Betibeglogene autotemcel is used to treat beta-thalassemia (Cooley's Anemia) in people at least 4 years old who need blood transfusions often.

Betibeglogene autotemcel may also be used for purposes not listed in this medication guide.

Call your doctor at once if you have severe headache, abnormal bruising, nosebleeds, blood in your urine or stool, stomach pain, back pain, or if you cough up blood or vomit.

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

Betibeglogene autotemcel is injected into a vein by a healthcare provider. You will be given other medicines as part of your treatment with betibeglogene autotemcel.

After betibeglogene autotemcel injection, you will stay in the hospital for approximately 3 to 6 weeks to monitor your recovery. Your doctor will determine when you can go home.

This medicine may cause false results on a HIV (human immunodeficiency virus) test. Tell the laboratory staff that you use betibeglogene autotemcel.

Your blood will need to be tested often.

Ask a doctor or pharmacist before using betibeglogene autotemcel if you have health problems or use other medications.

Do not use if you are pregnant. Use effective birth control while using betibeglogene autotemcel and for at least 6 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed.

Betibeglogene autotemcel may affect fertility in men or women. Ask your doctor about saving semen and eggs before treatment.

Call your doctor for instructions if you miss an appointment for your betibeglogene autotemcel injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

You should not receive a "colony stimulating factor" medicine such as filgrastim (Neupogen, Granix, Zarxio), pegfilgrastim (Neulasta), or sargramostim (Leukine) within 21 days after the betibeglogene autotemcel injection.

Avoid donating blood, organs, tissues or cells.

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

Betibeglogene autotemcel may cause serious side effects. Call your doctor at once if you have:

• fast heart rate;

• severe headache;

• nosebleeds;

• blood in your stool or urine;

• unusual stomach or back pain;

• if you are vomiting or coughing up blood;

• easy bruising, unusual bleeding, purple or red spots under your skin; or

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough.

Common side effects of betibeglogene autotemcel may include:

• fast heart rate;

• stomach pain;

• pain in your arms or legs;

• easy bruising, unusual bleeding, purple or red spots under your skin; or

• low white blood cell counts.

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.

Tell your doctor about all your other medicines, especially:

• iron chelators such as deferoxamine, deferasirox, or deferiprone;

• HIV/AIDS medications; or

• hydroxyurea.

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