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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.

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