WARNING

Abecma (generic name Idecabtagene Vicleucel) is a CAR-T cell therapy used to treat certain types of multiple myeloma. While it can be effective, it comes with risks:

• Cytokine Release Syndrome (CRS): A potentially severe reaction where the immune system releases a large number of cytokines into the bloodstream, causing symptoms like fever, fatigue, and in severe cases, organ dysfunction.
• Neurotoxicity: This can include symptoms such as confusion, difficulty speaking, or seizures.
• Infections: Due to the therapy affecting the immune system, there’s an increased risk of infections.
• B Cell Aplasia: The therapy can reduce the number of normal B cells, which may lead to a higher risk of infections.
• Hematologic Toxicities: These include issues like anemia, thrombocytopenia (low platelet count), and neutropenia (low white blood cell count).

Patients receiving Abecma are monitored closely to manage and mitigate these risks.

Why is this medication prescribed?

Abecma (idecabtagene vicleucel) is prescribed for the treatment of multiple myeloma, specifically for adult patients who have:

• Relapsed or Refractory Multiple Myeloma: This means the disease has returned or has not responded to other treatments. It’s often used when patients have not responded to at least four prior lines of therapy, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies.
• Prior Treatments: It is generally prescribed for patients who have undergone multiple lines of treatment, including other types of chemotherapy and targeted therapies, but have not achieved remission or adequate disease control.

Abecma works by modifying a patient’s own T-cells to target and attack cancer cells specifically expressing the BCMA (B-cell maturation antigen) protein, which is commonly found on myeloma cells. This personalized approach can be effective in cases where other treatments have failed.

How should this medicine be used?

Abecma (idecabtagene vicleucel) is administered as a one-time infusion, but its use involves several important steps:

• Pre-Treatment Evaluation: Patients undergo a thorough evaluation, including assessing their overall health and specific characteristics of their cancer.
• Lymphodepleting Chemotherapy: Before receiving Abecma, patients typically receive a regimen of lymphodepleting chemotherapy. This step helps to make space in the immune system for the CAR T-cells to proliferate and be effective.
• CAR T-Cell Infusion: Abecma is given as an intravenous (IV) infusion. The infusion process usually takes about 30 minutes to 1 hour.
• Post-Infusion Monitoring: After the infusion, patients are closely monitored in a healthcare setting for several days to manage potential side effects, such as cytokine release syndrome (CRS) and neurotoxicity.
• Follow-Up Care: Ongoing follow-up is crucial to monitor for long-term effects, manage any complications, and assess the effectiveness of the treatment.

Abecma should only be administered by healthcare professionals experienced in CAR T-cell therapy due to the complexity and potential risks involved.

Other uses for this medicine

Abecma is primarily used for treating multiple myeloma in adults who have not responded to other treatments. Its use outside of this indication is not well-established or recommended.

What special precautions should I follow?

Special precautions include:

• Monitor for Side Effects: Regularly check for signs of cytokine release syndrome (CRS) and neurotoxicity, such as high fever, severe headaches, confusion, or seizures. Report any symptoms immediately.
• Infection Control: Be vigilant about infection risks. Your immune system will be compromised, so follow all infection prevention protocols and report any signs of infection (fever, chills, etc.) to your healthcare provider.
• Pregnancy and Breastfeeding: Avoid use if you are pregnant or breastfeeding, as the effects on the fetus or infant are not well understood.
• Medical History: Inform your healthcare team about any existing health conditions, especially related to heart, lung, or neurological health.
• Vaccinations: Consult your healthcare provider before receiving any vaccines, as some may not be suitable during or after treatment.

Close collaboration with your healthcare team is essential to manage these precautions effectively.

What special dietary instructions should I follow?

There are no specific dietary restrictions tied directly to Abecma. However, maintaining a balanced diet can support overall health and recovery. If you have specific concerns or conditions that might affect your diet, consult your healthcare provider or a dietitian.

What should I do if I forget a dose?

Abecma is administered as a one-time infusion. If you miss your scheduled infusion, contact your healthcare provider immediately to reschedule. They will guide you on the next steps.

What side effects can this medication cause?

Abecma (idecabtagene vicleucel) can cause several side effects. Some of the most common and notable ones include:

• Cytokine Release Syndrome (CRS): This can cause symptoms like fever, chills, nausea, fatigue, and in severe cases, it can lead to more serious complications such as low blood pressure or organ dysfunction.
• Neurotoxicity: Symptoms can range from mild (headaches, confusion) to severe (seizures, encephalopathy). It is critical to monitor neurological symptoms closely.
• Infections: Because the therapy impacts the immune system, there is an increased risk of infections. Patients should be monitored for signs of infection and may need prophylactic antibiotics or antivirals.
• B-cell Aplasia: This condition results in a reduced number of normal B cells, which can lead to increased susceptibility to infections and potential complications.
• Hypogammaglobulinemia: Low levels of immunoglobulins can occur, which might increase the risk of infections.
• Fatigue: General tiredness or weakness can occur following the infusion.
• Low Blood Counts: Abecma can cause reductions in red blood cells, white blood cells, and platelets, leading to anemia, increased risk of bleeding, or infections.
• Allergic Reactions: Some patients might experience allergic reactions to the infusion, though this is less common.

Close monitoring and prompt management of these side effects are crucial for ensuring patient safety and optimizing treatment outcomes. Always report any new or worsening symptoms to your healthcare provider immediately.

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

• Storage: Abecma is handled and prepared by healthcare professionals. It should be stored according to the manufacturer’s instructions, typically in a controlled, sterile environment. It is not stored by patients.
• Disposal: Disposal is managed by healthcare providers or facilities according to medical waste protocols.

In case of emergency/overdose

• Emergency: If you experience severe side effects like high fever, confusion, or difficulty breathing, seek immediate medical attention. These could be signs of serious conditions like cytokine release syndrome or neurotoxicity.
• Overdose: Overdose is unlikely as Abecma is given as a one-time infusion. If there’s concern about any dosage errors, contact your healthcare provider immediately for guidance.

What other information should I know?

• Follow-Up Care: Regular follow-up appointments are essential for monitoring response and managing any long-term effects or complications.
• Support Resources: Consider connecting with support groups or counseling services for additional emotional and practical support during your treatment journey.
• Inform Healthcare Providers: Always inform all your healthcare providers about your Abecma treatment and any other medications or treatments you’re receiving to avoid potential interactions.

Keeping these guidelines in mind will help ensure that you use Abecma safely and effectively.