Revakinagene taroretcel ophthalmic

Revakinagene taroretcel is used to treat adults with an eye condition called idiopathic macular telangiectasia type 2.

Revakinagene taroretcel ophthalmic may also be used for reasons not mentioned in this medication guide.

Revakinagene taroretcel is placed as an implant into your eye. This procedure will be done in your ophthalmologist's (eye doctor) office or another clinic.

Your doctor will confirm that revakinagene taroretcel is the right treatment for you.

You will receive a Patient card about your eye implant. Show this card to your imaging technician if you need Magnetic Resonance Imaging (MRI) for important safety information. Keep the card with you at all times.

Make sure to not miss any follow-up appointments with your doctor.

Tell the doctor in advance that you have a revakinagene taroretcel implant before any vision exam.

You may be given other medications to help prevent serious side effects or infection after the procedure. Keep taking these medicines for as long as your doctor has prescribed.

You may have difficulty seeing when moving from a bright to a dark environment. Consider using flashlights or nightlights at home. Wear protective eyewear (like sunglasses) during the day and use an eye shield at night for one week after the procedure.

Tell your doctor if you use other medicines or have other medical conditions or allergies.

You should not receive revakinagene taroretcel if you are allergic to Endothelial Serum Free Media (Endo-SFM), or if you have:

• an active or suspected infection in or around your eye.

Tell your doctor if you have any active or suspected infection.

It is not known if revakinagene taroretcel will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed after using revakinagene taroretcel ophthalmic.

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

Revakinagene taroretcel may cause some side effects after the procedure. Call your doctor immediately if you have: worsening eye swelling, redness, severe discomfort, crusting, discharge, a cloudy or hazy appearance over your eye or in your vision, seeing halos around lights, seeing flashes of light, vision loss, bleeding inside your eye, increased sensitivity to light, irritation, or other surgical complications such as discomfort due to the implant moving out of place (implant extrusion).

Common side effects of revakinagene taroretcel ophthalmic may include:

• eye pain, redness, discharge, dryness, itching or irritation;
• feeling like something is in your eye;
• trouble seeing in the dark;
• seeing "floaters" in your vision; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Macular Telangiectasia:

1 implant per affected eyeComments:-Each implant contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant 129 human ciliary neurotropic factor, a neurotrophic factor.Use: For the treatment of patients with idiopathic macular telangiectasia type 2

Call your doctor for instructions if you miss an appointment for your revakinagene taroretcel ophthalmic implant.

In a medical setting, an overdose would be treated quickly.

Avoid getting water in your eyes and do not lift anything heavy (over 20 pounds) for one week after the eye procedure.

revakinagene taroretcel ophthalmic may cause blurred vision. Do not drive, engage in hazardous activities, or walk in the dark until the eye shield has been removed and your doctor tells you that your vision has recovered.

Tell your doctor about all your other medicines, especially:

• if you use a blood thinner (like warfarin) or a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen.

Other drugs may affect revakinagene taroretcel ophthalmic, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.