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Betibeglogene Autotemcel Injection (BETIBEGLOGENE AUTOTEMCEL - INJECTION)

For anemia.

Brand Name(s): Zynteglo

Generic Name: Betibeglogene Autotemcel

Instructions

This is an IV medicine. It is given through a sterile tube directly into the vein by a healthcare provider.

This medicine is given gradually through the IV line.

This medicine should be given by a trained health care provider.

You must be monitored by a health care professional during and after each dose is given.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

This medicine is usually combined with another medicine to treat your condition.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine may increase the risk of cancer. Ask your doctor about the benefits and risks.

There is an increased risk of bleeding while on this medicine, please tell your doctor or nurse if you notice any excessive bleeding or bruising.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while taking this medicine and for 6 months after stopping to prevent pregnancy.

Men with a female partner who is of childbearing age must use reliable birth control during sexual activity while taking this medicine and for 6 months after stopping to prevent pregnancy.

Do not donate blood, organs, tissues, or cells after using this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • pain in the abdomen
  • decreased appetite
  • constipation or diarrhea
  • hair loss
  • headaches
  • mouth sores or irritation
  • joint or muscle pain
  • nausea and vomiting
  • pain in arms or legs
  • rapid heartbeat
  • red, burning, or itchy skin
  • stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • bleeding or bruising
  • cough that does not go away
  • coughing up blood or vomit that looks like coffee grounds
  • nosebleeds
  • fever or chills
  • severe or persistent headache
  • pale or blue skin, lips or fingernails
  • sore throat
  • bloody or dark, tarry stools
  • unusual or unexplained tiredness or weakness

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.