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Overview: Encelto is a small implant placed inside the eye by a health care provider to help treat a rare eye disease known as idiopathic macular telangiectasia type 2 (MacTel). Common side effects can include bleeding in your eye, trouble seeing in the dark, feeling like you have something in your eye, and eye pain. Tell your health care provider right away if you have worsening eye pain or any vision changes. If you need to have an MRI, tell your health care provider that you have Encelto in your eye and show them your implant card.

Uses

What is Encelto used for?

Encelto (revakinagene taroretcel-lwey) is an eye implant commonly used for idiopathic macular telangiectasia type 2 (MacTel), which is a rare eye disease that leads to vision loss over time.

Encelto may also be used for other conditions as determined by your health care provider.

How does Encelto work (mechanism of action)?

Encelto is a type of gene therapy. Once placed in the eye, it releases a protein called ciliary neurotrophic factor (CNTF) into the eye. This protein may help protect certain cells in your eye and lower the loss of cells that detect light. 

How is Encelto supplied (dosage forms)?

Brands and other names

  • Encelto

Dosage forms and strengths

Encelto is available as an implant that is placed inside the eye by a health care provider.

How should I store Encelto?

Encelto is placed inside your eye by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

Side Effects

What are the most common side effects of Encelto?

The most common side effects of Encelto are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Blood in the white part of your eye
  • Trouble seeing in the dark (see below)
  • Feeling like something is in your eye
  • Eye pain, discomfort, irritation, itching, redness, or dryness
  • Problems with stitches (see below)
  • Small pupil (the black circle in the center of your eye)
  • Vitreous hemorrhage (see below)
  • Blurry vision or seeing small specks that seem to be floating in your eye
  • Headache
  • Cataracts (see below)

There may be other side effects of Encelto that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Encelto?

While less common, the most serious side effects of Encelto are described below, along with what to do if they happen.

Severe Allergic Reactions. Encelto may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Eye and Retina Problems. Encelto may cause an infection in your eye (endophthalmitis) or cause tears in the retina or separation of layers of the retina, which is part of your eye (retinal tear or retinal detachment). Follow all of the instructions given to you after Encelto is placed inside your eye. Keep all of your follow-up appointments. Call your health care provider right away if you develop any of the following symptoms.

  • Eye redness or pain, especially if it is getting worse
  • Light sensitivity
  • Eye discharge
  • Any change in your vision including lost vision, blurry vision, wavy or distorted vision, increase in small spots or shapes that appear in your vision, or flashing lights

Vitreous Hemorrhage. Placing Encelto inside your eye may cause a vitreous hemorrhage (bleeding inside your eye). This can happen soon after the procedure or even more than a year later. Taking certain medicines around the time of the procedure may increase this risk. See the Interactions section for more details. If a vitreous hemorrhage happens a year or longer after Encelto is placed inside your eye, it may mean that Encelto has moved from where it was originally placed (sometimes called implant extrusion). Call your health care provider right away if you notice any of the following.

  • Dark or moving spots
  • Shapes that look like spider webs in your vision
  • Haze or shadows
  • Floaters

Cataracts. Encelto can cause or worsen cataracts. Cataracts can lead to blindness. Tell your health care provider right away if you have any of the following symptoms.

  • Cloudy or foggy vision
  • Nearsightedness
  • Changes in how you see colors
  • Problems with glare (such as traffic lights when driving at night)
  • Double vision

Trouble Seeing in the Dark. After Encelto is placed inside your eye, you may notice that it takes longer for your eyes to adjust when going from a well lit area to dim light or darkness. This may continue as long as Encelto is inside your eye. It may help to wear sunglasses when in brightly lit areas. Using flashlights, nightlights, or motion lights in the dark may also be helpful. Be careful when going from well lit areas to areas of low light or darkness, especially if you go quickly from lightness to darkness. It may be hard for you to see things or read signs clearly. Talk to your health care provider if you have concerns. 

Problems from Stitches. Stitches are used inside your eye when Encelto is placed. Some problems with stitches are common and may include feeling like something is in your eye, eye itching, or eye pain. Sometimes the stitches can cause sores or other problems inside your eye. Keep all of your appointments after having Encelto placed in your eye, so your health care provider is able to monitor you for any problems.

Warnings & Precautions

Who should not use Encelto?

Allergies to Ingredients. People who are allergic to any of the following should not use Encelto.

  • Encelto
  • Endothelial Serum Free Media (Endo SFM)
  • Revakinagene taroretcel-lwey
  • Any of the ingredients in the specific product 

Your pharmacist can tell you all of the ingredients in Encelto.

Eye Infection. You should not have Encelto placed inside your eye if you have an infection in or around the eye. 

What should I know about Encelto before using it?

Follow the instructions given to you by your health care provider before and after having Encelto placed inside your eye. This may include things like not lifting heavy things, keeping water out of your eye, wearing eye protection (glasses, eye patch, etc), and using certain eye medicines.

After having Encelo placed inside your eye, do not drive or do other activities that require clear vision until you no longer need to wear a cover or shield over your eye and your health care provider tells you that you can. 

If you need to have an MRI, tell your health care provider that you have Encelto in your eye and show them your implant card. The card has important safety information for them to know about before you have the MRI.

What should I tell my health care provider before using Encelto?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Encelto is right for you.

In particular, make sure that you discuss any of the following.

Infection. Tell your health care provider if you have an infection.

Other Medicines and Supplements. Encelto may interact with other medicines and supplements. Before having Encelto put inside your eye, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Encelto could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Encelto passes into breast milk.Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should breastfeed after Encelto is placed in your eye.

How can I get more information about Encelto?

For more information about Encelto, you can visit the drugmaker’s website at www.encelto.com or call them at 401-333-3880.

Interactions

Does Encelto interact with foods or drinks?

There are no known interactions between Encelto and foods or drinks.

It is unknown if drinking alcohol will affect Encelto. Bleeding can happen when Encelto is placed inside your eye. Alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol you drink.

Does Encelto interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before Encelto is placed in your eye.

  • A nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which is in many prescription and OTC products for pain, swelling, and fever
  • A blood thinner, which is a medicine used to treat or prevent blood clots
  • Aspirin, which is in many prescription and OTC products, including those for pain, swelling, and fever

This may not be a complete list of medicines that can interact with Encelto. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Encelto?

If you or someone else has used too much Encelto, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Encelto?

If you miss your appointment to have Encelto placed inside your eye, call to make another appointment as soon as possible.

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