KYMRIAH® (tisagenlecleucel) may cause side effects that are severe or life-threatening. Call your health care provider or get emergency help right away if you get any of the following:
- difficulty breathing
- fever (100.4°F/38°C or higher)
- chills/shaking chills
- severe nausea, vomiting, diarrhea
- severe muscle or joint pain
- very low blood pressure
Go to What side effects may I experience with KYMRIAH? to learn what other signs and symptoms to look for.
KYMRIAH is a type of cutting-edge immunocellular therapy. This means that KYMRIAH harnesses the power of your own immune system to treat your cancer.
KYMRIAH reprograms your T cells, natural defenders that are a part of your immune system. T cells detect and destroy infected or cancerous cells by looking for certain antigens. Antigens are markers on cells that help your immune system identify normal cells from infected or cancerous cells. KYMRIAH helps your T cells recognize a certain antigen on your B cells called CD19. By reprogramming your T cells, KYMRIAH enhances their ability to detect and destroy B cells, including those that are cancerous.
Go to What is KYMRIAH? for more details.
- KYMRIAH is a treatment that comes from within you
- KYMRIAH is typically given as a single infusion
- KYMRIAH uses a short course (4 days) of chemotherapy to prepare your body for infusion
- KYMRIAH targets only your B cells rather than all of your body’s cells
Go to What is KYMRIAH? for more details.
In the past, one of the only options for children and young adults with relapsed or refractory B-cell ALL has been allogeneic stem cell transplant (SCT). This type of SCT requires a donor and may require complete remission status before the transplant can take place. About 1 in 4 patients cannot achieve complete remission in preparation for SCT.
Now there is KYMRIAH—a therapy option for children and young adults with relapsed or refractory B-cell ALL looking for a different way to try to treat their cancer. KYMRIAH is a treatment that comes from within you. KYMRIAH uses your own cells so it does not require a donor and there is no donor search period. You can also start KYMRIAH therapy even if you aren't in remission. To learn about the associated side effects of KYMRIAH, go to What side effects may I experience with KYMRIAH? for a full explanation.
Go to What is the process for getting KYMRIAH? for details on starting your KYMRIAH journey. Once you and your doctor decide KYMRIAH is right for you, you may get a referral to a KYMRIAH Treatment Center. Go to Find a KYMRIAH Treatment Center for a list of available treatment centers, or call KYMRIAH CARES™ at 1-844-4KYMRIAH (1-844-459-6742) to find out if there are additional KYMRIAH Treatment Centers closer to you.
Since KYMRIAH is made from your own cells, the process starts with you. You will first need to undergo cell collection, also known as leukapheresis (pronounced "loo-kuh-fuh-REE-sis"). Then your cells are sent to the Novartis manufacturing facility to reprogram them into cancer-fighting cells. Once your cells are ready, they are returned to you through a standard infusion. Go to What is the process for getting KYMRIAH? for more details.
KYMRIAH CARES offers assistance to eligible patients to help them gain access to KYMRIAH treatment. Patients with a KYMRIAH order may apply for support. Program eligibility criteria must be met to qualify to receive support. To determine eligibility, please work with your treatment center to submit a Service Request Form for Patient Support to KYMRIAH CARES. Once we have received the request, we will follow up with you and your physician to explain your benefit eligibility. For more information, or if you have more questions, please call KYMRIAH CARES at 1-844-4KYMRIAH (1-844-459-6742).
There are side effects you may experience with KYMRIAH therapy. Your treatment team knows what to expect and is prepared to help manage these side effects.
- Cytokine Release Syndrome
Cytokine release syndrome (CRS) is a common and expected side effect that happens when the immune system is highly activated, like with KYMRIAH therapy. It can range from mild symptoms like fever and muscle pains, to severe symptoms like low blood pressure and breathing trouble. Mild‑to‑moderate CRS may require hospitalization, antibiotics, and pain medications. Severe CRS may require medication, a stay in the intensive care unit (ICU), and breathing support.
- Neurological Events
KYMRIAH may have effects on the brain, causing you to feel confused, unaware, or agitated. More severe symptoms might affect your speech or cause hallucinations or seizures. In most cases, symptoms occur within 8 weeks of receiving KYMRIAH and resolve within 12 days. They may go away on their own, but be sure to tell your doctor right away if you experience any neurological signs or symptoms.
- Prolonged Low Blood Cell Counts (Cytopenia)
KYMRIAH may cause low levels of one or more types of blood cells or “cytopenia.” Cytopenia that lasts a long time (prolonged) may increase your risk of infection, but your treatment team will do blood tests to check all of your blood cell counts. Tell your doctor right away if you get a fever, are feeling tired, or have bruising or bleeding.
- Low Antibody Levels (Hypogammaglobulinemia)
Because KYMRIAH CAR-T cells are designed to detect and destroy your B cells, they will also attack the normal B cells in your body. Normal B cells produce antibodies, which protect you from infections. After KYMRIAH, you may have fewer B cells and, therefore, fewer antibodies. This condition is called hypogammaglobulinemia (hy-po-gam-muh-glob-u-lin-EEM-EE-uh). Your treatment team can manage your low antibody level with antibody-replacement medications, but tell your doctor right away if you develop signs or symptoms of an infection.
Note that this is not a complete list of side effects of KYMRIAH. See the Important Safety Information for a more detailed list of side effects. Go to Understanding Side Effects for a detailed explanation of potential side effects.
About a month after your KYMRIAH infusion, your treatment team will check your progress. Highly sensitive tests give a very precise measure of remission that may indicate to your treatment team how well KYMRIAH is working. Your treatment team will continue to monitor your progress after KYMRIAH.
After you receive KYMRIAH, do not drive, operate heavy machinery, or do other dangerous activities for 8 weeks. Do not donate blood, organs, tissues, or cells for transplantation.
You should plan to stay within 2 hours of your KYMRIAH Treatment Center for at least 4 weeks after receiving KYMRIAH.