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Overview: Zevaskyn is used for skin wounds in people with a rare genetic disorder that causes very fragile skin. The therapy is made by changing your own skin cells to help your wound(s) heal. The most common side effects are pain and itchiness during the healing process. Rare but serious side effects may include infection, allergic reaction, and a higher chance of cancer. Zevaskyn is a sheet that is applied to the skin by a health care provider.

Uses

What is Zevaskyn used for?

Zevaskyn (prademagene zamikeracel) is commonly used to treat wounds in people with recessive dystrophic epidermolysis bullosa (RDEB), which is a rare genetic disorder that causes very fragile skin.

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

How does Zevaskyn work (mechanism of action)?

Zevaskyn is a type of gene therapy made from a person’s own skin cells. In the lab, these cells are changed to include a healthy version of the gene that people with recessive dystrophic epidermolysis bullosa are missing. The changed cells are placed on a special sheet that is applied to a skin wound like a bandage. The changed cells help skin wounds to heal because they are able to make a type of protein that is needed to form a good connection between your skin layers. 

How is Zevaskyn supplied (dosage forms)?

Zevaskyn is available in a sheet that is applied to the skin by a health care provider. 

How should I store Zevaskyn?

Zevaskyn is applied to the skin by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Zevaskyn?

The most common side effects of Zevaskyn are pain and itching at the treated area of your skin. Tell your health care provider if you have any of these side effects that bother you.

There may be other side effects of Zevaskyn 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 Zevaskyn?

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

Severe Allergic Reactions. Zevaskyn 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, runny nose, or watery eyes
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Risk of Infection. The process to make Zevaskyn involves the use of human and animal substances. It is possible that these substances may carry germs that can cause infections. While steps are taken to reduce this risk, there is still a small chance you could get an infection. Some infections may not cause symptoms. Keep all medical appointments after Zevaskyn is applied, so your health care provider can monitor your health. Talk with your health care provider about any concerns you may have.

Warnings & Precautions

Who should not use Zevaskyn?

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

  • Zevaskyn
  • Prademagene zamikeracel
  • Any of the ingredients in the specific product dispensed

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

What should I know about Zevaskyn before using it?

Zevaskyn is applied to your skin by a health care provider in a hospital. 

Keep all appointments with your health care provider after Zevaskyn is applied. It is normal to have pain and itchiness in the treated area while the wound is healing. Tell your health care provider right away if you have a fever, oozing, swelling, unusual changes, or pain that is getting worse at the treated area.

Keep the surgical dressings in place for five to ten days after Zevaskyn is applied, as directed by your health care provider. Try to keep the dressings dry. Do not place or dunk the treated area in water until the gauze falls off on its own. It usually falls off within a few weeks. 

In some cases, the lab may not be able to make your Zevaskyn treatment from your first skin sample. If this happens, you may need to get a new biopsy done to try again.  

There is a very small risk that Zevaskyn could increase your chance of getting cancer because of how your cells are changed to make this medicine. Your health care provider will monitor you over time to check for any signs of cancer. Tell your health care provider about any new symptoms you may get. 

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

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 Zevaskyn is right for you.

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

Pregnancy. It is not known if or how Zevaskyn could affect pregnancy or harm an unborn baby. If you can get pregnant, it is recommended to use effective birth control at the time of Zevaskyn treatment. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Zevaskyn passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. 

How can I get more information about Zevaskyn?

For more information about Zevaskyn, you can visit the drugmaker’s website at www.zevaskyn.com or call them at 855-223-6621.

Interactions

Does Zevaskyn interact with foods or drinks?

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

It is unknown if drinking alcohol will affect Zevaskyn.

Does Zevaskyn interact with other medicines (drug interactions)?

There are no known interactions between Zevaskyn and other medicines. 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.

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 Zevaskyn?

If you or someone else has used too much Zevaskyn, 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 Zevaskyn?

Zevaskyn is applied by a health care provider in a hospital or clinic. If you miss your appointment to get your Zevaskyn treatment, call your health care provider’s office as soon as possible.