Generic Name: tisagenlecleucel (TIS a JEN lek LOO sel)
Brand Name: Kymriah
What is tisagenlecleucel?
Tisagenlecleucel is an immunotherapy medicine used to treat a certain type of acute lymphoblastic leukemia in people who are up to 25 years old. This medicine is given after other treatments have failed.
Tisagenlecleucel is made from your own white blood cells, removed from a small amount of blood drawn from your body.
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 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.
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.
Before taking this medicine
To make sure tisagenlecleucel is safe for you, tell your doctor if you have ever had:
hepatitis B or C;
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.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.
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 is not known whether tisagenlecleucel passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.
How is tisagenlecleucel given?
Your care providers will use an intravenous (IV) needle to draw your blood for collecting the white blood cells. The cells are then frozen and sent to a laboratory where they are made into tisagenlecleucel. This could take 3-4 weeks.
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.
This medicine 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.
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.
What happens if I miss a dose?
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.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid after receiving tisagenlecleucel?
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.
Do not donate blood, an organ, or any tissues or cells from your own body.
Do not receive a "live" vaccine while using tisagenlecleucel, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Tisagenlecleucel side effects
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;
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 may include:
nausea, vomiting, diarrhea, loss of appetite;
headache, confusion, feeling tired;
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.
See also: Side effects (in more detail)
What other drugs will affect tisagenlecleucel?
Other drugs may interact with 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.
Where can I get more information?
- Your pharmacist can provide more information about tisagenlecleucel.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2012 Cerner Multum, Inc. Version: 1.02.
Date modified: January 03, 2018
Last reviewed: November 01, 2017