{"id":17230,"date":"2022-01-06T07:44:23","date_gmt":"2022-01-06T07:44:23","guid":{"rendered":"https:\/\/zeepedia.com\/?p=17230"},"modified":"2022-01-06T10:32:50","modified_gmt":"2022-01-06T10:32:50","slug":"luxturna","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/luxturna\/","title":{"rendered":"Luxturna – Voretigen neparvovek uses, dose and side effects"},"content":{"rendered":"\n

5 x 10\u00a012<\/sup>\u00a0vector genomes\/ml\u00a0concentrate and solvent for\u00a0injection, solution
Vortigern neparvovek<\/p>\n\n\n\n

What Luxturna is and what it is used for<\/h2>\n\n\n\n

Luxturna is a gene therapy preparation with the active substance foreign neparvovek.<\/p>\n\n\n\n

Luxturna is used to treat adults and children with vision loss due to inherited degradation of the retina due to mutations in the RPE65<\/em> gene. These mutations prevent the body from producing a protein needed for vision, leading to vision loss and ultimately to blindness.<\/p>\n\n\n\n

The active substance in Luxturna is called Vortigern neparvovek and is a modified\u00a0virus\u00a0that contains a working copy of the\u00a0RPE65\u00a0gene.\u00a0After\u00a0injection, the modified\u00a0virus\u00a0transmits the\u00a0gene to the cells of the retina, the layer of tissue in the fundus that detects light.\u00a0This allows the retina to produce the\u00a0proteins\u00a0needed for vision.\u00a0The virus\u00a0used to transmit the gene does not cause disease in humans.<\/p>\n\n\n\n

You can only receive Luxturna if genetic testing shows that your vision loss is due to a mutation in the RPE65<\/em> gene.<\/p>\n\n\n\n

What you need to know before you get the Luxury Tour<\/h2>\n\n\n\n

You do not get the Luxury Tour<\/h2>\n\n\n\n
  • if you are allergic to voretigen neparvovek or any of the other ingredients of this medicine (listed in section 6).<\/li>
  • if you have an eye infection .<\/li>
  • if you have an eye inflammation.<\/li><\/ul>\n\n\n\n

    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.<\/p>\n\n\n\n

    Warnings and cautions<\/h2>\n\n\n\n

    Before you receive treatment with Luxturna:<\/p>\n\n\n\n

    • 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.<\/li>
    • 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.<\/li><\/ul>\n\n\n\n

      After treatment with Luxturna:<\/p>\n\n\n\n

      • 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.<\/li>
      • 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.<\/li>
      • You should avoid swimming due to the increased risk of eye infection . Talk to a doctor before swimming after treatment with Luxturna.<\/li>
      • 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.<\/li>
      • 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.<\/li>
      • 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.<\/li>
      • 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.<\/li>
      • 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.<\/li>
      • You will not be able to donate blood, organs, tissues or cells for transplantation after treatment with Luxturna.<\/li><\/ul>\n\n\n\n

        Children and young people<\/h2>\n\n\n\n

        Luxury tours have not been studied for the treatment of children under 4 years.<\/p>\n\n\n\n

        Other medicines and Luxturna<\/h2>\n\n\n\n

        Tell your doctor if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n

        Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n

        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.<\/p>\n\n\n\n

        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.<\/p>\n\n\n\n

        Luxury tours have not been studied in breastfeeding women.\u00a0It is not known whether Luxturna passes into breast milk.\u00a0Ask your doctor if you should stop breastfeeding after receiving Luxturna.<\/p>\n\n\n\n

        There are no data on the effect of Luxturna on male or female\u00a0fertility.<\/p>\n\n\n\n

        Driving and using machines<\/h2>\n\n\n\n

        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.<\/p>\n\n\n\n

        The luxury tour contains sodium<\/h2>\n\n\n\n

        Luxturna contains less than 1 mmol (23 mg)\u00a0sodium\u00a0per\u00a0dose, ie it is essentially ‘sodium-free’.<\/p>\n\n\n\n

        How to be given the Luxury Tower<\/h2>\n\n\n\n

        The luxury tour will be given to you in an operating room by a surgeon with experience in eye surgery.<\/p>\n\n\n\n

        The luxury tour is given under anesthesia. The doctor will tell you about the anesthesia and how it is given.<\/p>\n\n\n\n

        Your doctor will remove the clear\u00a0gel\u00a0in your eye through eye surgery and then inject Luxturna directly under your\u00a0retina\u00a0(the thin light-sensing tissue layer at the base of the eye).\u00a0This will be repeated in your other eye at least 6 days apart.\u00a0After each procedure, you must remain for observation for a few hours.\u00a0During this time, the staff monitors your recovery and monitors if any\u00a0side effects\u00a0have occurred due to the operation or anesthesia.<\/p>\n\n\n\n

        Before starting treatment with Luxturna, your doctor may\u00a0prescribe\u00a0a medicine that suppresses your immune system (the body’s natural defenses), so that it does not try to repel Luxturna when it is given.\u00a0You must take this medicine according to the instructions given to you.\u00a0Do not stop taking the medicine without talking to your doctor before.<\/p>\n\n\n\n

        If you use too much Luxturna  <\/h2>\n\n\n\n

        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.<\/p>\n\n\n\n

        If you have any further questions on the use of this product, ask your doctor or nurse.<\/p>\n\n\n\n

        Possible side effects<\/h2>\n\n\n\n

        Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n

        The following side effects may occur in users of Luxturna:<\/p>\n\n\n\n

        Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n

        • Precipitation is under the retina<\/li><\/ul>\n\n\n\n

          The following side effects may occur as a result of the injection procedure:<\/p>\n\n\n\n

          Very common (may affect more than 1 in 10 people)<\/strong><\/p>\n\n\n\n

          • Red eye<\/li>
          • Cataracts ( cataracts , lens clouding)<\/li>
          • Increased eye pressure<\/li><\/ul>\n\n\n\n

            Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n

            • Retinal rupture (damaged retina )<\/li>
            • Eye pain<\/li>
            • Eye swelling<\/li>
            • Retinal detachment<\/li>
            • Nausea, vomiting, abdominal pain (stomach), lip pain<\/li>
            • Altered electrical activity in the heart<\/li>
            • Headache, dizziness<\/li>
            • Skin rash, facial swelling<\/li>
            • Anxiety<\/li>
            • Problems that can occur when placing breathing tubes in the airways ( intubation )<\/li>
            • Cracked surgical wound<\/li><\/ul>\n\n\n\n

              No known frequency <\/strong>(can not be calculated from the available data)<\/strong><\/p>\n\n\n\n

              • Clouding in the jelly-like mass in the eye ( vitreous one)<\/li>
              • Disappearance of the retina (and choroid)<\/li><\/ul>\n\n\n\n

                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.<\/p>\n\n\n\n

                How to store Luxturna<\/h2>\n\n\n\n

                The luxury tours are stored by the medical staff in the ward where you are treated.<\/p>\n\n\n\n

                The concentrate and liquid must be stored and transported in a frozen state at \u2264 \u201165 \u00baC. Once thawed, the product must not be re-frozen but must be left at room temperature (below 25 \u00b0 C).<\/p>\n\n\n\n

                Do not use this medicine after the expiry date which is stated on the label and carton after EXP.<\/p>\n\n\n\n

                Contents of the pack and other information<\/h2>\n\n\n\n

                Content declaration<\/h2>\n\n\n\n
                • The active substance is voretigen neparvovek. Each milliliter of concentrate contains 5 x 10 12<\/sup> 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 .<\/li>
                • Each dose of diluted solution contains 1.5 x 10 11<\/sup> vector genomes of voretigen neparvovek in an injectable volume of 0.3 ml.<\/li>
                • 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.<\/li>
                • 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.<\/li><\/ul>\n\n\n\n

                  What the medicine looks like and contents of the pack<\/h2>\n\n\n\n

                  Luxturna is a clear, colorless concentrate for solution for\u00a0injection\u00a0under the retina;\u00a0provided in a clear\u00a0plastic\u00a0vial.\u00a0The diluent is a clear, colorless liquid that is supplied in a clear\u00a0plastic\u00a0vial.<\/p>\n\n\n\n

                  Each foil protective bag contains one carton of 1 vial containing concentrate and 2 vials containing liquid.<\/p>\n\n\n\n

                  Marketing Authorisation Holder<\/h2>\n\n\n\n

                  Novartis Europharm Limited<\/p>\n\n\n\n

                  Vista Building<\/p>\n\n\n\n

                  Elm Park, Merrion Road<\/p>\n\n\n\n

                  Dublin 4<\/p>\n\n\n\n

                  Ireland<\/p>\n\n\n\n

                  Manufacturer<\/strong><\/p>\n\n\n\n

                  Novartis Pharma GmbH<\/p>\n\n\n\n

                  Roonstrasse 25<\/p>\n\n\n\n

                  90429 Nuremberg<\/p>\n\n\n\n

                  Germany<\/p>\n\n\n\n

                  Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n

                  Belgium \/ Belgique \/ Belgien<\/strong>Novartis Pharma NVTel: +32 2 246 16 11<\/td>Lithuania<\/strong>SIA “Novartis Baltics” Lithuanian branchesTel: +370 5 269 16 50<\/td><\/tr>
                  Bulgaria<\/strong>Novartis Bulgaria EOODTel: +359 2 489 98 28<\/td>Luxembourg \/ Luxemburg<\/strong>Novartis Pharma NVTel: +32 2 246 16 11<\/td><\/tr>
                  Czech Republic<\/strong>Novartis sroTel: +420 225 775 111<\/td>Hungary<\/strong>Novartis Hungary Kft.Tel .: +36 1 457 65 00<\/td><\/tr>
                  Denmark<\/strong>Novartis Healthcare A \/ STel: +45 39 16 84 00<\/td>Malta<\/strong>Novartis Pharma Services Inc.Tel: +356 2122 2872<\/td><\/tr>
                  Germany<\/strong>Novartis Pharma GmbHTel: +49 911 273 0<\/td>The Netherlands<\/strong>Novartis Pharma BVTel: +31 26 37 82 111<\/td><\/tr>
                  Eesti<\/strong>SIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810<\/td>Norway<\/strong>Novartis Norge ASTel: +47 23 05 20 00<\/td><\/tr>
                  Greece<\/strong>Novartis (Hellas) AEBE:\u0397\u03bb: +30 210 281 17 12<\/td>Austria<\/strong>Novartis Pharma GmbHTel: +43 1 86 6570<\/td><\/tr>
                  Spain<\/strong>Novartis Pharmac\u00e9utica, SATel: +34 93 306 42 00<\/td>Poland<\/strong>Novartis Poland Sp. z ooTel .: +48 22 375 4888<\/td><\/tr>
                  France<\/strong>Novartis Pharma SASTel: +33 1 55 47 66 00<\/td>Portugal<\/strong>Novartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600<\/td><\/tr>
                  Croatia<\/strong>Novartis Hrvatska dooTel. +385 1 6274 220<\/td>Romania<\/strong>Novartis Pharma Services Romania SRLTel: +40 21 31299 01<\/td><\/tr>
                  Ireland<\/strong>Novartis Ireland LimitedTel: +353 1 260 12 55<\/td>Slovenia<\/strong>Novartis Pharma Services Inc.Tel: +386 1 300 75 50<\/td><\/tr>
                  Iceland<\/strong>Vistor hf.Phone: +354 535 7000<\/td>Slovak Republic<\/strong>Novartis Slovakia sroTel: +421 2 5542 5439<\/td><\/tr>
                  Italy<\/strong>Novartis Farma SpATel: +39 02 96 54 1<\/td>Finland \/ Finland<\/strong>Novartis Finland OyPuh \/ Tel: +358 (0) 10 6133 200<\/td><\/tr>
                  .\u03a0\u03c1\u03bf\u03c2<\/strong>Novartis Pharma Services Inc.:\u0397\u03bb: +357 22 690 690<\/td>Sweden<\/strong>Novartis Sverige ABTel: +46 8 732 32 00<\/td><\/tr>
                  Latvia<\/strong>SIA \u201cNovartis Baltics\u201dTel: +371 67 887 070<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"

                  Luxturna is a gene therapy preparation with the active substance voretigen neparvovek.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,15579],"tags":[16654,16649,16650,16653,16644,16647,16648,16651,16645,16652,16646],"class_list":["post-17230","post","type-post","status-publish","format-standard","hentry","category-medicines","category-l","tag-benefits-of-luxturna","tag-benefits-of-voretigen-neparvovek","tag-luxturna","tag-luxturna-side-effects","tag-voretigen-neparvovek","tag-voretigen-neparvovek-injection","tag-voretigen-neparvovek-side-effects","tag-what-is-luxturna","tag-what-is-voretigen-neparvovek","tag-what-luxturna-is-used-for","tag-what-voretigen-neparvovek-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/17230","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=17230"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/17230\/revisions"}],"predecessor-version":[{"id":17286,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/17230\/revisions\/17286"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=17230"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=17230"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=17230"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}