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 the time may vary.
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 one 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. Call your health care provider or get emergency help right away if you get any of the following:
It is important that you tell your health care providers that you have received KYMRIAH. Your health care providers may give you other medicines to treat your side effects.
The most common side effects of KYMRIAH are:
KYMRIAH can increase the risk of life-threatening infections that may lead to death. Tell your health care provider right away if you develop fever, chills, or any signs or symptoms of an infection.
KYMRIAH can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets). After treatment, your health care provider will test your blood to check for this. Tell your health care provider right away if you get a fever, are feeling tired, or have bruising or bleeding.
Having KYMRIAH in your blood may cause a false-positive HIV test result by some commercial tests.
These are not all the possible side effects of KYMRIAH. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.