WARNING

Tisagenlecleucel is a type of immunotherapy known as CAR-T cell therapy. It’s used to treat certain types of cancers, particularly some types of leukemia and lymphoma. Like any medical treatment, it carries risks, including:

• Cytokine release syndrome (CRS): This is a common and potentially serious side effect of CAR-T cell therapy. It occurs when the immune cells activated by the treatment release proteins called cytokines, causing symptoms ranging from fever and flu-like symptoms to potentially life-threatening complications like low blood pressure and organ dysfunction.
• Neurological toxicity: Some patients may experience neurologic side effects, ranging from mild confusion and headaches to more severe issues like seizures or difficulty speaking.
• Infections: CAR-T cell therapy can weaken the immune system, making patients more susceptible to infections. Infections can be serious or life-threatening.
• Hypogammaglobulinemia: This is a condition where there are low levels of certain antibodies in the blood, which can increase the risk of infections.
• Tumor Lysis Syndrome (TLS): This occurs when cancer cells are destroyed rapidly, releasing their contents into the bloodstream faster than the body can eliminate them. This can lead to metabolic imbalances and kidney problems.
• Long-term side effects: Some patients may experience long-term side effects from CAR-T cell therapy, though the extent and severity vary widely. These may include issues like chronic fatigue, organ damage, or the development of secondary cancers.

It’s important for patients considering CAR-T cell therapy to discuss these risks thoroughly with their healthcare team and weigh them against the potential benefits of the treatment. Close monitoring during and after treatment is essential to manage any complications that may arise.

Why is this medication prescribed?

Tisagenlecleucel injection, marketed under the brand name Kymriah, is prescribed for the treatment of certain types of cancer, specifically:

• Acute Lymphoblastic Leukemia (ALL): Tisagenlecleucel is used in pediatric and young adult patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
• Diffuse Large B-Cell Lymphoma (DLBCL): It is also indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Tisagenlecleucel is a form of immunotherapy known as CAR-T cell therapy. It involves collecting a patient’s own T cells, genetically modifying them to express a chimeric antigen receptor (CAR) that targets cancer cells, and then infusing them back into the patient. This process enhances the immune system’s ability to recognize and destroy cancer cells.

How should this medicine be used?

The administration of Tisagenlecleucel is highly specialized and should only be performed by healthcare providers experienced in the management of patients receiving immunotherapy and in a certified healthcare facility. The general process involves the following steps:

• Preparation: Before receiving Tisagenlecleucel, patients may undergo various tests and evaluations to assess their eligibility for treatment and to prepare for potential side effects.
• Collection of T cells: A patient’s T cells are collected through a process called leukapheresis. This involves removing blood from the patient, separating out the T cells, and then returning the remaining blood components to the patient.
• Genetic modification: The collected T cells are sent to a laboratory where they are genetically modified to express the CAR that targets cancer cells.
• Treatment: Once the modified T cells are ready, the patient receives conditioning chemotherapy to prepare their immune system for the infusion of the CAR-T cells.
• Infusion: The modified T cells, now engineered to target and attack cancer cells, are infused back into the patient via intravenous (IV) infusion.
• Monitoring and management: Patients are closely monitored for potential side effects, such as cytokine release syndrome (CRS) and neurologic toxicity, which may require medical intervention.

Due to the complexity and potential risks associated with Tisagenlecleucel therapy, it’s crucial for patients to receive treatment from healthcare providers experienced in CAR-T cell therapy and to follow their instructions closely throughout the treatment process.

Other uses for this medicine

Tisagenlecleucel injection, also known as Kymriah, is primarily indicated for the treatment of certain types of cancer, specifically B-cell precursor acute lymphoblastic leukemia (ALL) in pediatric and young adult patients, as well as relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adult patients. However, research is ongoing to explore its potential use in other types of cancer and medical conditions. It’s essential to consult with healthcare professionals for the most up-to-date information on its uses and any ongoing clinical trials.

What special precautions should I follow?

As for special precautions to follow when receiving Tisagenlecleucel injection, here are some key points:

• Certified Healthcare Facility: Tisagenlecleucel injection should only be administered by healthcare providers who are experienced in the management of patients receiving immunotherapy and in facilities certified to administer this treatment.
• Patient Evaluation: Prior to treatment, patients undergo thorough evaluation to assess their eligibility for Tisagenlecleucel therapy. This evaluation may include tests to assess the severity of the disease, overall health status, and potential risks associated with the treatment.
• Monitoring for Side Effects: Patients receiving Tisagenlecleucel injection require close monitoring for potential side effects, including cytokine release syndrome (CRS) and neurologic toxicity. Monitoring typically occurs during and after treatment and may involve frequent assessments of vital signs, blood tests, and evaluation of symptoms.
• Risk Management and Management of Side Effects: Healthcare providers will implement strategies to manage and mitigate potential side effects of Tisagenlecleucel therapy, such as providing supportive care, administering medications to control symptoms, and, if necessary, initiating interventions to address severe adverse reactions.
• Infection Control: Due to the potential for immunosuppression following Tisagenlecleucel treatment, patients are at increased risk of infections. Healthcare providers may recommend precautions to minimize the risk of infection, such as avoiding contact with individuals who are sick, practicing good hand hygiene, and following specific guidelines for infection prevention.
• Long-Term Monitoring: Patients receiving Tisagenlecleucel injection require long-term monitoring to assess treatment response, detect any potential recurrence of cancer, and evaluate for the development of long-term side effects.

It’s crucial for patients to communicate openly with their healthcare providers about any concerns or questions regarding Tisagenlecleucel therapy and to adhere to their healthcare team’s recommendations throughout the treatment process.

What special dietary instructions should I follow?

There aren’t specific dietary instructions associated with Tisagenlecleucel injection. However, it’s essential to maintain a balanced and nutritious diet to support your overall health and immune function during and after treatment. Eating a variety of fruits, vegetables, whole grains, lean proteins, and staying hydrated is generally recommended. If you have specific dietary concerns or restrictions, discuss them with your healthcare provider or a registered dietitian.

What should I do if I forget a dose?

Since Tisagenlecleucel is administered as a single infusion, there’s no concern about missing a dose in the traditional sense. However, if you have any concerns or questions about your treatment schedule or any aspect of your care, it’s crucial to communicate with your healthcare provider promptly. They can provide guidance and address any issues or uncertainties you may have.

What side effects can this medication cause?

Tisagenlecleucel injection, like any medication or treatment, can cause side effects. Some of the potential side effects associated with Tisagenlecleucel therapy include:

• Cytokine Release Syndrome (CRS): CRS is a common side effect of CAR-T cell therapy, including Tisagenlecleucel. It occurs when the immune cells activated by the treatment release cytokines into the bloodstream, leading to symptoms ranging from mild flu-like symptoms (fever, chills, fatigue) to more severe complications such as low blood pressure, difficulty breathing, and organ dysfunction.
• Neurologic Toxicity: Some patients may experience neurologic side effects following Tisagenlecleucel treatment, such as confusion, headache, delirium, tremor, seizures, or difficulty speaking. These symptoms can vary in severity and may require medical intervention.
• Cytopenias: Tisagenlecleucel therapy may lead to a decrease in blood cell counts, including white blood cells, red blood cells, and platelets, which can increase the risk of infections, anemia, and bleeding.
• Infections: Due to the potential for immunosuppression following Tisagenlecleucel treatment, patients may be at increased risk of infections, including bacterial, viral, and fungal infections. Prompt identification and management of infections are essential.
• Hypogammaglobulinemia: Tisagenlecleucel therapy can lead to decreased levels of certain antibodies in the blood, which may increase the risk of infections.
• Tumor Lysis Syndrome (TLS): TLS can occur when cancer cells are destroyed rapidly, leading to the release of their contents into the bloodstream. This can result in metabolic imbalances, kidney problems, and other complications.
• Secondary Cancers: There is a risk of developing secondary cancers following Tisagenlecleucel therapy, although this risk appears to be low.
• Other Side Effects: Other potential side effects may include fatigue, nausea, vomiting, diarrhea, muscle pain, and joint pain.

It’s important to note that the severity and frequency of side effects can vary from person to person. Patients receiving Tisagenlecleucel therapy require close monitoring during and after treatment to promptly identify and manage any side effects that may occur. If you experience any concerning symptoms or side effects, it’s crucial to notify your healthcare provider immediately.

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

Storage and Disposal:

• Storage: Tisagenlecleucel injection is typically stored under specific conditions by healthcare professionals in certified healthcare facilities. Patients do not typically store this medication at home.
• Disposal: Since Tisagenlecleucel is administered as a single infusion by healthcare professionals, patients do not need to worry about disposal. Any unused portions or materials associated with the infusion process are handled and disposed of by healthcare providers according to medical waste management guidelines.

In case of emergency/overdose

In the event of an emergency or overdose related to Tisagenlecleucel injection, it’s essential to seek immediate medical attention by contacting your healthcare provider, going to the nearest emergency room, or calling emergency services (such as 911 in the United States). Healthcare professionals are trained to manage emergencies and can provide appropriate treatment and support as needed.

What other information should I know?

• Follow-Up Care: After receiving Tisagenlecleucel therapy, patients typically require ongoing follow-up care with their healthcare providers for monitoring of treatment response, potential side effects, and overall health status.
• Patient Education: Patients and caregivers should receive thorough education and instructions from healthcare providers regarding Tisagenlecleucel therapy, including potential side effects, signs of complications, and steps to take in case of emergencies.
• Supportive Care: Patients receiving Tisagenlecleucel therapy may require supportive care to manage potential side effects, such as cytokine release syndrome (CRS) or neurologic toxicity. Healthcare providers will provide guidance on supportive measures, medications, and interventions as needed.
• Monitoring: Regular monitoring is essential during and after Tisagenlecleucel therapy to assess treatment response, detect any potential complications, and ensure overall well-being.
• Communication: Open communication with healthcare providers is crucial throughout the treatment process. Patients and caregivers should feel comfortable discussing any concerns, questions, or changes in symptoms with their healthcare team.

It’s important to adhere to healthcare provider instructions and recommendations regarding Tisagenlecleucel therapy and to seek prompt medical attention for any concerns or emergencies.