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?

Your condition will be monitored carefully while you are receiving this medication.

You may need bloodwork while taking this medication.

Do not give blood while taking this medication or after stopping it.

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.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy. A negative pregnancy test is required before starting this medication. A barrier contraceptive, such as a condom or diaphragm, is recommended while taking this medication and for at least 6 months after stopping it. Talk to your care team about other forms of contraception. Talk to your care team before breast-feeding. Changes to your treatment plan may be needed.

Males who get this medication must use a condom during sex with females who can get pregnant. If you get a woman pregnant, there is potential for serious harm to an unborn child. You will need to continue wearing a condom for at least 6 months after stopping the medication. Tell your care team right away if you think your partner might be pregnant.

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.