Exagamglogene Autotemcel (ex-a-GAM-gloe-jeen aw-toe-TEM-sel)

Treats sickle cell disease and beta thalassemia.

Brand Name(s):

Casgevy

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• You may also receive other medicines (including fever medicine or allergy medicine,) before receiving this medicine.
• This medicine is made specifically for each patient, using the patient's own blood cells. Your doctor will collect your blood through a procedure called mobilization and apheresis. Talk with your doctor if you have any concerns about this.
• Your doctor will also want you to stay in the hospital or center for at least 4 to 6 weeks after your infusion.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use crizanlizumab, hydroxyurea, and voxelotor for at least 8 weeks and an iron chelator for at least 7 days before having a procedure to collect your blood.

Warnings While Using This Medicine:

• If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before having a procedure to collect your blood. Female patients and male patients with female partners should use an effective form of birth control before having a procedure to collect your blood and for at least 6 months after the last dose.
• Tell your doctor if you are breastfeeding or if you have kidney disease, liver disease, or a history of dimethyl sulfoxide (DMSO) allergy.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Do not donate blood, organs, tissues, or cells during treatment with this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, sore throat, body aches
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Decreased appetite
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088