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KYMRIAH IS NOW FDA APPROVED
KYMRIAH may cause side effects that are severe or life-threatening. Call your health care provider or get emergency help right away if you have any of the following:
- difficulty breathing
- fever (100.4°F/38°C or higher)
- chills/shaking chills
- confusion
- severe nausea, vomiting, diarrhea
- serious muscle or joint pain
- very low blood pressure
- dizziness/lightheadedness
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.
How will I get KYMRIAH?
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 3-4 weeks to make KYMRIAH, 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 healthcare provider will check to see if your treatment is working and help you with any side effects that occur.
What should I avoid after receiving KYMRIAH?
- Do not drive, operate heavy machinery, or do other dangerous things for 8 weeks after you get KYMRIAH because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, weakness, dizziness, and seizures.
- Do not donate blood, organs, tissues and cells for transplantation.
What are the possible or reasonably likely side effects of KYMRIAH?
The most common side effects of KYMRIAH are:
- difficulty breathing
- fever (100.4°F/38°C or higher)
- chills/shaking chills
- confusion
- severe nausea, vomiting, diarrhea
- serious muscle or joint pain
- very low blood pressure
- dizziness/lightheadedness
- 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 health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of KYMRIAH
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use KYMRIAH for a condition for which it was not prescribed. Talk to your health care provider about any concerns. You can ask your health care provider for information about KYMRIAH that is written for health care professionals. For more information, go to KYMRIAH.com or call 1-844-NVS-CART (1-844-687-2278).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the full Prescribing Information for KYMRIAH, including Boxed WARNING, and Medication Guide.
