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Breyanzi (Generic Lisocabtagene Maraleucel Injection)

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WARNING

Breyanzi is a type of CAR T-cell therapy used to treat certain types of blood cancers, like large B-cell lymphoma. While it can be effective, there are risks associated with it. Some of the potential risks of taking Breyanzi include:

  • Cytokine release syndrome (CRS): This is a common side effect of CAR T-cell therapy and can cause symptoms ranging from mild flu-like symptoms to more severe complications like low blood pressure and organ dysfunction.
  • Neurologic toxicities: These can include confusion, difficulty speaking or understanding speech, seizures, and even coma. These symptoms can be temporary or long-lasting.
  • Serious infections: Because Breyanzi works by suppressing the immune system, it can increase the risk of serious infections.
  • Prolonged low blood cell counts: Breyanzi can cause a drop in blood cell counts, which can increase the risk of bleeding and infection.
  • Secondary cancers: There is a risk of developing other types of cancer after treatment with Breyanzi.

It’s important for patients considering Breyanzi to discuss these risks with their healthcare provider and weigh them against the potential benefits of the treatment. Close monitoring during and after treatment is also crucial to manage any potential side effects.

Why is this medication prescribed?

Breyanzi is prescribed to treat certain types of large B-cell lymphoma in adults. Specifically, it is used for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults who have not responded well to other treatments or whose cancer has returned after previous treatment. DLBCL is the most common type of non-Hodgkin lymphoma, and Breyanzi is indicated for patients who have not responded to at least two prior lines of systemic therapy.

How should this medicine be used?

Breyanzi is administered as a one-time infusion by a healthcare professional in a specialized treatment center. Here’s a general overview of how Breyanzi is typically used:

  • Patient Evaluation: Before starting treatment with Breyanzi, patients undergo a thorough evaluation by their healthcare team to ensure they are suitable candidates for the therapy. This evaluation includes assessing the patient’s overall health, disease status, and any prior treatments.
  • Collection of T cells: Breyanzi is a type of CAR T-cell therapy, which means it involves modifying a patient’s own immune cells (T cells) to attack cancer cells. To do this, T cells are collected from the patient’s blood through a process called leukapheresis.
  • Manufacturing: The collected T cells are sent to a specialized laboratory where they are genetically modified to express chimeric antigen receptors (CARs) that target specific proteins on the surface of cancer cells.
  • Preparation for infusion: Once the CAR T cells are manufactured, they are shipped back to the treatment center where they will be administered to the patient. Before infusion, patients may undergo a short course of chemotherapy to help prepare their immune system for receiving the CAR T cells.
  • Infusion: The Breyanzi infusion is typically given as a single dose through a vein (intravenous infusion). The infusion process usually takes a few hours, and patients are monitored closely during and after the infusion for any signs of adverse reactions, such as cytokine release syndrome (CRS) or neurologic toxicities.
  • Monitoring and follow-up: After receiving Breyanzi, patients are closely monitored for potential side effects and complications. This monitoring typically continues for several weeks to months after treatment. Patients may also undergo periodic imaging scans and blood tests to assess the response to therapy.

It’s important for patients to follow their healthcare provider’s instructions carefully and to report any concerning symptoms or side effects promptly. Additionally, patients may need to take precautions to reduce the risk of infections while their immune system is recovering after treatment with Breyanzi.

Other uses for this medicine

As of my last update, Breyanzi is specifically approved for the treatment of certain types of blood cancers, particularly relapsed or refractory large B-cell lymphoma. Its use is typically limited to patients who have not responded to or have relapsed after at least two prior lines of systemic therapy.

What special precautions should I follow?

Regarding special precautions for Breyanzi, there are several important considerations:

  • Pre-treatment Evaluation: Before receiving Breyanzi, patients undergo thorough evaluations to assess their overall health, disease status, and suitability for the therapy. This evaluation includes blood tests, imaging studies, and assessment of organ function.
  • Risk Evaluation and Management: Healthcare providers assess the patient’s risk of developing cytokine release syndrome (CRS) and neurologic toxicities, which are common side effects of CAR T-cell therapy. Strategies for monitoring and managing these potential complications are implemented before, during, and after treatment.
  • Monitoring During Infusion: Patients receiving Breyanzi are closely monitored during the infusion process for any signs of adverse reactions, such as fever, chills, low blood pressure, or difficulty breathing. Healthcare providers are trained to manage these reactions promptly.
  • Post-treatment Monitoring: After receiving Breyanzi, patients require close monitoring for potential side effects and complications. This monitoring typically includes regular assessments of vital signs, blood tests, and imaging studies. Patients are instructed to report any concerning symptoms to their healthcare provider immediately.
  • Infection Prevention: Due to the immunosuppressive effects of Breyanzi, patients are at increased risk of developing infections, including bacterial, viral, and fungal infections. Patients may receive antibiotics or antiviral medications to prevent infections, and they are advised to avoid close contact with individuals who are sick.
  • Long-term Follow-up: Patients who receive Breyanzi require long-term follow-up to monitor for disease recurrence, late-onset side effects, and secondary cancers. Regular follow-up visits with healthcare providers are essential for ongoing management and surveillance.

It’s important for patients to discuss any questions or concerns about Breyanzi with their healthcare provider before starting treatment. Additionally, patients should inform their healthcare team about any medications, supplements, or underlying medical conditions they have to ensure safe and effective treatment with Breyanzi.

What special dietary instructions should I follow?

  • There are typically no specific dietary restrictions associated with Breyanzi. However, it’s always a good idea to maintain a balanced diet and stay hydrated unless otherwise advised by your healthcare provider.
  • If you have any concerns about diet and medication interactions, consult your healthcare provider or a registered dietitian for personalized advice.

What should I do if I forget a dose?

  • If you miss a dose of Breyanzi, contact your healthcare provider or treatment team for guidance as soon as possible.
  • They will advise you on the best course of action, which may include rescheduling the missed dose or adjusting your treatment plan.
  • Do not attempt to double up on doses to make up for a missed one without consulting your healthcare provider first.

What side effects can this medication cause?

Breyanzi, like many medications, can cause side effects. It’s important to be aware of these potential side effects and to discuss any concerns with your healthcare provider. Here are some common side effects associated with Breyanzi:

  • Infusion-related reactions: These can occur during or shortly after the infusion of Breyanzi and may include symptoms such as fever, chills, nausea, headache, fatigue, flushing, dizziness, and difficulty breathing. Your healthcare provider will monitor you closely during the infusion and may administer medications to manage these reactions.
  • Cytokine release syndrome (CRS): This is a systemic inflammatory response that can occur after receiving Breyanzi and may cause symptoms such as fever, fatigue, muscle aches, rapid heartbeat, low blood pressure, and difficulty breathing. CRS is typically managed by your healthcare provider with supportive care measures.
  • Neurological toxicity: Some patients may experience neurological side effects such as confusion, delirium, tremor, seizures, and hallucinations. Notify your healthcare provider immediately if you experience any neurological symptoms.
  • Infections: Breyanzi can weaken the immune system, increasing the risk of infections. Common infections may include bacterial, viral, or fungal infections. Notify your healthcare provider if you develop signs or symptoms of an infection, such as fever, chills, cough, sore throat, or difficulty breathing.
  • Low blood cell counts: Breyanzi may cause a decrease in white blood cell, red blood cell, and platelet counts, which can increase the risk of infections, anemia, and bleeding. Your healthcare provider will monitor your blood counts regularly during treatment.
  • Tumor lysis syndrome: This is a potentially life-threatening complication that can occur when cancer cells break down rapidly, releasing their contents into the bloodstream. Symptoms may include nausea, vomiting, diarrhea, kidney failure, seizures, and irregular heartbeat. Your healthcare provider will take precautions to prevent and manage tumor lysis syndrome.
  • Other side effects: Additional side effects of Breyanzi may include fatigue, nausea, diarrhea, vomiting, muscle pain, joint pain, and rash.

It’s important to report any side effects or concerns to your healthcare provider promptly. They can provide guidance on managing side effects and adjust your treatment plan if necessary to ensure your safety and well-being during Breyanzi therapy.

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

Storage and disposal of Breyanzi:

  • Storage: Breyanzi is typically stored by the healthcare provider or treatment facility where it will be administered. It is usually stored under specific conditions recommended by the manufacturer, such as refrigeration or controlled room temperature. Patients should not attempt to store Breyanzi at home.
  • Disposal: Since Breyanzi is administered as a one-time infusion in a clinical setting, patients do not need to worry about disposal. Any unused portions or medical waste related to the administration of Breyanzi will be handled by the healthcare provider or treatment facility according to established protocols for the disposal of biohazardous materials.

In case of emergency/overdose

  • Seek Medical Attention: If you experience any concerning symptoms or adverse reactions after receiving Breyanzi, such as severe infusion-related reactions, neurologic symptoms, or signs of infection, seek immediate medical attention. Contact your healthcare provider or go to the nearest emergency room for evaluation and treatment.
  • Report the Incident: In the event of an emergency or overdose involving Breyanzi, it’s essential to report the incident to your healthcare provider, treatment facility, or local regulatory authorities. They can provide guidance on appropriate management and reporting procedures.

What other information should I know?

  • Follow-up Care: After receiving Breyanzi, patients typically require regular follow-up appointments with their healthcare provider for ongoing monitoring of treatment response and potential side effects. Be sure to attend all scheduled follow-up visits and communicate any changes in your health status to your healthcare team.
  • Informed Consent: Before undergoing treatment with Breyanzi, patients are usually required to provide informed consent, which involves understanding the potential risks, benefits, and alternatives to the therapy. Take the time to discuss any questions or concerns with your healthcare provider before consenting to treatment.
  • Patient Support Resources: There may be resources available to provide support and assistance to patients receiving Breyanzi, such as patient advocacy organizations, support groups, and financial assistance programs. Your healthcare provider or treatment facility can help connect you with these resources if needed.
  • Medical History: It’s important to inform your healthcare provider about your complete medical history, including any underlying health conditions, medications you are taking (including prescription, over-the-counter, and herbal supplements), and any previous treatments for cancer or other medical conditions.

By staying informed and actively participating in your treatment plan, you can help ensure safe and effective use of Breyanzi and optimize your overall care experience.

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