For US residents only.
KYMRIAH® (tisagenlecleucel) is made from your own white blood cells and is a prescription cancer treatment used in patients with non-Hodgkin lymphoma that has relapsed or is refractory after having at least two other kinds of treatment.
Since KYMRIAH is made from your own white blood cells, your health care provider has to take some of your blood. This is called “leukapheresis.” It takes 3 to 6 hours and may need to be repeated. A tube (intravenous catheter) will be placed in your vein to collect your blood.
Your blood cells are frozen and sent to the manufacturing site to make KYMRIAH. It takes about 3 to 4 weeks from the time your cells are received at the manufacturing site and shipped back to your health care provider, but this timing, and success rates, can vary. Your treatment team can help guide you through the process.
Before you get KYMRIAH, your health care provider may give you chemotherapy for a few days to prepare your body.
When your body is ready, your health care provider will give you KYMRIAH through a tube (intravenous catheter) in your vein. This usually takes less than 1 hour.
You should plan to stay within 2 hours of the location where you received your treatment for at least 4 weeks after getting KYMRIAH. Your health care provider will check to see if your treatment is working and help you with any side effects that occur.
KYMRIAH may cause side effects that are severe or life-threatening, such as cytokine release syndrome (CRS) and neurological toxicities. Call your health care provider or get emergency help right away if you get any of the following signs and symptoms of:
You may be admitted to the hospital and treated with other medications if you have any of these side effects. If you are admitted to the hospital, tell the health care provider that you have received KYMRIAH.
Because of the risk of CRS and neurological toxicities, KYMRIAH is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS.
The most common side effects of KYMRIAH are:
These are not all the possible side effects of KYMRIAH. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.