5 x 10 12 vector genomes/ml concentrate and solvent for injection, solution
Vortigern neparvovek
What Luxturna is and what it is used for
Luxturna is a gene therapy preparation with the active substance foreign neparvovek.
Luxturna is used to treat adults and children with vision loss due to inherited degradation of the retina due to mutations in the RPE65 gene. These mutations prevent the body from producing a protein needed for vision, leading to vision loss and ultimately to blindness.
The active substance in Luxturna is called Vortigern neparvovek and is a modified virus that contains a working copy of the RPE65 gene. After injection, the modified virus transmits the gene to the cells of the retina, the layer of tissue in the fundus that detects light. This allows the retina to produce the proteins needed for vision. The virus used to transmit the gene does not cause disease in humans.
You can only receive Luxturna if genetic testing shows that your vision loss is due to a mutation in the RPE65 gene.
What you need to know before you get the Luxury Tour
You do not get the Luxury Tour
- if you are allergic to voretigen neparvovek or any of the other ingredients of this medicine (listed in section 6).
- if you have an eye infection .
- if you have an eye inflammation.
If any of the above applies to you or if you are not sure about any of the above, talk to your doctor before taking Luxturna.
Warnings and cautions
Before you receive treatment with Luxturna:
- Tell your doctor if you have signs of an eye infection or eye inflammation, e.g. if you have red eyes or experience photosensitivity, eye swelling or eye pain.
- Tell your doctor if you have any active infection . Your doctor may postpone your treatment until the infection has disappeared, as this medicine may make it harder for your body to counteract an infection . See also section 3.
After treatment with Luxturna:
- Seek medical attention immediately if one or both eyes become red, begin to ache, become sensitive to light, if you see flashes or spots and dots (fly vision ) in the field of vision or if you notice deterioration of any shape or blurred vision.
- Avoid air travel and other travel to high altitudes until your doctor advises otherwise. During treatment with this medicine, the doctor inserts an air bubble into the eye which is slowly absorbed by the body. Before the bubble is completely absorbed, air travel or other travel to high altitudes can cause the bubble to become larger and cause eye damage, even loss of vision. Talk to your doctor before traveling.
- You should avoid swimming due to the increased risk of eye infection . Talk to a doctor before swimming after treatment with Luxturna.
- You should avoid strenuous physical activity due to the increased risk of eye damage. Talk to a doctor before starting strenuous physical activity after receiving Luxturna.
- Some pateinter get cataract ( cataract ). Cataracts mean that the lens inside the eye gets cloudy which can make it harder to see clearly. The appearance of cataracts or aggravated cataracts is a well-known complication of the eye surgery required before receiving Luxturna. There is also a risk of cataracts if the lens inside the eye is damaged by the needle used to inject the medicine into the back of the eye.
- You may have transient visual disturbances, e.g. photosensitivity and blurred vision. Tell your doctor if you experience visual disturbances. Your doctor can help reduce the discomfort that these transient disorders cause.
- There may be traces of the medicine in your tear fluid. You and your healthcare provider should therefore use bandages and waste materials that contain tear fluid and nasal secretions in closed bags before disposing of the waste. Follow these safety precautions for 14 days.
- You and your healthcare provider should wear gloves when changing dressings and when disposing of dressings and other waste materials, especially if you or your healthcare provider are pregnant, breastfeeding or have a weakened immune system. Follow these safety precautions for 14 days after treatment.
- You will not be able to donate blood, organs, tissues or cells for transplantation after treatment with Luxturna.
Children and young people
Luxury tours have not been studied for the treatment of children under 4 years.
Other medicines and Luxturna
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before taking Luxturna.
The effect of this drug on pregnancy and the unborn child is unknown. As a precautionary measure, do not take Luxturna if you are pregnant.
Luxury tours have not been studied in breastfeeding women. It is not known whether Luxturna passes into breast milk. Ask your doctor if you should stop breastfeeding after receiving Luxturna.
There are no data on the effect of Luxturna on male or female fertility.
Driving and using machines
You may experience transient visual disturbances after receiving Luxturna. Do not drive or use heavy machinery until your vision has recovered. Talk to your doctor before returning to these activities.
The luxury tour contains sodium
Luxturna contains less than 1 mmol (23 mg) sodium per dose, ie it is essentially ‘sodium-free’.
How to be given the Luxury Tower
The luxury tour will be given to you in an operating room by a surgeon with experience in eye surgery.
The luxury tour is given under anesthesia. The doctor will tell you about the anesthesia and how it is given.
Your doctor will remove the clear gel in your eye through eye surgery and then inject Luxturna directly under your retina (the thin light-sensing tissue layer at the base of the eye). This will be repeated in your other eye at least 6 days apart. After each procedure, you must remain for observation for a few hours. During this time, the staff monitors your recovery and monitors if any side effects have occurred due to the operation or anesthesia.
Before starting treatment with Luxturna, your doctor may prescribe a medicine that suppresses your immune system (the body’s natural defenses), so that it does not try to repel Luxturna when it is given. You must take this medicine according to the instructions given to you. Do not stop taking the medicine without talking to your doctor before.
If you use too much Luxturna
Because it is a doctor who is giving you this medicine, it is unlikely that you will get too much of it. If this happens, your doctor will treat the symptoms as needed. Tell your doctor or nurse if you have any vision problems.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur in users of Luxturna:
Common (may affect up to 1 in 10 people)
- Precipitation is under the retina
The following side effects may occur as a result of the injection procedure:
Very common (may affect more than 1 in 10 people)
- Red eye
- Cataracts ( cataracts , lens clouding)
- Increased eye pressure
Common (may affect up to 1 in 10 people)
- Retinal rupture (damaged retina )
- Eye pain
- Eye swelling
- Retinal detachment
- Nausea, vomiting, abdominal pain (stomach), lip pain
- Altered electrical activity in the heart
- Headache, dizziness
- Skin rash, facial swelling
- Anxiety
- Problems that can occur when placing breathing tubes in the airways ( intubation )
- Cracked surgical wound
No known frequency (can not be calculated from the available data)
- Clouding in the jelly-like mass in the eye ( vitreous one)
- Disappearance of the retina (and choroid)
Bleeding, swelling and an increased risk of infection may occur due to damage to the eye tissues. The vision is impaired during the days after the operation and usually passes by itself. Tell your doctor if your vision does not return.
How to store Luxturna
The luxury tours are stored by the medical staff in the ward where you are treated.
The concentrate and liquid must be stored and transported in a frozen state at ≤ ‑65 ºC. Once thawed, the product must not be re-frozen but must be left at room temperature (below 25 ° C).
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Contents of the pack and other information
Content declaration
- The active substance is voretigen neparvovek. Each milliliter of concentrate contains 5 x 10 12 vector genomes (vg). The concentrate (0.5 mL extractable volume in a vial of 2 ml single dose) should be diluted 1:10 before administration .
- Each dose of diluted solution contains 1.5 x 10 11 vector genomes of voretigen neparvovek in an injectable volume of 0.3 ml.
- The other ingredients in the concentrate are sodium chloride (see last part of section 2), sodium dihydrogen phosphate monohydrate (for pH adjustment ), disodium hydrogen phosphate dihydrate (for pH adjustment ), poloxamer 188 and water for injections.
- The other ingredients in the liquid are sodium chloride (see last part of section 2), sodium dihydrogen phosphate monohydrate (for pH adjustment ), disodium hydrogen phosphate dihydrate (for pH adjustment ), poloxamer 188 and water for injections.
What the medicine looks like and contents of the pack
Luxturna is a clear, colorless concentrate for solution for injection under the retina; provided in a clear plastic vial. The diluent is a clear, colorless liquid that is supplied in a clear plastic vial.
Each foil protective bag contains one carton of 1 vial containing concentrate and 2 vials containing liquid.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaSIA “Novartis Baltics” Lithuanian branchesTel: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
| Czech RepublicNovartis sroTel: +420 225 775 111 | HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872 |
| GermanyNovartis Pharma GmbHTel: +49 911 273 0 | The NetherlandsNovartis Pharma BVTel: +31 26 37 82 111 |
| EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 | NorwayNovartis Norge ASTel: +47 23 05 20 00 |
| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600 |
| CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 | SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439 |
| ItalyNovartis Farma SpATel: +39 02 96 54 1 | Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200 |
| .ΠροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 | SwedenNovartis Sverige ABTel: +46 8 732 32 00 |
| LatviaSIA “Novartis Baltics”Tel: +371 67 887 070 |