Lisocabtagene Maraleucel Injection (LISOCABTAGENE MARALEUCEL - INJECTION)

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.

Use effective birth control to avoid pregnancy.

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.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive, operate machinery, or do anything else that requires alertness for at least 8 weeks after you use this medicine.

Please check with your doctor before drinking alcohol while on this medicine.

Call the doctor if there are any signs of confusion or unusual changes in behavior.

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.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

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

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

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

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

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.

• agitated feeling or trouble sleeping
• decreased appetite
• lack of energy and tiredness
• headaches

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

• loss of balance
• bleeding or bruising
• confusion
• cough that does not go away
• severe, watery or bloody diarrhea
• difficulty moving muscles of the face and eyes
• difficulty reading or writing
• dizziness or drowsiness
• fever or chills
• numbness or tingling in hands and feet
• fast or irregular heart beats
• signs of kidney damage (such as change in urine color or bubbly urine)
• lightheadedness
• memory problems or loss
• joint or muscle pain
• nervousness
• seizures
• shakiness
• shortness of breath
• sore throat
• difficulty speaking
• swollen glands
• unusual or unexplained tiredness or weakness
• severe or persistent vomiting

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.