Accreditation Cooperation (ILAC) accredited laboratory.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Drug delivery system, ocular
- Intraocular
- Concentrate in 2 ml cyclic olefin polymer vial, a chlorobutyl rubber stopper sealed in place with an aluminium flip-off seal .also includes diluents. Both the concentrate and the diluent are clear, colourless preservative-free liquids.
Component :
- Injection, concentrated
- Intravitreal-Within The Vitreous Cavity Of The Eye
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Shelf lifetime is 36 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is
- 1 vial of concentrate; 2 vials of diluent pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient voretigene neparvovec
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
