Betibeglogene Autotemcel (be-ti-BEG-loe-jeen aw-toe-TEM-sel)

Treats beta thalassemia in patients who need regular blood transfusions.

Brand Name(s):

Zynteglo

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. This medicine must be given slowly, so your IV tube will need to stay in place for at least 4 hours.
• A nurse or other health provider will give you this medicine.
• You may also receive other medicines (including cancer 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 3 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 hydroxyurea or medicine to treat HIV for at least 1 month before having a procedure to collect your blood.
• Do not use iron chelators for at least 7 days before receiving a cancer medicine and for 6 months after receiving this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 6 months after the last dose.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have kidney disease or liver disease.
• 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.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• 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
• Bone, muscle, arm, or leg pain
• Fast heartbeat, stomach pain
• Fever, chills, cough, sore throat, body aches
• Unusual bleeding, bruising, or weakness

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

• Changes in skin color
• Constipation, diarrhea, nausea, vomiting, loss of appetite
• Hair loss
• Headache
• 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