Betibeglogene Autotemcel Injection

What is this medication?

BETIBEGLOGENE AUTOTEMCEL (be ti BEG loe jeen aw toe TEM sel) treats beta thalassemia. It works by helping your body make healthy red blood cells, which reduces the need for blood transfusions.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ZYNTEGLO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• HIV or AIDS
• Recent or upcoming vaccination
• An unusual or allergic reaction to betibeglogene autotemcel, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting. This medication is made from your own immune cells.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 4 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

What may interact with this medication?

• Granulocyte-colony stimulating factor
• Iron chelator medications
• Live virus vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular health checks while on this medication. It is important for you to have regular check-ups and blood work done for at least 15 years after this treatment.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

If you need an HIV test, talk to your care team about which test to use. This medication may cause a false-positive result if certain tests are used.

Do not donate blood, organs, tissues, or cells any time after receiving this treatment.

Talk to your care team if you may be pregnant. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for at least 6 months after your last dose. Your care team can help you find the option that works for you.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

If your partner can get pregnant, use a condom during sex while taking this medication and for at least 6 months after the last dose.

The conditioning medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Infection—fever, chills, cough, or sore throat

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Bone pain
• Change in skin color
• Fast or irregular heartbeat
• Fever
• Hair loss
• Muscle pain
• Nosebleed
• Pain, redness, or swelling with sores inside the mouth or throat
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.