Tisagenlecleucel is an immunotherapy medicine used to treat a certain type of acute lymphoblastic leukemia in people who are up to 25 years old. tisagenlecleucel is given after other treatments have failed.

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

Tisagenlecleucel is available under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

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

A serious side effect of tisagenlecleucel 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.

Tisagenlecleucel can also cause life-threatening nerve problems. Tell your caregivers or seek emergency medical attention if you have problems with speech, problems with thinking or memory, confusion, or a seizure.

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

Tisagenlecleucel 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 tisagenlecleucel. Because it will take time to process your blood cells into tisagenlecleucel, you will not receive the medicine on the same day your blood cells are drawn.

About 2 to 14 days before tisagenlecleucel is given, you will be pre-treated with chemotherapy to help prepare your body for tisagenlecleucel.

Just before you receive tisagenlecleucel, you will be given other medications to help prevent serious side effects or allergic reaction.

Once your body is ready to receive tisagenlecleucel, your care providers will inject the medicine into a vein through an IV.

For at least 4 weeks, plan to stay near the hospital or clinic where you received tisagenlecleucel. Avoid being so far away that it takes you longer than 2 hours to travel back to the hospital.

Serious and sometimes fatal infections may develop after the injection. Call your doctor right away if you have fever, chills, easy bruising, unusual bleeding, or other signs of infection.

tisagenlecleucel can cause you to have a false positive screening test for HIV (human immunodeficiency virus). Tell any doctor who treats you that you are using tisagenlecleucel.

Using tisagenlecleucel may increase your risk of developing other types of cancer, or causing your leukemia to come back. Your doctor will need to check your progress for the rest of your life.

If you have ever had hepatitis B, tisagenlecleucel can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

Tell your doctor if you have ever had:

• hepatitis B or C;

• HIV (human immunodeficiency virus); or

• if you have received a vaccine in the past 2 weeks.

Women may need pregnancy testing before receiving this medicine. You may also need to use birth control to prevent pregnancy during and shortly after treatment with tisagenlecleucel and chemotherapy.

If you receive tisagenlecleucel during pregnancy, your baby's blood may need to be tested after it is born. This is to evaluate any effects the medicine may have had on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Call your doctor for instructions if you miss any of your chemotherapy treatment, or if you miss a dose of your medications to prevent side effects of tisagenlecleucel.

Since tisagenlecleucel 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 tisagenlecleucel.

Ask your doctor before you receive a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Do not donate blood, an organ, or any tissues or cells from your own body.

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

A serious side effect of tisagenlecleucel is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, body aches, vomiting, diarrhea, or feeling light-headed. Your caregivers will have medication available to quickly treat CRS if it occurs.

Also tell your caregivers or seek emergency medical attention if you have signs of life-threatening nerve problems: problems with speech, problems with thinking or memory, confusion, or a seizure.

Also call your doctor at once if you have:

• headaches, unusual tiredness;

• tremors, anxiety, agitation;

• unusual thoughts or behavior;

• trouble speaking or understanding what is said to you; or

• signs of infection--fever, chills, flu symptoms, mouth sores, skin sores, easy bruising or bleeding, cough, trouble breathing.

Common side effects of tisagenlecleucel may include:

• nausea, vomiting, diarrhea, loss of appetite;

• fever;

• headache, confusion, feeling tired;

• bleeding; or

• fast heartbeats.

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 tisagenlecleucel, 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.