KYMRIAH- tisagenlecleucel injection, suspension 
Novartis Pharmaceuticals Corporation

----------

This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: May 2018
MEDICATION GUIDE
KYMRIAHTM (pronounced KIM-RYE-AH)
(tisagenlecleucel)
Read this Medication Guide before you start your KYMRIAH treatment. The more you know about your treatment, the more active you can be in your care. Talk with your healthcare provider if you have questions about your health condition or treatment. Reading this Medication Guide does not take the place of talking with your healthcare provider about your treatment.
What is the most important information I should know about KYMRIAH?

KYMRIAH may cause side effects that are severe or life-threatening. Call your healthcare 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
  • confusion
  • severe nausea, vomiting, diarrhea
  • severe 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 healthcare providers may give you other medicines to treat your side effects.

What is KYMRIAH?

KYMRIAH is made from your own white blood cells and is a prescription cancer treatment used in patients up to 25 years old who have acute lymphoblastic leukemia (ALL) that is either relapsing (went into remission, then came back) or refractory (did not go into remission after receiving other leukemia treatments). It is also used in patients with non- Hodgkin lymphoma that has relapsed or is refractory after having at least two other kinds of treatment.
How will I get KYMRIAH?

Since KYMRIAH is made from your own white blood cells, your healthcare 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 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 healthcare provider may give you chemotherapy for a few days to prepare your body.

When your body is ready, your healthcare 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
  • severe muscle or joint pain
  • very low blood pressure 
  • dizziness/lightheadedness
  • headache
KYMRIAH can increase the risk of life-threatening infections that may lead to death. Tell your healthcare 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 healthcare provider will test your blood to check for this. Tell your healthcare 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.

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 healthcare provider about any concerns. You can ask your healthcare provider for information about KYMRIAH that is written for healthcare professionals.

For more information, go to KYMRIAH.com or call 1-844-NVS-CART (1-844-687-2278).

Manufactured and Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936.

© Novartis

T2018-62

Revised: 6/2019
Novartis Pharmaceuticals Corporation