Encelto

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

Encelto may also be used for reasons that are not included in this medication guide.

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 Encelto.

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

Revakinagene taroretcel may cause some side effects following the procedure. Call your doctor right away 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 Encelto 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.

Revakinagene taroretcel is given as an implant into your eye. The procedure will be performed in your ophthalmologist's (eye doctor) office or other clinic setting.

Your doctor will make sure 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 ahead of time 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 problems 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.

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

Encelto 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 the other medicines you are taking, especially:

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

Other drugs can affect Encelto, including both prescription and over-the-counter medicines, vitamins, and herbal products. Make sure to inform your doctor about all the medicines you are using.