Luxturna

Luxturna is a prescription medication used to treat patients with retinal dystrophy, or wasting, caused by a genetic mutation.

Luxturna belongs to a group of drugs called gene therapy. Gene therapy is a method for treating a genetic disease that delivers a new or functional gene into a cell.

This medication is available in an injectable form to be given into the eye by a healthcare professional.

Common side effects of Luxturna include eye redness, cataract, and increased eye pressure. Luxturna can also cause blurred vision. Do not drive or operate heavy machinery until you know how Luxturna affects you.

Luxturna is a prescription medication used to treat patients with retinal dystrophy, or wasting, caused by RPE65 mutation. Luxturna can only be used in patients with working retinal cells.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Luxturna. See the “Luxturna Precautions” section.

Common side effects of Luxturna include the following:

• eye redness
• cataract
• increased eye pressure
• retina tear
• thinning of the cornea, a transparent layer of the front of the eye
• hole in the back of the eye
• deposits below the retina
• eye inflammation, irritation, or pain
• wrinkling of the back of the eye

This is not a complete list of Luxturna side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Luxturna including the following:

• endophthalmitis, or inflammation of the interior of the eye. Tell your healthcare provider if you have any changes in vision, eye pain or irritation, and floaters appear in the eye.
• a permanent decline in visual acuity. Tell your healthcare provider if you have any changes or disturbances in vision.
• retinal abnormalities. Your healthcare provider will monitor you for any retinal abnormalities. Tell your healthcare provider if you have any signs or symptoms of a retinal tear, including decreased vision, blurred vision, and any floaters or specks in your field of vision.
• increased eye pressure. Follow-up with your healthcare provider for monitoring.
• increased size of air bubbles in the eye with a change in air pressure. After receiving Luxturna, you should avoid any air travel, traveling to high elevations, or scuba diving until air bubble has disappeared. Your healthcare provider will tell you when it is okay to resume these activities.
• cataract. Tell your healthcare provider if you have any signs or symptoms of a cataract including sensitivity to light, difficulty with vision at night, fading or yellowing of colors, seeing halos around the lights, and clouded, blurred, or dimmed vision.

Luxturna can cause blurred vision. Do not drive or operate heavy machinery until you know how Luxturna affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Luxturna there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Luxturna, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Luxturna or to any of its ingredients
• have or have had an eye problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Luxturna.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Luxturna crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Luxturna.

This medication is available in an injectable form to be given into the eye by a healthcare professional.

Your healthcare provider may prescribe prednisone or an equivalent medication for 7 days (starting 3 days before administration of Luxturna to each eye), and followed by a tapering dose during the next 10 days.

The recommended dose of Luxturna for the treatment of retinal dystrophy, or wasting, is 0.3 mL.

If Luxturna is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep all appointments with your doctor.