Luxturna | Luxturna gene therapy | 100% Good Quality

$171,700.00

LUXTURNA (voretigene neparvovec-rzyl) is a prescription gene therapy product used for the treatment of patients with inherited retinal disease due to mutations in both copies of the RPE65 gene, which can only be confirmed through genetic testing. You must also have enough remaining cells in your retina (the thin layer of tissue in the back of your eyes) as determined by your healthcare professional. Luxturna gene therapy.

Description

Generic name: voretigene neparvovec ophthalmic (voe RET i jeen ne PAR voe vek off THAL mik)
Brand name: Luxturna
Drug class: Miscellaneous ophthalmic agents

What is Luxturna? | Luxturna | Luxturna gene therapy

Luxturna (for use in the eyes) is used to treat diseases of the retina that can cause night blindness, light sensitivity, and progressive vision loss.

Luxturna is for use only in people with a specific gene mutation. Before you receive Luxturna, you will need a medical test to make sure you have this gene mutation.

Your doctor will also determine whether you have enough remaining cells in your retina to be safely treated with this medicine.

Luxturna may also be used for purposes not listed in this medication guide.

Luxturna is a medicine that is used to treat adults and children with loss of vision due to inherited retinal dystrophy, a rare genetic disorder of the retina (the light sensitive membrane at the back of the eye). Luxturna gene therapy

Luxturna can only be used while patients still have enough functioning cells left in the retina and when the disease is caused by mutations (changes) in the gene RPE65RPE65 is responsible for the production of an enzyme called all-trans retinyl isomerase, which is necessary for the normal functioning of retinal cells.

Luxturna contains the active substance voretigene neparvovec and is a type of advanced therapy medicine called a ‘gene therapy product’. This is a type of medicine that works by delivering genes into the body. Luxturna gene therapy

Inherited retinal dystrophy is rare, and Luxturna was designated an ‘orphan medicine’ (a medicine used in rare diseases) for two forms of the disease on various dates (retinitis pigmentosa: 28 July 2015; Leber’s congenital amaurosis: 2 April 2012). Luxturna gene therapy

How is Luxturna used?

Luxturna can only be obtained with a prescription and treatment should be given by a surgeon experienced in performing eye surgery.

Luxturna is given as a single injection into the back of each eye, under the retina. The second eye should be treated at least 6 days after the first. Patients should start receiving immunosuppressant medicines (medicines that reduce the activity of the immune system, the body’s natural defences) 3 days before Luxturna is injected into the first eye, to lower the risk of the medicine being rejected by the body, and this treatment should continue for 14 days after injection. Luxturna gene therapy

For more information about using Luxturna, see the package leaflet or contact your doctor or pharmacist.

How is Luxturna used?
Luxturna can only be obtained with a prescription and treatment should be given by a surgeon experienced in performing eye surgery.

Luxturna is given as a single injection into the back of each eye, under the retina. The second eye should be treated at least 6 days after the first. Patients should start receiving immunosuppressant medicines (medicines that reduce the activity of the immune system, the body’s natural defences) 3 days before Luxturna is injected into the first eye, to lower the risk of the medicine being rejected by the body, and this treatment should continue for 14 days after injection. Luxturna gene therapy

For more information about using Luxturna, see the package leaflet or contact your doctor or pharmacist.

How does Luxturna work?
Luxturna consists of a virus that contains normal copies of the RPE65 gene. When Luxturna is injected into the eye the virus carries the RPE65 gene into the retinal cells and enables them to produce the missing enzyme. This helps the cells in the retina to function better, slowing down the progression of the disease. Luxturna gene therapy

The type of virus used in this medicine (adeno-associated virus) does not cause disease in humans.

What benefits of Luxturna have been shown in studies?
Luxturna was investigated in one main study involving 31 patients with inherited retinal dystrophy due to RPE65 mutations. The main measure of effectiveness was how well patients performed in a mobility test, where they were required to navigate a route with turns and obstacles under various light settings. Patients were considered to have passed the test if they completed the route within 3 minutes and bumped into no more than 3 obstacles. Luxturna gene therapy

After one year of treatment, patients treated with Luxturna improved their scores by 1.8 points, while patients who were not given Luxturna improved their scores by 0.2 points, meaning that patients treated with Luxturna were able to move better along the route. Additionally, 13 of the 21 patients (62%) treated with Luxturna passed the mobility test at the lowest light level of 1 lux (similar to conditions of a poorly lit pavement at night), while none of the patients not given the medicine were able to do so. The improvement in patients’ vision was maintained for at least three years. Luxturna gene therapy

What are the risks associated with Luxturna?
The most common side effects with Luxturna (which may affect more than 1 in 20 people) are conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye), cataract (clouding of the lens of the eye) and increased pressure inside the eye. For the full list of side effects of Luxturna, see the package leaflet. Luxturna gene therapy

Luxturna must not be used in patients with eye infection or inflammation. For the full list of restrictions, see the package leaflet.

Why is Luxturna authorised in the EU?
Luxturna has been shown to improve patients’ vision and ability to move around obstacles, particularly in dim light, and is expected to improve their quality of life. This was considered an important clinical benefit, taking into account the lack of authorised treatments for this progressive, degenerative condition. The safety of Luxturna was considered acceptable and side effects manageable. Therefore, the European Medicines Agency decided that Luxturna’s benefits are greater than its risks and it can be authorised for use in the EU. Luxturna gene therapy

What measures are being taken to ensure the safe and effective use of Luxturna?
The company that markets Luxturna will set up an educational programme and prepare educational material aimed at doctors and pharmacists expected to use and handle Luxturna, in order to ensure the correct use of the medicine and minimise the risks associated with the medicine and its administration. Luxturna gene therapy

Luxturna will only be available from centres where the educational programme is in place. An information package for patients and their carers will also be provided. Luxturna gene therapy

In addition, the company will have to follow-up all patients who received Luxturna in the main studies for 15 years, in order to characterise the long-term effectiveness and safety of the medicine, and establish a registry to collect long-term safety data in patients treated with Luxturna.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Luxturna have also been included in the summary of product characteristics and the package leaflet. Luxturna gene therapy

As for all medicines, data on the use of Luxturna are continuously monitored. Side effects reported with Luxturna are carefully evaluated and any necessary action taken to protect patients. Luxturna gene therapy

Luxturna side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Voretigene neparvovec can cause changes in your retina that could lead to vision loss, including:

  • new or worsening cataract (clouding of the lens inside of the eye);
  • thinning of the clear layer in front of your eye;
  • deposits under your retina;
  • separating layers or a developing hole in the center of your retina;
  • thinning of the retina or loss of function;
  • breaks or wrinkling on the surface of your retina;
  • retinal detachment;
  • bleeding in the retina; or
  • permanent decline in the sharpness of your vision.

Talk to your doctor about the risks and benefits of Luxturna.

Call your doctor at once if you have:

  • new or worsening vision problems;
  • eye pain;
  • flashes of light or “floaters” in your vision, seeing halos around lights; or
  • signs of eye infection–eye pain or swelling, headache, increased sensitivity to light, crusting or drainage, vision loss.

Common side effects may include:

  • eye pain, swelling, or redness;
  • cataract (cloudy appearance in the eye);
  • swelling of the eyelids; or
  • increased pressure inside the eye.

Reviews

There are no reviews yet.

Be the first to review “Luxturna | Luxturna gene therapy | 100% Good Quality”

Your email address will not be published.