WARNING

Carvykti, also known as Generic Ciltacabtagene Autoleucel Injection, is a type of CAR T-cell therapy used in the treatment of certain types of cancers, particularly multiple myeloma. While it can be highly effective, there are significant risks associated with this treatment:

• Cytokine Release Syndrome (CRS): This is a common side effect of CAR T-cell therapy, where the immune cells release cytokines (proteins that regulate immune responses) into the bloodstream. CRS can range from mild flu-like symptoms to severe complications such as low blood pressure, organ dysfunction, and even life-threatening conditions.
• Neurologic Toxicities: Patients undergoing CAR T-cell therapy can experience neurologic side effects, including confusion, delirium, seizures, and other central nervous system issues. These can vary in severity and may require close monitoring and intervention.
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): This term encompasses the neurologic toxicities associated with CAR T-cell therapy and can present as a range of symptoms affecting the brain and nervous system.
• Prolonged Cytopenias: Treatment with CAR T-cell therapy can lead to low blood cell counts (cytopenias), including low levels of white blood cells, red blood cells, and platelets, which may increase the risk of infections and bleeding.
• Risk of Infections: Patients undergoing CAR T-cell therapy are at an increased risk of infections due to compromised immune function, particularly during the period of immune reconstitution following treatment.
• Hypogammaglobulinemia: This refers to low levels of immunoglobulins (antibodies) in the blood, which can lead to an increased susceptibility to infections.
• Secondary Malignancies: There is a potential risk of developing secondary cancers as a result of CAR T-cell therapy, although this risk is still being studied and understood.

Patients receiving Carvykti or similar CAR T-cell therapies require careful monitoring and management by healthcare professionals experienced in handling these treatments and their associated risks. The benefits of these therapies in treating certain cancers must be weighed against the potential risks for each individual patient.

Why is this medication prescribed?

Carvykti (Generic Ciltacabtagene Autoleucel Injection) is prescribed for the treatment of certain types of cancer, particularly relapsed or refractory multiple myeloma in adults who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

How should this medicine be used?

How Carvykti Should be Used:

• Administration: Carvykti is administered as an intravenous infusion. The infusion is prepared specifically for each patient using their own T cells (autologous CAR T-cell therapy).
• Preparation: Before starting treatment with Carvykti, patients typically undergo leukapheresis to collect their T cells. These T cells are then genetically modified to express a chimeric antigen receptor (CAR) targeting BCMA (B-cell maturation antigen).
• Pre-treatment: Prior to receiving Carvykti, patients often undergo lymphodepleting chemotherapy, such as fludarabine and cyclophosphamide, to reduce the number of normal lymphocytes and enhance the expansion of CAR T cells.
• Infusion: The prepared CAR T cells are then infused back into the patient through an intravenous line. The infusion process usually takes place in a specialized healthcare setting, such as a hospital or a treatment center experienced in administering CAR T-cell therapies.
• Monitoring: After infusion, patients are closely monitored for potential side effects, such as cytokine release syndrome (CRS) and neurologic toxicities. Monitoring typically includes regular assessments of vital signs, blood counts, and symptoms for several weeks post-infusion.
• Follow-up: Long-term follow-up is essential to monitor the response to treatment, assess for potential late effects, and manage any ongoing side effects or complications.

It’s crucial for patients to receive Carvykti under the supervision of healthcare providers experienced in CAR T-cell therapy due to the complexity of the treatment and the potential for severe side effects. Treatment with Carvykti is personalized based on each patient’s specific condition and response to prior therapies.

Other uses for this medicine

Carvykti (Generic Ciltacabtagene Autoleucel Injection) is specifically approved and used for the treatment of relapsed or refractory multiple myeloma in adults who have undergone previous therapies, including specific agents like immunomodulatory agents, proteasome inhibitors, and anti-CD38 monoclonal antibodies. As of last update, it is not approved for other uses beyond this indication.

What special precautions should I follow?

Special Precautions for Carvykti:

• Specialized Treatment Centers: Carvykti should only be administered in healthcare facilities that have experience with CAR T-cell therapies and are equipped to manage potential complications.
• Monitoring: Patients receiving Carvykti require close monitoring for potential side effects, especially during the first few weeks post-infusion. This monitoring includes frequent assessments of vital signs, blood counts, and symptoms.
• Risk Evaluation and Mitigation Strategy (REMS): There may be a REMS program in place for Carvykti, which includes requirements for healthcare provider training, patient education, and monitoring to ensure safe use of the medication.
• Risk of Cytokine Release Syndrome (CRS): CRS is a significant potential side effect of CAR T-cell therapy. Healthcare providers should be vigilant for signs and symptoms of CRS, which can range from mild flu-like symptoms to severe systemic complications.
• Neurologic Toxicities: Patients should be monitored for neurologic symptoms such as confusion, delirium, seizures, and other neurologic issues that may arise as a result of CAR T-cell therapy.
• Infections: Due to the immunosuppressive effects of CAR T-cell therapy, patients are at increased risk of infections. Prophylactic antibiotics and antiviral medications may be prescribed to reduce this risk.
• Long-term Follow-up: Long-term follow-up is essential to monitor for late effects of treatment, including potential secondary malignancies and persistent immune dysfunction.
• Patient Education: Patients and caregivers should receive thorough education about the signs and symptoms of potential side effects, as well as the importance of adhering to follow-up appointments and reporting any concerning symptoms promptly.
• Pregnancy and Breastfeeding: Carvykti may have potential risks to a developing fetus, and its safety during breastfeeding is not established. Patients should discuss their pregnancy or breastfeeding status with their healthcare provider before starting treatment.

It’s crucial for patients receiving Carvykti to have a comprehensive treatment plan that includes ongoing monitoring and management of potential side effects. Close collaboration between patients, caregivers, and healthcare providers is essential for optimizing the safety and efficacy of CAR T-cell therapy with Carvykti.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Carvykti. However, it’s essential for patients undergoing treatment to maintain a balanced diet to support overall health and immune function. Patients should follow any dietary recommendations provided by their healthcare team, which may include guidelines for managing nausea, diarrhea, or other digestive symptoms that can occur as part of treatment.

What should I do if I forget a dose?

Since Carvykti is administered as a single infusion, there is no concern about forgetting a dose in the traditional sense of oral medications. However, it’s crucial to adhere to the schedule and follow the recommended monitoring and follow-up appointments as prescribed by your healthcare provider. Missing scheduled monitoring appointments could delay the detection of potential side effects or complications.

What side effects can this medication cause?

Carvykti (Generic Ciltacabtagene Autoleucel Injection), like other CAR T-cell therapies, can cause a range of side effects, some of which can be serious. These side effects typically arise from the immune system’s response to the infused CAR T cells. Common and serious side effects include:

• Cytokine Release Syndrome (CRS): CRS is a systemic inflammatory response caused by the release of cytokines from activated CAR T cells. Symptoms can range from mild flu-like symptoms (fever, chills, fatigue) to severe complications (low blood pressure, difficulty breathing, organ dysfunction). Severe CRS requires prompt medical intervention.
• Neurologic Toxicities: Neurologic side effects can occur, ranging from confusion and delirium to seizures and cerebral edema. These neurologic toxicities can be life-threatening and require close monitoring and management.
• Hypogammaglobulinemia: CAR T-cell therapy can lead to low levels of immunoglobulins (antibodies) in the blood, increasing the risk of infections.
• Prolonged Cytopenias: Treatment with Carvykti may result in low blood cell counts, including low levels of white blood cells, red blood cells, and platelets. This can increase the risk of infections and bleeding.
• Infections: Patients undergoing CAR T-cell therapy are at heightened risk of infections due to immune system suppression and the depletion of normal B cells.
• Febrile Neutropenia: This refers to a fever associated with a low count of neutrophils (a type of white blood cell), which can occur as a result of the treatment.
• Secondary Malignancies: There is a potential risk of developing secondary cancers following CAR T-cell therapy, although this risk is still being studied.
• Other Common Side Effects: Other less severe side effects may include nausea, diarrhea, fatigue, muscle pain, and headache.

It’s important for patients receiving Carvykti to be monitored closely by healthcare professionals experienced in managing CAR T-cell therapies. Early recognition and management of these side effects are crucial for minimizing complications and ensuring the best possible outcomes for patients undergoing this treatment.

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

Storage and Disposal of Carvykti:

• Storage: Carvykti is typically stored under specific conditions by the healthcare facility where it is administered. It may need to be stored frozen or refrigerated according to manufacturer instructions. Storage guidelines should be strictly followed to maintain the stability and efficacy of the product.
• Disposal: Any unused portion or materials associated with the preparation and administration of Carvykti should be disposed of according to local regulations for biohazardous waste. Healthcare providers are trained to handle and dispose of these materials safely.

In case of emergency/overdose

• Emergency: In case of any serious side effects or emergencies related to Carvykti, such as severe cytokine release syndrome (CRS) or neurologic toxicities, immediate medical attention should be sought. Healthcare providers should be informed of the specific details of the treatment and any symptoms experienced.
• Overdose: CAR T-cell therapies like Carvykti are not typically associated with traditional overdose scenarios because they are administered as a single infusion of genetically modified T cells. However, the occurrence of severe side effects, including CRS or neurologic toxicities, may be considered as manifestations of an excessive immune response. Management of overdose would involve supportive care and treatment of symptoms as per medical guidance.

What other information should I know?

• Follow-Up Care: Regular follow-up appointments are essential after receiving Carvykti to monitor for potential side effects, assess treatment response, and manage any long-term effects.
• Patient Education: Patients and caregivers should receive thorough education about the signs and symptoms of potential side effects, the importance of adherence to follow-up appointments, and how to contact healthcare providers in case of concerns or emergencies.
• Supportive Care: Depending on individual patient needs, supportive care such as hydration, electrolyte balance, and management of infections or other complications may be necessary during and after treatment with Carvykti.
• Clinical Trials: Participation in clinical trials may be an option for some patients to explore new therapies or treatment approaches for multiple myeloma or other conditions.
• Insurance Coverage: Since CAR T-cell therapies are specialized treatments, patients should check with their insurance provider regarding coverage, as these treatments can be expensive.
• Advance Directives: Given the potential for severe side effects, patients may consider discussing advance directives and healthcare preferences with their families and healthcare providers.

Understanding these aspects of Carvykti treatment can help ensure safe and effective management of this innovative therapy for eligible patients with relapsed or refractory multiple myeloma.