Tisagenlecleucel (tis-a-jen-lek-LOO-sel)

Treats acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma.

Brand Name(s):

Kymriah

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the IV tube should remain in place for less than an hour.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive a live vaccine for at least 6 weeks before the start of treatment, during treatment, and until recovery following the last cycle of this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have lung or breathing problems, heart problems, low blood pressure, blood problems, a weak immune system, any type of infection, or a history of infections (including hepatitis B).
• This medicine may cause the following problems:
  • Cytokine release syndrome, which may be life-threatening
  • Nerve problems
  • Serious infections
  • Hypogammaglobulinemia (immune system problem)
  • Increased risk for other cancer
• This medicine may cause dizziness, confusion, seizures, or decreased alertness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you for at least 8 weeks after treatment.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, fast, slow, or uneven heartbeat
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, headache, cough, sore throat, body aches
• Lightheadedness, dizziness, fainting
• Muscle or bone pain
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Problems with balance, walking, or speaking, confusion
• Rapid weight gain, swelling in your hands, ankles, or feet
• Seizures
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Nausea, vomiting, diarrhea, stomach pain
• Pain, itching, burning, swelling, or a lump under your skin where the needle was placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088