Understanding KYMRIAH Side Effects

KYMRIAH CAR-T cell therapy safety considerations and side effects

How long does it take to recover after KYMRIAH treatment?

Recovery times will vary for each individual. You should plan to stay within 2 hours of your treatment center for at least 4 weeks after you have been given KYMRIAH (tisagenlecleucel). Your doctor will consider whether you need to stay at the hospital as an inpatient for the first 10 days after infusion. If receiving KYMRIAH as an outpatient, your doctor will recommend that you return to the hospital daily for at least 10 days. This is so your doctor can check if your treatment is working and help you if you have any side effects.

It’s a good idea to take someone with you to these appointments, such as a caregiver, family member or friend. They’ll help you remember to ask certain questions or write down the answers while you listen. They can also drive you to and from the appointment.

Are there any serious side effects I may experience with KYMRIAH?

KYMRIAH may cause side effects that are severe or life-threatening. Your treatment team is specially trained to monitor for and manage these potential side effects in people with relapsed/refractory (r/r) follicular lymphoma (FL). Most side effects happen in the first few weeks following infusion with KYMRIAH.


Call your health care provider or get emergency help right away if you get any of the following signs and symptoms of:


Cytokine release syndrome (CRS)

  • Difficulty breathing
  • Fever (100.4°F/38°C or higher)
  • Chills/shaking chills
  • Severe nausea, vomiting, diarrhea
  • Severe muscle or joint pain
  • Very low blood pressure
  • Dizziness/lightheadedness

Neurological toxicities

  • Altered or decreased consciousness
  • Delirium
  • Confusion
  • Agitation
  • Seizures
  • Difficulty speaking and understanding
  • Loss of balance


Cytokine Release Syndrome (CRS)

Cytokine release syndrome (CRS) is a condition where the immune system produces and releases an excessive amount of small proteins called cytokines into the blood. It is the most common and expected side effect of KYMRIAH, as well as other CAR-T therapies. Symptoms range from fever or low blood pressure to irregular or rapid heartbeat. CRS may be associated with liver, kidney, and heart dysfunction and bleeding disorders.


In clinical trials, most patients experienced CRS within 4 days after infusion. Your treatment team will check your progress after infusion. Members of your team are trained to recognize the symptoms of CRS and have specific medicines to treat it.


Neurological Problems

KYMRIAH may also cause neurological toxicities (affecting the central nervous system), making you feel confused, agitated, dizzy, or disoriented. More severe symptoms might affect your speech or consciousness or cause seizures. Be sure to tell your treatment team right away if you experience any neurological symptoms. You may be admitted to the hospital if you have any of these side effects.


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 your blood cell counts after treatment with KYMRIAH. Cytopenia that lasts a long time (several weeks) may increase your risk of infection. Your treatment team will monitor and manage cytopenia. Tell your doctor right away if you get a fever, are feeling tired, weak, or short of breath, or have unusual bruising or bleeding.


Low Antibody Levels (Hypogammaglobulinemia)

KYMRIAH CAR-T cells are designed to find and kill your body’s B cells. This means they will also attack the healthy B cells that protect your body by producing antibodies. Antibodies work by binding to intruders which helps other immune cells to destroy them.


After KYMRIAH, you may have fewer normal B cells, leading to low levels of antibodies in your blood. This condition is known as hypogammaglobulinemia (HY-po-GAMmuh-GLOB-u-lin-EEM-ee-uh). If left untreated, it can increase your risk of infections. However, your treatment team can manage it with antibody replacement medications like intravenous immunoglobulin (IVIG) infusions. Since hypogammaglobulinemia can last for a long time, you may need regular antibody replacements. If you show any signs of an infection, inform your doctor immediately.


Effects on Ability to Drive and Use Machines

Do not drive or operate heavy or potentially dangerous machinery 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

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, weak, or short of breath, or have bruising or bleeding.


Having KYMRIAH in your blood may cause a false-positive HIV test result by some commercial tests.


Please note that these are not all the possible side effects of KYMRIAH treatment. Talk to your treatment team about other possible side effects and how to manage them. 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 for more information or to submit a report.

Illustration of a man and woman embracing


You can help after the infusion by watching for side effects. KYMRIAH can be given in an inpatient (stay in the center) or outpatient (leave center after infusion) setting. Before leaving the treatment center, your loved one’s treatment team will give you a list of potential side effects to watch for, as well as instructions for what to do if they happen.

KYMRIAH is only available at select treatment centers. These centers have been specially certified in how to manage the risks of cytokine release syndrome and neurological toxicities. This is why you and the person you care for will need to stay within 2 hours of the treatment center for at least 4 weeks after receiving KYMRIAH. Visit the Caregiver Resources page to find information and resources to help with your loved one’s treatment journey.

What is the KYMRIAH Risk Evaluation and Mitigation Strategy (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 cytokine release syndrome 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.

The KYMRIAH REMS program patient wallet card

When you join the KYMRIAH REMS program, you will receive a wallet card either before or during a KYMRIAH infusion. Remember to keep the card with you at all times once it's completed.

An image of the KYMRIAH Risk Evaluation and Mitigation Strategy (REMS) program patient wallet card

Visit www.KYMRIAH-REMS.com to learn more about the program or to download a replacement card if needed.