Exagamglogene autotemcel

Exagamglogene autotemcel is used to treat sickle cell disease in adults and children who are at least 12 years old and experience frequent vaso-occlusive crises (pain caused by blocked small blood vessels).

Exagamglogene autotemcel may also be used for reasons not mentioned in this medication guide.

Tell your doctor if you are taking other medicines or have any other medical conditions or allergies.

You may be more likely to get infections or bleed easily. Call your doctor if you have a severe headache, unusual bleeding, or signs of infection (fever, cough, skin sores, painful urination).

Tell your doctor if you have or have ever had:

• hepatitis, HIV or AIDS;
• stem cell transplant; or
• liver or kidney disease.

Tell your doctor if you recently received a vaccine or are scheduled to receive a vaccine.

Exagamglogene autotemcel may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using exagamglogene autotemcel. Talk to your doctor about options for fertility preservation, like sperm banking or egg preservation.

Exagamglogene autotemcel can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine. Ask a doctor if it is safe to breastfeed after using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Tell your medical caregivers right away if you have:

• chills, fever, infections;
• severe headache;
• unusual bruising or bleeding; or
• nosebleeds, bleeding gums, blood in your urine or vomit, bloody or tarry stools, or coughing up blood.

Common side effects of exagamglogene autotemcel may include:

• fever, mouth sores, skin sores, sore throat, cough; or
• easy bruising, unusual bleeding, purple or red spots under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Exagamglogene autotemcel is part of a treatment plan used after a procedure called apheresis, where cells from the blood are removed for stem cell transplant.

Exagamglogene autotemcel is injected into a vein by a healthcare provider.

You may need to stay in the hospital for 4 to 6 weeks after your treatment with exagamglogene autotemcel. Talk with your doctor if you have any questions.

You may be given other medications before your treatment.

Your blood will be tested before and after treatment with exagamglogene autotemcel.

In a medical setting, you are unlikely to miss a dose.

In a medical setting, an overdose would be treated quickly.

Do not donate blood, organs, tissues, or cells for transplantation after receiving exagamglogene autotemcel.

Tell your doctor about all your other medicines, especially:

• disease modifying drugs such as: hydroxyurea, crizanlizumab, voxelotor, and others; or
• iron chelating agents such as: deferasirox, deferiprone, and deferoxamine.

This list is not complete. Other drugs may affect exagamglogene autotemcel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.