Revakinagene Taroretcel Implant

What is this medication?

REVAKINAGENE TARORETCEL (REV a KIN a jeen TAR oh RET sel) treats macular telangiectasia (MacTel), a condition that causes the loss of sharp central vision. It works by helping to slow changes in vision. It is a gene therapy.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Encelto

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Infection in or around the eye
• An unusual or allergic reaction to revakinagene taroretcel, endothelial serum free media, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This implant is placed in the eye by your care team in a hospital setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medication?

Interactions are not expected. Do not use any other eye products without talking to your care team.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Follow the instructions given to you by your care team after your procedure.

Tell your care team right away if you have any change in your eyesight. This medication may cause a condition in which your eyes have trouble adjusting to the dark after being in a bright place. Avoid driving at night until your care team tells you it is safe to do so. Use care when moving from bright to dark areas, such as entering a dark room or going outside when it is dark. Wear sunglasses or tinted lenses in bright places. This can help your eye adjust better when you move to a darker area.

Tell your care team if you have an implant and need an MRI. They will need to follow certain conditions to ensure you are safely scanned.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blurry vision, vision loss, seeing wavy or bent objects or blind spots with dark, light, or flashing spots
• Eye pain, redness, irritation, or discharge with blurry or decreased vision
• Vision loss

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Blurry vision
• Dry eyes
• Eye irritation or itching
• Eye redness
• Headache
• Small spots floating in vision

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This implant is placed in a hospital. It will not be stored at home before use.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.