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WHAT IS REVCOVI?

Revcovi is the only FDA-approved enzyme replacement therapy (ERT) for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID). Revcovi replaces the ADA enzyme in people with ADA-SCID—infants, children, and adults.

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HOW REVCOVI WORKS

Revcovi helps do the job of the ADA enzyme: removing the leftover material from cells dividing.

If the leftover material is removed, it can’t build up and form toxic dAXP. And without dAXP, the body can produce more lymphocytes to fight off infections. 

YOUR DOCTOR MAY RECOMMEND REVCOVI IF YOU USED TO BE ON A DIFFERENT ERT

You may have heard of, or previously received, an ERT called Adagen® (pegademase bovine) for ADA-SCID. Adagen is no longer available, but Revcovi was designed to replace it.

TAKING REVCOVI

2 times a week, intramuscular injection, at home or at a doctor 2 times a week, intramuscular injection, at home or at a doctor 2 times a week, intramuscular injection, at home or at a doctor

YOU CAN TAKE REVCOVI AT HOME

If you'd like to take Revcovi at home, your doctor can show you how. You can also have your doctor administer it to you in their office.

How to store Revcovi

  • Store in the refrigerator between 2°C and 8'C (36'F to 46'F) in original carton to protect from light
  • Do not freeze or shake. Do not use if any indication that vial may have been frozen
  • Do not reuse the vial. Throw away unused portions
  • Throw away if solution is discolored, cloudy, or contains particles

HOW WILL YOU KNOW WHEN REVCOVI IS WORKING?

Revcovi is designed to help replace the ADA enzyme. It’s meant to decrease levels of dAXP in your blood, improve ADA activity throughout your body, and increase lymphocyte numbers in your blood.

To see if Revcovi is working for you, your doctor will keep track of these levels in your blood.

dAXP going down
dAXP is a toxic substance that damages and removes lymphocytes.

Lymphocytes going up
Lymphocytes help your body fight infection.

ADA activity going up
The ADA enzyme helps your immune system work normally.

REVCOVI WORKS TO HELP KEEP YOUR IMMUNE SYSTEM FUNCTIONING NORMALLY.

Most patients have improved immune system function by 24 weeks. It’s important to stay on treatment so that Revcovi can help your immune system continue doing what it’s supposed to do: fighting off the infections that ADA-SCID may cause.

Important Safety Information

Warnings and Precautions:

  • If you have lower than normal platelet counts, you may be at increased risk of bleeding at the injection site. Your doctor should not prescribe Revcovi if you have severely low blood platelet counts.
  • There may be a delay in improvement of your immune system’s function after starting Revcovi treatment. During this delay, it is important to be protected from exposure to infections until your immune system improves.

What are the possible side effects of Revcovi?

  • Cough and vomiting were the most common side effects reported by patients receiving Revcovi.
  • Based on reports of side effects of other enzyme replacement therapies used to treat ADA-SCID, which are similar to Revcovi, patients taking Revcovi may also experience:
    • Blood and blood cell–related problems: red blood cells being destroyed faster than they can be made, resulting in anemia; and higher or lower than normal number of platelets in the blood
    • Skin-related problems: redness and itching at the injection site
    • Cancers of the immune system called lymphomas

What types of monitoring will be needed while I am taking Revcovi?

  • Continuous therapy and adherence to the recommended drug schedule is important for the success of the treatment.
  • While you are being treated with Revcovi, your doctor will need to do blood tests to monitor the levels of ADA activity and metabolites and overall immune function.
  • This monitoring will ensure you are maintaining appropriate levels for therapeutic benefit. If an ongoing decline in your blood’s measured adenosine deaminase (ADA) activity occurs, your immune function and clinical status will be monitored closely and precautions will be taken to help reduce your risk of infection.

What is known about taking Revcovi during pregnancy?

  • If you are pregnant or planning to become pregnant, or breastfeeding or planning to breastfeed, please talk to your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication

Revcovi® (elapegademase-lvlr) is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.

Please see the Full Prescribing Information.

Important Safety Information

Warnings and Precautions:

  • If you have lower than normal platelet counts, you may be at increased risk of bleeding at the injection site. Your doctor should not prescribe Revcovi if you have severely low blood platelet counts.
  • There may be a delay in improvement of your immune system’s function after starting Revcovi treatment. During this delay, it is important to be protected from exposure to infections until your immune system improves.

What are the possible side effects of Revcovi?

  • Cough and vomiting were the most common side effects reported by patients receiving Revcovi.
  • Based on reports of side effects of other enzyme replacement therapies used to treat ADA-SCID, which are similar to Revcovi, patients taking Revcovi may also experience:
    • Blood and blood cell–related problems: red blood cells being destroyed faster than they can be made, resulting in anemia; and higher or lower than normal number of platelets in the blood
    • Skin-related problems: redness and itching at the injection site
    • Cancers of the immune system called lymphomas

What types of monitoring will be needed while I am taking Revcovi?

  • Continuous therapy and adherence to the recommended drug schedule is important for the success of the treatment.
  • While you are being treated with Revcovi, your doctor will need to do blood tests to monitor the levels of ADA activity and metabolites and overall immune function.
  • This monitoring will ensure you are maintaining appropriate levels for therapeutic benefit. If an ongoing decline in your blood’s measured adenosine deaminase (ADA) activity occurs, your immune function and clinical status will be monitored closely and precautions will be taken to help reduce your risk of infection.

What is known about taking Revcovi during pregnancy?

  • If you are pregnant or planning to become pregnant, or breastfeeding or planning to breastfeed, please talk to your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication

Revcovi® (elapegademase-lvlr) is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.

Please see the Full Prescribing Information.

References available upon request.

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