Lisocabtagene maraleucel is an immunotherapy medicine used to treat large B-cell lymphoma in adults. Lisocabtagene maraleucel is given after at least two other cancer treatments did not work or have stopped working.

Lisocabtagene maraleucel is made using white blood cells removed from blood that is drawn from your body through a vein.

Lisocabtagene maraleucel may also be used for purposes not listed in this medication guide.

A common but serious side effect of this medicine is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to quickly treat this condition if it occurs.

Lisocabtagene maraleucel is available only at an authorized hospital or clinic, and must be given by specially trained healthcare professionals.

Lisocabtagene maraleucel is given after a procedure called leukapheresis (LOO-kuh-fuh-REE-sis).

During leukapheresis, some of your blood is collected through a small tube (catheter) placed into a vein. The catheter is connected to a machine that separates your white blood cells from other parts of the blood.

The cells are then sent to a laboratory where they are made into lisocabtagene maraleucel. Because it will take time to process your blood cells into lisocabtagene maraleucel, you will not receive the medicine on the same day your blood cells are drawn.

About 2 to 7 days before lisocabtagene maraleucel is given, you will be pre-treated with chemotherapy to help prepare your body for lisocabtagene maraleucel.

Once your body is ready to receive lisocabtagene maraleucel, your care providers will inject the medicine as an infusion into a vein.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

For at least 4 weeks, plan to stay near the hospital or clinic where you received lisocabtagene maraleucel.

Lisocabtagene maraleucel affects your immune system. You may get infections more easily, even serious or fatal infections.

If you've ever had hepatitis B, using lisocabtagene maraleucel can cause this virus to become active or get worse. You may need frequent liver function tests.

Tell your doctor if you have ever had:

• hepatitis B or C; or

• if you have received a vaccine within the past 6 weeks.

Using lisocabtagene maraleucel may increase your risk of developing other cancers. Ask your doctor about this risk.

Tell your doctor if you are pregnant or breastfeeding.

You may need to have a negative pregnancy test before starting this treatment.

Call your doctor for instructions if you miss an appointment for your pre-treatment chemotherapy. The timing of your chemotherapy and lisocabtagene maraleucel injection is very important to the success of your treatment for lymphoma.

Since lisocabtagene maraleucel is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

This medicine can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures. Avoid driving or operating machinery for at least 8 weeks after you are treated with lisocabtagene maraleucel.

Do not donate blood, organs, tissues, or cells for transplantation.

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

A common but serious side effect of lisocabtagene maraleucel is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, dizziness, confusion, vomiting, diarrhea, fast heartbeats, trouble breathing, or feeling very weak or tired. Your caregivers will have medication available to quickly treat CRS if it occurs.

Lisocabtagene maraleucel may cause serious side effects. Call your doctor at once if you have:

• problems with speech;

• confusion, trouble concentrating, memory problems;

• decreased consciousness;

• tremors, or a seizure; or

• signs of infection--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects of lisocabtagene maraleucel may include:

• headache, dizziness;

• confusion, problems with speech or thinking;

• fever, chills, shaking;

• nausea, vomiting, stomach pain;

• diarrhea, constipation;

• fast or irregular heartbeats;

• cough, trouble breathing;

• swelling; or

• pain in your bones, joint, or muscles.

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.

Other drugs may affect lisocabtagene maraleucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.