WARNING

Ciltacabtagene autoleucel (cilta-cel) is a type of CAR T-cell therapy used to treat certain types of B-cell lymphomas. Like all medical treatments, it carries risks and potential side effects:

• Cytokine Release Syndrome (CRS): This is a common side effect where the immune cells activated by the therapy release cytokines, causing flu-like symptoms (fever, chills, fatigue) and, in severe cases, organ dysfunction.
• Neurological Toxicity: Some patients may experience neurologic symptoms such as confusion, delirium, tremors, or seizures. These can be mild to severe and require close monitoring.
• Infections: The therapy can lower the body’s immune response, increasing the risk of infections, which can be severe.
• Hypogammaglobulinemia: This therapy can reduce the levels of immunoglobulins in the blood, which are essential for fighting infections.
• Blood Disorders: It can cause low blood cell counts, including red blood cells, white blood cells, and platelets.
• Tumor Lysis Syndrome: Rapid breakdown of cancer cells can lead to metabolic disturbances, affecting the kidneys, heart, and other organs.
• Secondary Cancers: There is a small risk of developing other cancers later on due to the genetic modifications and the therapy’s effects on the immune system.

Patients undergoing ciltacabtagene autoleucel therapy require careful monitoring in a specialized healthcare setting due to these potential risks. Treatment decisions should be made in consultation with healthcare providers, weighing the risks against the potential benefits for each individual case.

Why is this medication prescribed?

Ciltacabtagene autoleucel (cilta-cel) injection is prescribed for the treatment of certain types of B-cell lymphomas, specifically:

• Relapsed or Refractory Large B-cell Lymphoma (DLBCL): This includes diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
• High-grade B-cell Lymphoma: This refers to aggressive lymphomas that may not respond to standard treatments or have relapsed after initial therapy.

Cilta-cel is a type of CAR T-cell therapy, which stands for chimeric antigen receptor T-cell therapy. It works by genetically modifying a patient’s own T-cells to recognize and attack cancer cells that express a specific protein called CD19 on their surface. This treatment is considered when other treatments have not been effective or when other options are not suitable.

How should this medicine be used?

How Ciltacabtagene Autoleucel Injection Should be Used:

• Preparation: Before receiving cilta-cel, patients typically undergo a process called leukapheresis. During this procedure, white blood cells (including T-cells) are collected from the patient’s blood.
• Manufacturing: The collected T-cells are then sent to a specialized laboratory where they are genetically modified to express a chimeric antigen receptor (CAR) that targets CD19 on cancer cells. This process takes several weeks.
• Conditioning Regimen: Before receiving the modified T-cells, patients usually undergo a conditioning regimen which involves chemotherapy to suppress the immune system and prepare the body to receive the CAR T-cells.
• Infusion: Once the modified T-cells (cilta-cel) are ready, they are infused back into the patient’s bloodstream. This infusion is a one-time treatment.
• Monitoring: Patients are closely monitored for potential side effects, particularly in the initial days and weeks following infusion. This monitoring is crucial due to the risk of complications such as cytokine release syndrome (CRS) and neurological toxicity.

Ciltacabtagene autoleucel therapy is typically administered in specialized healthcare settings by healthcare providers experienced in CAR T-cell therapies. The treatment requires careful management to ensure safety and effectiveness.

Other uses for this medicine

Currently, ciltacabtagene autoleucel (cilta-cel) injection is specifically approved for the treatment of certain types of B-cell lymphomas, particularly relapsed or refractory large B-cell lymphoma (including DLBCL) and high-grade B-cell lymphoma. Its use in other conditions or cancers is not approved or established at this time.

What special precautions should I follow?

Special Precautions for Ciltacabtagene Autoleucel Injection:

• Specialized Healthcare Setting: Treatment with cilta-cel should be conducted in specialized healthcare facilities that have experience in administering CAR T-cell therapies and managing potential complications.
• Monitoring: Patients should be closely monitored during and after infusion for signs of cytokine release syndrome (CRS), neurologic toxicity, infections, and other potential adverse reactions.
• Risk of Infections: Due to the immune-suppressive effects of the therapy, patients are at increased risk of infections. Prophylactic medications and monitoring for signs of infections are often recommended.
• Risk of Hypogammaglobulinemia: Cilta-cel can lead to low levels of immunoglobulins (antibodies) in the blood, increasing the risk of infections. Monitoring and replacement therapy may be necessary.
• Long-term Follow-up: Patients who receive CAR T-cell therapies like cilta-cel require long-term follow-up to monitor for potential late effects, including secondary cancers and prolonged immune dysfunction.
• Patient Education: Patients and caregivers should receive comprehensive education about potential side effects, the importance of adherence to follow-up appointments, and recognizing signs of complications that require immediate medical attention.
• Pregnancy and Breastfeeding: The safety of cilta-cel during pregnancy and breastfeeding has not been established. Patients should discuss fertility preservation options and contraceptive measures with their healthcare provider before starting treatment.
• Medication Interactions: Patients should inform their healthcare providers about all medications, supplements, and herbal products they are taking, as some may interact with cilta-cel or affect its efficacy or safety.
• Driving and Activities: Due to potential neurologic side effects, patients should be cautious about driving or operating machinery until they know how cilta-cel affects them.

It’s crucial for patients to discuss all potential risks and precautions with their healthcare team before starting treatment with cilta-cel. Close collaboration between the patient, caregivers, and healthcare providers is essential to ensure safe and effective management of this therapy.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with cilta-cel therapy. However, it’s important to maintain a balanced and nutritious diet to support your overall health and immune function during treatment.

What should I do if I forget a dose?

Since cilta-cel therapy involves a single infusion rather than daily doses, there are no “doses” to forget in the traditional sense. However, if you have concerns about missed appointments or follow-up visits, it’s important to contact your healthcare provider promptly to reschedule and ensure continuity of care.

What side effects can this medication cause?

Ciltacabtagene autoleucel (cilta-cel) injection, like other CAR T-cell therapies, can cause a range of side effects. These side effects can vary in severity and may require prompt medical attention. Common side effects include:

• Cytokine Release Syndrome (CRS): This is a common and potentially serious side effect characterized by flu-like symptoms such as fever, chills, nausea, headache, and in severe cases, low blood pressure, breathing difficulties, and organ dysfunction.
• Neurologic Toxicity: Some patients may experience neurologic side effects, ranging from mild confusion, headache, and tremors to more severe symptoms such as seizures, delirium, and impaired consciousness.
• Infections: Due to the suppression of the immune system by cilta-cel therapy, there is an increased risk of infections. These can include bacterial, viral, fungal, or other opportunistic infections.
• Hypogammaglobulinemia: This therapy can lower levels of immunoglobulins (antibodies) in the blood, which may increase susceptibility to infections.
• Hematologic Toxicities: These may include low levels of red blood cells (anemia), white blood cells (neutropenia), and platelets (thrombocytopenia), which can lead to fatigue, increased risk of bleeding, and increased susceptibility to infections.
• Febrile Neutropenia: A condition characterized by fever and low neutrophil count, which can increase the risk of serious infections.
• Tumor Lysis Syndrome: Rapid breakdown of cancer cells can lead to metabolic abnormalities such as high levels of potassium, phosphate, and uric acid in the blood, which can affect kidney function and lead to other complications.
• Secondary Cancers: There is a small risk of developing secondary cancers, possibly due to the effects of genetic modification and immune system alterations.
• Cardiac Toxicity: Rarely, cilta-cel therapy may cause heart-related issues such as arrhythmias (irregular heartbeats) or decreased heart function.
• Other: Other potential side effects include infusion reactions, gastrointestinal symptoms (such as diarrhea or abdominal pain), skin reactions, and muscle pain.

It’s important to note that not all patients will experience these side effects, and the severity can vary widely among individuals. Patients undergoing cilta-cel therapy are closely monitored by healthcare professionals to detect and manage these side effects promptly. Management strategies may include supportive care, medications to manage symptoms, and in severe cases, interventions to address specific complications.

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

Storage and Disposal:

• Storage: Cilta-cel is typically administered in a healthcare setting where storage conditions are carefully controlled by healthcare professionals. As a patient, you do not need to store the medication at home.
• Disposal: Any unused portion of cilta-cel or materials used in its administration (such as infusion bags or tubing) should be disposed of according to medical waste disposal guidelines. This is typically handled by the healthcare facility where the treatment is administered.

In case of emergency/overdose

• Emergency: If you experience severe side effects or complications after receiving cilta-cel, such as difficulty breathing, severe confusion, seizures, severe fever, or any other serious symptoms, seek emergency medical help immediately. Call emergency services or go to the nearest emergency room.
• Overdose: There is no specific antidote for an overdose of cilta-cel. Overdose in this context would typically refer to severe complications of treatment rather than a traditional overdose scenario. Management would involve supportive care and treatment of symptoms as guided by healthcare professionals.

What other information should I know?

• Follow-Up Care: After receiving cilta-cel, you will need regular follow-up appointments with your healthcare provider. These visits are important to monitor your response to treatment, manage any side effects, and assess your overall health.
• Patient Education: It’s essential to understand the potential side effects of cilta-cel and how to recognize them. Be sure to discuss any concerns or questions with your healthcare team.
• Monitoring: You will be closely monitored for at least several weeks after receiving cilta-cel infusion to watch for potential side effects such as cytokine release syndrome (CRS) and neurologic toxicity.
• Long-Term Effects: While the immediate focus is on managing acute side effects, it’s also important to discuss potential long-term effects of cilta-cel therapy, including monitoring for secondary cancers and immune system recovery.
• Supportive Care: Depending on your individual needs and responses to treatment, supportive care measures such as medications for infections, transfusions for low blood counts, and other supportive therapies may be necessary.
• Healthcare Team Communication: Maintain open communication with your healthcare team. Inform them about any new symptoms, changes in your health status, or medications you may be taking.

Always rely on the guidance and instructions provided by your healthcare provider regarding the safe administration, monitoring, and management of cilta-cel therapy. They are your best resource for personalized care and support throughout your treatment journey.