Person living with sickle cell disease taking photos with their caregiver
Be Informed

Safety and Side Effects of CASGEVY®

People living with SCD pictured may or may not have received CASGEVY.

Kiarra, living with SCD, and her grandmother, Tanique

Kiarra, living with SCD, and her grandmother, Tanique

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People living with SCD pictured may or may not have received CASGEVY.

Everyone who received CASGEVY in the clinical study (44 patients) was monitored for safety.

Safety was measured throughout the study. It will continue to be monitored in the long-term study.

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After treatment with CASGEVY, you will have fewer blood cells for a while until CASGEVY takes hold (engrafts) into your bone marrow. This includes low levels of platelets (cells that usually help the blood to clot) and white blood cells (cells that usually fight infections). Your healthcare provider will monitor this and give you treatment as required. The healthcare provider will tell you when blood cell levels return to safe levels.

Tell your healthcare provider right away if you get any of the following symptoms:

  • fever
  • chills
  • infections
  • severe headache
  • abnormal bruising
  • prolonged bleeding
  • bleeding without injury such as nosebleeds; bleeding from gums; blood in your urine, stool, or vomit; or coughing up blood

The most common side effects of CASGEVY include:

  • Low levels of platelet cells, which may reduce the ability of blood to clot and may cause bleeding
  • Low levels of white blood cells, which may make you more susceptible to infection
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Your healthcare provider will test your blood to check for low levels of blood cells (including platelets and white blood cells).

Exclamation mark in triangle representing safety and side effects in the clinical study

These are not all the possible side effects of CASGEVY. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

These are not all the possible side effects of CASGEVY. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Safety considerations from the clinical study

Icon to show no cases of graft-versus-host disease, graft failure, or graft rejection

In the clinical study there were no cases of graft-versus-host disease, graft failure, or graft rejection with CASGEVY. The side effects were similar to what would be expected from busulfan myeloablative conditioning and stem cell transplant.

 

Icon representing person sitting in infusion chair receiving conditioning before receiving CASGEVY® (exagamglogene autotemcel) at the ATC

After receiving the conditioning medicine, which is a form of chemotherapy, it may not be possible for you to become pregnant or father a child. You should discuss options for fertility preservation with your healthcare provider before treatment.

You may experience side effects associated with other medicines administered as part of the treatment regimen with CASGEVY. Talk to your healthcare provider regarding those possible side effects. Your healthcare provider may give you other medicines to treat your side effects.

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Start the CASGEVY conversation

Talking with your healthcare provider and loved ones is an important step when considering CASGEVY.

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Have questions about CASGEVY?

Find answers to some of the most common questions patients and caregivers ask.