WARNING

While Kymriah (tisagenlecleucel) can be effective in treating certain types of cancer, it is associated with several risks and potential side effects. It’s important to note that the risks and side effects can vary from person to person. Here are some of the key risks and side effects associated with Kymriah:

• Cytokine Release Syndrome (CRS): This is a common and potentially serious side effect of Kymriah treatment. It occurs when the modified T cells are activated and release a large amount of cytokines, which can cause flu-like symptoms such as fever, chills, nausea, fatigue, headache, and muscle pain. In severe cases, CRS can lead to low blood pressure, difficulty breathing, and organ damage.
• Neurological Toxicities: Another potential side effect of Kymriah treatment is neurologic toxicity, which can cause confusion, difficulty speaking or understanding speech, seizures, tremors, and other neurologic symptoms. These effects can be temporary or long-lasting.
• Risk of Infections: Kymriah can lower the number of healthy white blood cells, including infection-fighting cells. This increases the risk of infections, which can be severe or even life-threatening. Patients are closely monitored for signs of infection during and after treatment.
• Prolonged Cytopenias: Some patients may experience a decrease in blood cell counts, including red blood cells, white blood cells, and platelets. This can lead to anemia, increased risk of bleeding, and increased susceptibility to infections.
• Risk of Secondary Cancers: There is a small risk of developing secondary cancers, including leukemia, after receiving Kymriah treatment. Regular monitoring for the development of secondary cancers is recommended.

It is important to discuss these risks and potential side effects with your healthcare provider before starting Kymriah treatment. They will carefully evaluate your individual situation and monitor you closely throughout the treatment process to manage and mitigate these risks.

Why is this medication prescribed?

Kymriah (tisagenlecleucel) is a prescription medication used for the treatment of certain types of cancer. Specifically, it is approved for use in children and young adults up to 25 years old with acute lymphoblastic leukemia (ALL) that has relapsed or is refractory (did not respond to initial treatment), as well as for adult patients with certain types of advanced lymphomas.

Kymriah is classified as a chimeric antigen receptor (CAR) T-cell therapy. It works by modifying a patient’s own white blood cells, specifically T cells, to recognize and attack cancer cells. The treatment involves a process where a patient’s T cells are collected, genetically modified in a laboratory to express a CAR that targets a specific protein found on cancer cells, and then reinfused back into the patient. These modified T cells can then locate and destroy cancer cells in the body.

How should this medicine be used?

Kymriah (tisagenlecleucel) is a specialized therapy that is administered under the supervision of a healthcare professional in a certified treatment center. Here are the general steps involved in the use of Kymriah:

• Collection of T cells: Before starting Kymriah treatment, a patient’s own T cells are collected through a process called leukapheresis. This involves the extraction of blood from the patient, separation of T cells from the blood, and return of the remaining blood components back to the patient.
• Genetic modification: The collected T cells are sent to a laboratory where they are genetically modified to express a chimeric antigen receptor (CAR) that recognizes a specific protein found on cancer cells. This process typically takes a few weeks.
• Conditioning chemotherapy: Before receiving the modified T cells, the patient may undergo conditioning chemotherapy. This involves receiving chemotherapy drugs to help prepare the body for the infusion of the modified T cells. The specific chemotherapy regimen can vary depending on the type of cancer being treated.
• Infusion of modified T cells: Once the modified T cells are ready, they are infused back into the patient’s bloodstream. This infusion is typically done in a hospital setting and can take several hours. The healthcare team closely monitors the patient during and after the infusion for any adverse reactions.
• Monitoring and follow-up: After receiving Kymriah, patients are closely monitored for potential side effects and complications, including cytokine release syndrome (CRS) and neurologic toxicities. Regular follow-up visits and tests are conducted to assess the treatment’s effectiveness and manage any side effects.

It’s important to note that the specific treatment plan for Kymriah may vary depending on the individual patient’s condition and the treating healthcare provider’s judgment. The administration and monitoring process is highly specialized and requires expertise in CAR T-cell therapy. Therefore, it is crucial to seek treatment at a certified treatment center with experience in using Kymriah.

Other uses for this medicine

Kymriah (tisagenlecleucel) is primarily used for the treatment of certain types of cancer, specifically acute lymphoblastic leukemia (ALL) in children and young adults up to 25 years old and certain types of advanced lymphomas in adult patients. As of my knowledge cutoff in September 2021, these are the approved indications for Kymriah.

What special precautions should I follow?

Regarding special precautions, Kymriah is associated with significant risks and potential side effects. Here are some important precautions to consider:

• Certified Treatment Centers: Kymriah treatment is only available through certified treatment centers. These centers have the necessary expertise, infrastructure, and resources to handle the complex administration and management of Kymriah therapy.
• Monitoring: Patients who receive Kymriah require close monitoring during and after treatment for potential side effects, including cytokine release syndrome (CRS), neurologic toxicities, infections, and cytopenias. Regular follow-up visits and tests are conducted to assess the patient’s response to treatment and manage any complications.
• Patient Eligibility: Kymriah is typically prescribed to patients who have not responded to standard treatments or have relapsed after prior therapy. Eligibility for Kymriah treatment is determined by a healthcare professional based on various factors, including the patient’s diagnosis, disease stage, prior treatment history, and overall health.
• Potential Side Effects: Patients and healthcare providers should be aware of the potential side effects associated with Kymriah, such as CRS, neurologic toxicities, infections, and cytopenias. Prompt recognition and management of these side effects are crucial for patient safety.
• Long-Term Effects and Secondary Cancers: Due to the relatively recent introduction of Kymriah, the long-term effects of this therapy are still being studied. There is a small risk of developing secondary cancers, including leukemia, after receiving Kymriah. Regular monitoring for the development of secondary cancers is recommended.

It’s important to consult with a healthcare professional for personalized information and advice regarding the specific precautions and considerations related to Kymriah treatment.

What special dietary instructions should I follow?

Kymriah is a type of chimeric antigen receptor (CAR) T-cell therapy used in the treatment of certain types of cancer. It is a personalized treatment that involves modifying a patient’s own T-cells to target and destroy cancer cells. Since Kymriah is administered as an infusion, there are no specific dietary instructions associated with it.

What should I do if I forget a dose?

If you forget a dose of Kymriah, it’s essential to contact your healthcare provider immediately. They will be able to provide you with guidance on the next steps to take. It’s crucial to adhere to the recommended treatment schedule to optimize the effectiveness of Kymriah and ensure the best possible outcome. Therefore, if you miss a scheduled dose, it’s important to communicate with your healthcare team promptly.

What side effects can this medication cause?

Kymriah (tisagenlecleucel) can cause several side effects, some of which can be serious or potentially life-threatening. The specific side effects can vary from person to person, and not all patients will experience the same ones. Here are some of the common and potentially significant side effects associated with Kymriah:

• Cytokine Release Syndrome (CRS): CRS is a common side effect of Kymriah treatment and occurs when the modified T cells are activated and release cytokines into the body. Symptoms of CRS can range from mild to severe and may include fever, chills, nausea, headache, fatigue, muscle pain, low blood pressure, difficulty breathing, and organ dysfunction. Severe cases of CRS require prompt medical intervention.
• Neurological Toxicities: Neurological toxicities can occur following Kymriah treatment and may manifest as confusion, difficulty speaking or understanding speech, seizures, tremors, delirium, and other neurologic symptoms. These toxicities can be temporary or long-lasting and may require supportive care or treatment.
• Infections: Kymriah can lower the number of healthy white blood cells, including infection-fighting cells, increasing the risk of infections. Infections can range from mild to severe and may include bacterial, viral, or fungal infections. Prompt identification and treatment of infections are essential.
• Cytopenias: Kymriah may cause a decrease in blood cell counts, including red blood cells, white blood cells, and platelets. This can result in anemia, increased risk of bleeding, and increased susceptibility to infections. Blood counts are closely monitored, and transfusions or other supportive measures may be required.
• Febrile Neutropenia: Neutropenia is a condition characterized by low levels of neutrophils, a type of white blood cell that helps fight infections. Febrile neutropenia refers to the presence of fever along with neutropenia. It is an important complication of Kymriah treatment and requires immediate medical attention.
• Hypogammaglobulinemia: Kymriah can cause a decrease in immunoglobulins, which are antibodies that help the body fight infections. This can lead to a higher risk of infections and may require immunoglobulin replacement therapy.

It’s important to note that these side effects are not exhaustive, and other complications or adverse events may occur. It is essential to discuss the potential side effects of Kymriah with your healthcare provider, as they can provide you with more detailed and personalized information based on your specific situation.

What should I know about storage and disposal of this medication?

• Storage: Kymriah is typically stored by the healthcare provider or treatment center where you receive the therapy. It is stored under controlled conditions according to specific temperature requirements. The healthcare provider will ensure proper storage and handling of Kymriah to maintain its effectiveness and safety.
• Disposal: As Kymriah is administered in a healthcare facility, the disposal of any unused or expired Kymriah is the responsibility of the healthcare provider. They follow appropriate protocols and guidelines for the safe disposal of medical waste, including Kymriah-related materials.

In case of emergency/overdose

• Emergency: If you experience a medical emergency while receiving Kymriah, such as severe allergic reactions, difficulty breathing, or other life-threatening symptoms, immediately seek medical assistance by calling emergency services or going to the nearest emergency room. Inform the healthcare professionals about your Kymriah treatment and provide any relevant information.
• Overdose: Kymriah is administered under the supervision of healthcare professionals who carefully calculate and administer the appropriate dose. Therefore, the likelihood of an accidental overdose is minimal. If you have any concerns about the dosage or administration of Kymriah, discuss them with your healthcare provider.

What other information should I know?

• Follow-up and Monitoring: After receiving Kymriah, you will require regular follow-up visits and monitoring to assess your response to treatment, manage any side effects or complications, and monitor for long-term effects. It is important to attend these appointments and communicate any concerns or changes in your health to your healthcare provider.
• Precautions: It is crucial to adhere to any precautions provided by your healthcare provider regarding infections and other potential risks. These may include avoiding close contact with individuals who have infections, practicing good hygiene, and following specific guidelines for vaccinations.
• Clinical Trials and Research: Kymriah is an innovative therapy, and ongoing research and clinical trials are conducted to explore its potential uses in other types of cancer and conditions. Your healthcare provider may discuss the option of participating in clinical trials if appropriate.
• Supportive Care: Kymriah treatment may involve supportive care measures to manage side effects and optimize your overall well-being. This can include medications, transfusions, or other interventions as needed. It’s important to communicate with your healthcare provider about any symptoms or concerns you may have.

Remember, the information provided here is a general overview, and it’s important to consult with your healthcare provider for personalized guidance and detailed information about storage, disposal, emergency procedures, and any specific considerations related to your individual situation.