WARNING

Brexucabtagene autoleucel, also known as CAR-T therapy, is a groundbreaking treatment for certain types of cancer, particularly certain types of lymphoma and leukemia. While it can be highly effective, there are risks associated with this treatment:

• Cytokine Release Syndrome (CRS): This is a common side effect where the immune cells activated by the therapy release cytokines, causing symptoms ranging from fever and flu-like symptoms to more severe complications like low blood pressure and organ dysfunction.
• Neurological Toxicities: Some patients may experience neurologic side effects, such as confusion, delirium, seizures, or difficulty speaking or understanding speech.
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): This is a condition characterized by neurological symptoms that can range from mild to severe and can be life-threatening if not managed promptly.
• Infections: The therapy can suppress the immune system, leaving patients vulnerable to infections, which can be serious or life-threatening.
• Hypogammaglobulinemia: This is a condition where there is a decrease in antibodies in the blood, which can increase the risk of infections.
• Hematologic Toxicities: These include low blood cell counts, which can lead to anemia, thrombocytopenia, or neutropenia, increasing the risk of bleeding or infection.
• Tumor Lysis Syndrome (TLS): This occurs when cancer cells break down rapidly, releasing their contents into the bloodstream, which can overwhelm the body’s ability to clear these substances, leading to electrolyte imbalances and kidney problems.
• Secondary Malignancies: There is a risk of developing other cancers as a result of the treatment.

It’s important for patients considering CAR-T therapy to discuss these risks thoroughly with their healthcare team and weigh them against the potential benefits of the treatment. Close monitoring and management of side effects are essential for maximizing the benefits and minimizing the risks of this therapy.

Why is this medication prescribed?

Brexucabtagene autoleucel injection, commonly known by its brand name Tecartus, is prescribed for the treatment of certain types of lymphoma, particularly relapsed or refractory mantle cell lymphoma (MCL) in adult patients. MCL is a subtype of non-Hodgkin lymphoma, a cancer of the lymphatic system.

Brexucabtagene autoleucel is a form of immunotherapy called CAR T-cell therapy. It involves modifying a patient’s own T cells, a type of white blood cell, to recognize and attack cancer cells that express a specific protein called CD19.

This treatment is typically recommended when other treatments, such as chemotherapy or stem cell transplant, have not been successful or have stopped working. It offers a new approach to treating lymphoma by harnessing the power of the immune system to target and destroy cancer cells.

How should this medicine be used?

Brexucabtagene autoleucel injection, commonly referred to as CAR-T therapy, is a specialized treatment for certain types of cancer, typically lymphoma and leukemia. Its usage involves a precise process:

• Patient Evaluation: Patients are thoroughly assessed by their healthcare team to determine if they are suitable candidates for CAR-T therapy. This evaluation includes factors such as the type and stage of cancer, previous treatments, overall health, and organ function.
• Cell Collection: A procedure called leukapheresis is performed to collect the patient’s own T cells, a type of white blood cell crucial for immune function. These cells are then transported to a specialized laboratory.
• Genetic Modification: In the laboratory, the collected T cells undergo genetic modification to equip them with chimeric antigen receptors (CARs). These receptors enable the T cells to recognize and attack cancer cells more effectively.
• Cell Expansion: The genetically modified T cells are cultured and expanded in the laboratory to increase their numbers. This step ensures that a sufficient quantity of CAR-T cells is available for treatment.
• Preparatory Conditioning: Before CAR-T infusion, patients may undergo conditioning chemotherapy to suppress their existing immune system and create a favorable environment for the modified T cells to proliferate and function optimally.
• CAR-T Infusion: The expanded and modified T cells, now known as CAR-T cells, are infused back into the patient’s bloodstream. This infusion is typically a one-time procedure administered in a healthcare facility under close medical supervision.
• Monitoring and Support: Following CAR-T infusion, patients are closely monitored for potential side effects, such as cytokine release syndrome (CRS) and neurologic toxicities. Supportive care measures, including medication and symptom management, are provided as needed to ensure patient safety and comfort.
• Long-term Follow-up: Patients undergo regular follow-up appointments with their healthcare team to assess treatment response, monitor for disease recurrence, and manage any long-term effects or complications associated with CAR-T therapy.

The precise administration and management of CAR-T therapy require specialized expertise and resources available in designated treatment centers experienced in CAR-T treatments. It’s crucial for patients to adhere to their healthcare team’s guidance and attend all scheduled appointments to optimize treatment outcomes and ensure patient well-being.

Other uses for this medicine

Brexucabtagene autoleucel injection, commonly known as CAR-T therapy, is primarily used for the treatment of specific types of cancer, particularly certain types of lymphoma and leukemia. However, research is ongoing to explore its potential use in other types of cancer and medical conditions.

What special precautions should I follow?

Regarding special precautions for brexucabtagene autoleucel injection, it’s essential to note the following:

• Patient Selection: CAR-T therapy is typically reserved for patients who have not responded to standard treatments or whose cancer has relapsed after previous therapies. Patients undergo comprehensive evaluations to determine if they are suitable candidates for this specialized treatment.
• Treatment Setting: CAR-T therapy is administered in specialized healthcare facilities equipped with expertise and resources for managing potential side effects and complications associated with the treatment. Patients should receive treatment only from healthcare providers experienced in CAR-T therapy.
• Pre-Treatment Evaluation: Before undergoing CAR-T therapy, patients undergo thorough medical evaluations to assess their overall health status, organ function, and risk factors for potential complications. This evaluation helps healthcare providers determine the appropriateness of CAR-T therapy and plan individualized treatment approaches.
• Side Effect Management: CAR-T therapy can cause significant side effects, including cytokine release syndrome (CRS) and neurologic toxicities. Healthcare providers closely monitor patients for signs of these side effects and provide prompt intervention and supportive care as needed to manage symptoms and minimize risks.
• Infection Prevention: Due to the immunosuppressive effects of CAR-T therapy, patients are at increased risk of infections. Healthcare providers may recommend prophylactic measures, such as vaccinations and antimicrobial medications, to reduce the risk of infections before and after CAR-T infusion.
• Long-Term Monitoring: Patients receiving CAR-T therapy require long-term follow-up care to monitor treatment response, detect disease recurrence, and manage any long-term effects or complications. Regular follow-up appointments with healthcare providers are essential for optimizing treatment outcomes and ensuring patient well-being.
• Patient Education: Patients and their caregivers should receive comprehensive education about CAR-T therapy, including its purpose, potential benefits, and risks. It’s important for patients to understand the importance of adhering to treatment protocols, attending follow-up appointments, and promptly reporting any concerning symptoms to their healthcare team.

By following these special precautions and working closely with their healthcare providers, patients undergoing brexucabtagene autoleucel injection can optimize treatment outcomes and minimize risks associated with this advanced therapy.

What special dietary instructions should I follow?

• Hydration: Drink plenty of fluids, unless otherwise instructed by your healthcare provider. Proper hydration can help prevent dehydration, especially during episodes of fever or cytokine release syndrome (CRS).
• Nutritious Diet: Maintain a balanced and nutritious diet to support your overall health and immune function. Consult with a registered dietitian if you have specific dietary concerns or restrictions.
• Avoid Certain Foods: Your healthcare provider may recommend avoiding certain foods or beverages that may increase the risk of infections or exacerbate side effects. Follow any dietary restrictions provided by your healthcare team.

What should I do if I forget a dose?

• Brexucabtagene autoleucel injection is typically administered as a one-time infusion and does not involve daily dosing like traditional medications. However, if you have concerns about missed appointments or doses, contact your healthcare provider immediately for guidance.
• It’s essential to adhere to the recommended treatment schedule and attend all scheduled appointments to ensure the effectiveness of CAR-T therapy and minimize the risk of disease progression.

What side effects can this medication cause?

Brexucabtagene autoleucel injection, also known as CAR-T therapy, can cause a range of side effects, some of which can be severe. Common side effects include:

• Cytokine Release Syndrome (CRS): CRS is a systemic inflammatory response caused by the activation and proliferation of immune cells. Symptoms can range from mild (fever, chills, headache) to severe (low blood pressure, difficulty breathing, organ dysfunction). CRS can be life-threatening if not promptly managed.
• Neurologic Toxicities: Some patients may experience neurologic side effects, such as confusion, delirium, seizures, tremors, or difficulty speaking or understanding speech. These symptoms can vary in severity and may require medical intervention.
• Infections: CAR-T therapy can suppress the immune system, increasing the risk of infections. Patients may develop bacterial, viral, or fungal infections, which can be serious or life-threatening.
• Hematologic Toxicities: CAR-T therapy can cause changes in blood cell counts, including low red blood cells (anemia), low platelets (thrombocytopenia), and low white blood cells (neutropenia). These changes can increase the risk of bleeding, infections, and other complications.
• Tumor Lysis Syndrome (TLS): TLS occurs when cancer cells break down rapidly, releasing their contents into the bloodstream. This can lead to electrolyte imbalances, kidney problems, and other complications.
• Hypogammaglobulinemia: CAR-T therapy may cause a decrease in immunoglobulin levels, which can increase the risk of infections.
• Secondary Malignancies: There is a potential risk of developing other cancers as a result of CAR-T therapy, although this risk appears to be low.

It’s important to note that not all patients will experience these side effects, and their severity can vary from person to person. Healthcare providers closely monitor patients receiving CAR-T therapy for signs of side effects and provide appropriate management and supportive care as needed.

Patients should discuss potential side effects and management strategies with their healthcare team before undergoing CAR-T therapy. Early recognition and intervention can help minimize the impact of side effects and optimize treatment outcomes.

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

Storage and Disposal:

• • Brexucabtagene autoleucel injection is usually stored and prepared in specialized healthcare facilities equipped for CAR-T therapy administration.
  • Healthcare providers handle the storage and disposal of unused or expired medication according to institutional protocols and regulatory guidelines.
  • Patients should not attempt to store or dispose of brexucabtagene autoleucel injection at home.

In case of emergency/overdose

• In the event of a medical emergency or overdose related to brexucabtagene autoleucel injection, patients should seek immediate medical attention by contacting their healthcare provider, going to the nearest emergency department, or calling emergency services (e.g., 911).
• Healthcare providers are trained to manage emergencies associated with CAR-T therapy, including severe side effects such as cytokine release syndrome (CRS) or neurologic toxicities.

What other information should I know?

• Patients receiving brexucabtagene autoleucel injection should undergo comprehensive pre-treatment evaluations to assess their eligibility for CAR-T therapy and identify potential risk factors for adverse reactions.
• It’s important for patients to adhere to all recommended follow-up appointments and monitoring visits with their healthcare provider to assess treatment response, manage side effects, and address any concerns.
• Patients and caregivers should receive education and instructions from healthcare providers regarding signs and symptoms of potential side effects, as well as appropriate steps to take in case of emergency.
• Patients should inform their healthcare team about all medications, supplements, and herbal products they are taking, as some substances may interact with brexucabtagene autoleucel or affect treatment outcomes.

Overall, patients undergoing brexucabtagene autoleucel injection should rely on the guidance and support of their healthcare team for all aspects of treatment, including storage, disposal, emergency management, and other important considerations.