WARNING

Tecartus (brexucabtagene autoleucel) is a type of CAR T-cell therapy used to treat certain types of lymphoma. While it can be effective in treating cancer, there are risks associated with its use:

• Cytokine Release Syndrome (CRS): Tecartus can cause CRS, which is a severe immune response that can lead to fever, low blood pressure, difficulty breathing, and organ dysfunction.
• Neurologic Toxicities: Some patients may experience neurologic side effects such as confusion, seizures, or difficulty speaking, which can be severe and potentially life-threatening.
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): This is a syndrome characterized by neurological symptoms such as confusion, delirium, and in severe cases, cerebral edema.
• Risk of Infection: Tecartus treatment can suppress the immune system, increasing the risk of infections, some of which may be serious or fatal.
• Tumor Lysis Syndrome (TLS): Rapid breakdown of cancer cells can lead to TLS, causing metabolic imbalances that may result in kidney failure, abnormal heart rhythms, or seizures.
• Long-Term Effects: Long-term effects of Tecartus therapy are still being studied, but potential risks may include secondary cancers or autoimmune disorders.

It’s essential for patients considering Tecartus treatment to discuss the potential risks and benefits with their healthcare provider. Close monitoring and management of side effects are critical for patient safety.

Why is this medication prescribed?

Tecartus is prescribed for the treatment of certain types of lymphoma, specifically relapsed or refractory mantle cell lymphoma (MCL) in adult patients who have received at least two prior therapies. It is a form of CAR T-cell therapy, where a patient’s own T cells are genetically modified to recognize and attack cancer cells expressing the CD19 antigen.

How should this medicine be used?

Here’s how Tecartus is typically used:

• Collection of T Cells: Before treatment with Tecartus, a patient’s own T cells are collected via a process called leukapheresis. This involves removing blood from the patient, separating out the T cells, and returning the remaining blood components to the patient.
• Genetic Modification: The collected T cells are then sent to a laboratory where they are genetically modified to express a chimeric antigen receptor (CAR) that targets CD19 on the surface of cancer cells.
• Conditioning Chemotherapy: Before receiving the modified T cells, patients typically undergo conditioning chemotherapy to suppress their existing immune system and prepare their body to receive the CAR T-cell therapy.
• Infusion of Tecartus: Once the modified T cells are ready, they are infused back into the patient’s bloodstream. This infusion is usually done as a single treatment.
• Monitoring and Supportive Care: After receiving Tecartus, patients are closely monitored for potential side effects such as cytokine release syndrome (CRS) and neurologic toxicities. Supportive care, including medications to manage side effects and monitoring for infections, is provided as needed.

It’s important for patients to follow their healthcare provider’s instructions carefully and to undergo regular follow-up appointments to monitor their response to treatment and manage any side effects.

Other uses for this medicine

Tecartus (brexucabtagene autoleucel) is primarily indicated for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in adult patients who have received at least two prior therapies. However, it’s essential to consult with a healthcare professional or refer to the most recent medical literature for any updates on its approved uses or clinical trials for other indications.

What special precautions should I follow?

Special precautions to follow for Tecartus treatment include:

• Patient Selection: Tecartus therapy is typically recommended for patients who have failed other treatments for mantle cell lymphoma. Healthcare providers carefully evaluate patients’ eligibility for this therapy based on various factors, including overall health status and previous treatment history.
• Monitoring for Side Effects: Patients receiving Tecartus should be closely monitored for potential side effects, including cytokine release syndrome (CRS), neurologic toxicities, infections, and tumor lysis syndrome (TLS). Monitoring may involve regular assessments of vital signs, laboratory tests, and neurological evaluations.
• Management of Side Effects: Healthcare providers should be prepared to manage potential side effects associated with Tecartus promptly. This may involve providing supportive care, administering medications to alleviate symptoms (such as corticosteroids for CRS or neurologic toxicities), and possibly interrupting or discontinuing Tecartus treatment if necessary.
• Infection Prevention: Due to the immunosuppressive effects of Tecartus, patients are at an increased risk of infections. Healthcare providers may recommend precautions to reduce the risk of infections, such as avoiding close contact with individuals who are sick and practicing good hygiene measures.
• Long-Term Monitoring: Patients who have received Tecartus should undergo long-term monitoring to assess treatment efficacy, monitor for disease relapse, and evaluate for potential long-term side effects or complications.
• Patient Education: Patients receiving Tecartus should receive thorough education about the treatment, including its potential risks and benefits, signs and symptoms of side effects, and the importance of adhering to follow-up appointments and medical advice.

It’s crucial for patients to have open communication with their healthcare providers throughout Tecartus treatment to address any concerns, monitor for side effects, and ensure optimal management of their condition.

What special dietary instructions should I follow?

Regarding special dietary instructions, there are no specific dietary restrictions associated with Tecartus treatment. However, maintaining a balanced and nutritious diet is essential for overall health and may help support the immune system during treatment. Patients should consult with their healthcare provider or a registered dietitian for personalized dietary recommendations.

What should I do if I forget a dose?

If a patient forgets a dose of Tecartus, they should contact their healthcare provider or treatment facility immediately for guidance. It’s crucial to follow healthcare provider instructions regarding missed doses, as the timing and management of missed doses may vary depending on individual circumstances and treatment protocols.

What side effects can this medication cause?

Tecartus (brexucabtagene autoleucel) can cause various side effects, some of which may be severe or life-threatening. Common side effects include:

• Cytokine Release Syndrome (CRS): CRS is a systemic inflammatory response that can occur after CAR T-cell therapy like Tecartus. Symptoms may include fever, chills, low blood pressure, rapid heartbeat, difficulty breathing, and flu-like symptoms. Severe cases of CRS can lead to organ dysfunction and require intensive medical intervention.
• Neurologic Toxicities: Some patients may experience neurologic side effects, such as confusion, delirium, headache, tremor, seizures, difficulty speaking, or decreased consciousness. Severe neurologic toxicities can be life-threatening and may require urgent medical attention.
• Infections: Tecartus treatment can weaken the immune system, increasing the risk of infections. Patients may develop bacterial, viral, or fungal infections, which may be severe or life-threatening.
• Tumor Lysis Syndrome (TLS): TLS can occur as a result of the rapid breakdown of cancer cells after treatment with Tecartus. This can lead to metabolic imbalances, such as high levels of potassium, phosphate, and uric acid in the blood, which may cause kidney damage, abnormal heart rhythms, or other complications.
• Hypogammaglobulinemia: Tecartus therapy may reduce levels of immunoglobulins (antibodies) in the blood, increasing the risk of infections.
• Hypotension: Low blood pressure (hypotension) may occur during or after Tecartus infusion, which may require supportive measures such as fluids or medications to manage.
• Febrile Neutropenia: Some patients may experience a fever associated with low white blood cell counts (neutropenia), which increases the risk of infections.
• Hematologic Toxicities: Tecartus treatment can affect blood cell counts, leading to low levels of red blood cells (anemia), white blood cells (neutropenia), and platelets (thrombocytopenia).
• Hypersensitivity Reactions: Rarely, patients may experience hypersensitivity reactions to components of Tecartus, which may manifest as rash, itching, or difficulty breathing.

It’s essential for patients to be closely monitored during and after Tecartus treatment for any signs or symptoms of these side effects. Prompt medical intervention may be necessary to manage side effects and ensure patient safety.

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

Storage and disposal of Tecartus:

• Storage: Tecartus is typically stored by the healthcare provider or treatment facility according to specific guidelines provided by the manufacturer. It is usually stored under controlled conditions to maintain its stability and effectiveness.
• Disposal: Any unused portion of Tecartus or materials used during its administration, such as infusion bags or tubing, should be disposed of according to local regulations for handling biological waste or hazardous materials. Healthcare providers or treatment facilities typically have protocols in place for the safe disposal of these materials.

In case of emergency/overdose

In case of emergency or overdose of Tecartus:

• Emergency Medical Assistance: If a patient experiences a medical emergency or suspects an overdose of Tecartus, they should seek immediate medical assistance by calling emergency services or going to the nearest emergency room.
• Contact Healthcare Provider: Patients or caregivers should also contact their healthcare provider or treatment facility for further guidance on managing the situation.

What other information should I know?

• Follow-Up Care: Patients who have received Tecartus should undergo regular follow-up appointments with their healthcare provider for monitoring of treatment response, assessment of potential side effects, and long-term management of their condition.
• Patient Education: Patients should receive thorough education about Tecartus treatment, including its purpose, potential risks and benefits, signs and symptoms of side effects, and the importance of adhering to follow-up appointments and medical advice.
• Supportive Care: Patients may require supportive care during and after Tecartus treatment to manage side effects and promote overall well-being. This may include medications, nutritional support, and psychological support.
• Consent Process: Tecartus treatment typically involves a comprehensive informed consent process, during which patients or their caregivers receive detailed information about the treatment, its potential risks and benefits, and alternatives. Patients should have the opportunity to ask questions and make informed decisions about their care.
• Reporting Adverse Events: Patients and healthcare providers should report any adverse events or side effects associated with Tecartus to the appropriate regulatory authorities, such as the U.S. Food and Drug Administration (FDA), as part of ongoing pharmacovigilance efforts.

Always consult with your healthcare provider or pharmacist for specific instructions and guidance regarding the storage, disposal, and management of Tebentafusp injection.