Understanding Side Effects
KYMRIAH
What side effects may I experience with KYMRIAH?
There are side effects you may experience with KYMRIAH® (tisagenlecleucel) therapy. Your treatment team knows what to expect and is prepared to help manage these side effects.
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:
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
Cytokine Release Syndrome
Cytokine release syndrome (CRS) is a common and expected side effect that happens when the immune system is highly activated, as with KYMRIAH therapy. It can range from mild symptoms like fever and muscle pains, to severe symptoms like low blood pressure and breathing trouble.
Your treatment team is prepared to manage CRS. Mild-to-moderate CRS may require hospitalization, antibiotics, and pain medications. Severe CRS may require medication, a stay in the intensive care unit (ICU), or breathing support.
Cytokine release syndrome (CRS), a side effect that can happen when the immune system is highly activated.
Neurological Events
KYMRIAH may also have effects on the brain. You may feel very 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 3 weeks. They may go away on their own, but be sure to tell your doctor right away if you experience any neurological signs or symptoms.
Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS)
Be sure to discuss with your health care provider the possibility of developing this life-threatening condition, and thereafter, your doctor will monitor you for the possibility of developing HLH/MAS.
Allergic Reactions
Serious allergic reactions, including anaphylaxis, which is a life-threatening allergic reaction, may occur after you receive KYMRIAH. Some signs and symptoms may include difficulty breathing, very low blood pressure, dizziness, swelling under skin, rash, nausea, and vomiting. You should seek emergency medical treatment right away if you have an allergic reaction.
Serious Infections
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.
Prolonged Low Blood Cell Counts (Cytopenia)
KYMRIAH may cause a condition called cytopenia. This is when you have low levels of one or more types of blood cells. Your treatment team will do blood tests to check all of your blood cell counts after treatment with KYMRIAH. Cytopenia that lasts a long time (is prolonged) may increase your risk of infection. Cytopenia will be monitored, and your treatment team is prepared to manage it. 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. B cells defend your body by producing antibodies. Antibodies bind to invaders so other immune cells can destroy them.
After KYMRIAH, you may have fewer normal B cells and, therefore, fewer antibodies. A low level of antibodies in your blood is a condition called hypogammaglobulinemia (HY-po-GAM-muh-GLOB-u-lin-EE-mee-uh). If untreated, a low antibody level may increase your risk for infections. Your treatment team can manage this with antibody replacement medications (for example, IVIG infusions). Tell your doctor right away if you develop signs or symptoms of an infection.
Antibodies, proteins made by your B cells that help to protect the body against infection; B cells, along with other cells, make up your body’s immune system. They defend the body by producing antibodies; IVIG infusions, infusions that give you antibodies to help fight infections and make your immune system stronger.
Secondary Cancers
KYMRIAH may increase your risk of getting cancers, including certain types of blood cancers. Your health care provider should monitor you for this.
Effects on Ability to Drive and Use Machines
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.
Common side effects
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
These are not all the possible side effects of KYMRIAH treatment. Talk to your treatment team about other possible side effects and medical advice about side effects. 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.
How will I feel after KYMRIAH?
After you get your new KYMRIAH CAR-T cells, you may feel bad in different ways, including feeling sick, tired, or very warm. Sometimes these feelings will go away on their own, but your doctor is here to help you if they don't.
What is the KYMRIAH REMS Program?
A risk evaluation and mitigation strategy (REMS) is a program to manage known or potential serious risks associated with a drug product and is required by the FDA to ensure that the benefits of the drug outweigh its risks. Because of the risk of CRS and neurological toxicities, the FDA has required a REMS for KYMRIAH. KYMRIAH is only available through select treatment centers participating in the KYMRIAH REMS Program.
Visit www.KYMRIAH-REMS.com to learn more about the program.
