WARNING

Epcoritamab-bysp, also known as GEN3013, is a novel bispecific antibody designed for the treatment of B-cell malignancies such as non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. While it shows promise in clinical trials for its ability to target cancer cells, there are potential risks associated with its use:

• Immune-related adverse events: Like many immunotherapies, epcoritamab-bysp can stimulate the immune system, leading to immune-related adverse events such as cytokine release syndrome (CRS) and immune-mediated toxicities.
• Infusion reactions: Some patients may experience infusion reactions during or shortly after receiving epcoritamab-bysp. These reactions can range from mild to severe and may include symptoms such as fever, chills, nausea, and allergic reactions.
• Neurotoxicity: Neurological side effects, including confusion, delirium, seizures, and other central nervous system effects, have been reported with the use of bispecific antibodies like epcoritamab-bysp.
• Infections: Treatment with epcoritamab-bysp can weaken the immune system, increasing the risk of infections. Patients may be susceptible to bacterial, viral, fungal, or other opportunistic infections.
• Hematologic toxicities: Epcoritamab-bysp may cause decreases in various blood cell counts, including red blood cells, white blood cells, and platelets, which can lead to anemia, neutropenia, and thrombocytopenia.
• Cardiac toxicity: There may be a risk of cardiac toxicity associated with epcoritamab-bysp, although this risk appears to be relatively low compared to other side effects.
• Other side effects: Additional side effects may occur, including gastrointestinal disturbances, fatigue, muscle weakness, and skin reactions.

It’s important for patients receiving epcoritamab-bysp to be closely monitored by their healthcare providers for any signs of adverse reactions, and to report any symptoms promptly. The benefits of treatment with epcoritamab-bysp should be carefully weighed against the potential risks in consultation with a healthcare professional.

Why is this medication prescribed?

Epcoritamab-bysp is prescribed for the treatment of certain types of B-cell malignancies, including non-Hodgkin’s lymphoma and chronic lymphocytic leukemia (CLL). It is specifically indicated for patients who have relapsed or refractory disease, meaning their cancer has not responded to previous treatments or has returned after an initial response.

As a bispecific antibody, epcoritamab-bysp works by targeting two different proteins on the surface of cancer cells and immune cells. By binding to both of these proteins simultaneously, it helps to direct the patient’s immune system to attack and destroy the cancer cells.

How should this medicine be used?

Epcoritamab-bysp is typically administered intravenously (IV) by a healthcare professional. The dosage and administration schedule can vary depending on factors such as the patient’s weight, overall health, and the specific type and stage of their cancer. However, the general guidelines for using epcoritamab-bysp are as follows:

• Preparation: Healthcare providers will prepare the epcoritamab-bysp solution according to the manufacturer’s instructions. This may involve diluting the medication in a sterile solution before administration.
• Administration: The medication is administered directly into a vein (intravenously) over a period of time specified by the healthcare provider. The infusion process typically takes several hours, and patients may be monitored closely during and after the infusion for any adverse reactions.
• Dosage: The dosage of epcoritamab-bysp can vary based on factors such as the patient’s weight, overall health, and the specific type and stage of their cancer. Healthcare providers will determine the appropriate dosage for each patient and adjust it as necessary based on their response to treatment and any side effects experienced.
• Treatment schedule: Epcoritamab-bysp is usually administered in cycles, with each cycle consisting of one or more treatment sessions followed by a period of rest. The exact schedule may vary depending on the individual patient and their response to treatment.
• Monitoring: Patients receiving epcoritamab-bysp will be closely monitored by their healthcare team for any signs of adverse reactions or complications. This may include regular blood tests to check for changes in blood cell counts and other markers of health.

It’s important for patients to follow their healthcare provider’s instructions carefully and attend all scheduled appointments for treatment and monitoring. Patients should also report any side effects or concerns to their healthcare team promptly so that appropriate management can be provided.

Other uses for this medicine

Epcoritamab-bysp (GEN3013) is primarily being studied and developed for the treatment of B-cell malignancies such as non-Hodgkin’s lymphoma and chronic lymphocytic leukemia (CLL), particularly in cases where the cancer has relapsed or is refractory to other treatments. Its primary use is within the context of clinical trials and investigational settings for these indications.

What special precautions should I follow?

Some general precautions and considerations for patients receiving epcoritamab-bysp may include:

• Medical supervision: Epcoritamab-bysp is typically administered under the supervision of healthcare professionals experienced in the management of cancer and immunotherapy. Patients should receive treatment in a healthcare facility equipped to manage potential infusion reactions and other side effects.
• Monitoring: Patients receiving epcoritamab-bysp will be closely monitored by their healthcare team during and after treatment for any signs of adverse reactions or complications. This may include regular blood tests to monitor blood cell counts and other markers of health.
• Infection prevention: Since epcoritamab-bysp can weaken the immune system, patients may be at an increased risk of infections. It’s important to follow good hygiene practices and minimize exposure to infectious agents. Patients should also promptly report any signs or symptoms of infection to their healthcare provider.
• Infusion reactions: Some patients may experience infusion reactions during or shortly after receiving epcoritamab-bysp. Healthcare providers will closely monitor patients during infusion and may administer medications to manage any reactions that occur.
• Neurological side effects: Patients should be monitored for any signs of neurological side effects, such as confusion, delirium, seizures, or other central nervous system effects. These should be promptly reported to the healthcare provider.
• Cardiac monitoring: Although the risk of cardiac toxicity appears to be relatively low with epcoritamab-bysp, patients may still undergo cardiac monitoring as deemed necessary by their healthcare provider.

It’s important for patients to communicate openly with their healthcare team about any concerns or questions regarding epcoritamab-bysp treatment. Additionally, patients should inform their healthcare provider about any other medications, supplements, or medical conditions they have before starting treatment with epcoritamab-bysp.

What special dietary instructions should I follow?

As of now, there are no specific dietary instructions associated with Epcoritamab-bysp. However, maintaining a balanced and nutritious diet can support overall health and may help patients tolerate treatment better. 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 Epcoritamab-bysp, they should contact their healthcare provider or treatment team for guidance. Depending on the specific treatment protocol and how far the patient is into the treatment cycle, the healthcare provider may recommend rescheduling the missed dose or adjusting the treatment plan accordingly. It’s important not to try to compensate for a missed dose by taking extra medication without consulting a healthcare professional.

What side effects can this medication cause?

As with any medication, Epcoritamab-bysp (GEN3013) may cause side effects. However, some common side effects associated with Epcoritamab-bysp and similar immunotherapies may include:

• Infusion reactions: Immediate reactions during or shortly after infusion, including fever, chills, nausea, vomiting, headache, fatigue, itching, rash, and shortness of breath.
• Cytokine release syndrome (CRS): A systemic inflammatory response that can cause symptoms such as fever, fatigue, nausea, headache, rash, low blood pressure, and organ dysfunction. Severe cases of CRS can be life-threatening and require prompt medical attention.
• Neurological side effects: Confusion, delirium, dizziness, seizures, tremors, and other central nervous system effects.
• Hematologic toxicities: Decreased blood cell counts, including anemia (low red blood cell count), neutropenia (low white blood cell count), and thrombocytopenia (low platelet count), which can increase the risk of infections, bleeding, and fatigue.
• Infections: Weakening of the immune system can increase susceptibility to bacterial, viral, fungal, or other opportunistic infections.
• Fatigue: Feeling tired or weak is a common side effect of many cancer treatments, including immunotherapy.
• Gastrointestinal disturbances: Nausea, vomiting, diarrhea, constipation, and abdominal pain.
• Skin reactions: Rash, itching, and other dermatological reactions.
• Cardiac toxicity: Although less common, immunotherapies like Epcoritamab-bysp may rarely cause cardiac side effects such as arrhythmias or decreased heart function.

It’s important to note that not all patients will experience these side effects, and their severity can vary from person to person. Additionally, new side effects may emerge as more data becomes available from ongoing clinical trials and real-world use. Patients should discuss potential side effects and their management with their healthcare provider before starting treatment with Epcoritamab-bysp.

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

Storage and disposal:

• Storage: Epcoritamab-bysp should be stored according to the manufacturer’s instructions, typically in a refrigerator at a temperature between 2°C to 8°C (36°F to 46°F). The medication should be protected from light and should not be frozen.
• Handling: Healthcare professionals should follow appropriate handling procedures for Epcoritamab-bysp to minimize the risk of contamination and ensure patient safety.
• Disposal: Unused or expired Epcoritamab-bysp should be disposed of properly according to local regulations. Patients should consult with their healthcare provider or pharmacist for guidance on safe disposal methods.

In case of emergency/overdose

In the event of an emergency or suspected overdose of Epcoritamab-bysp, patients or caregivers should:

• Seek medical attention immediately: Contact emergency medical services or go to the nearest hospital emergency room for evaluation and treatment.
• Provide information: Be prepared to provide information about the medication, including the name, dosage, and time of administration, as well as any symptoms experienced.
• Follow medical advice: Follow the instructions of healthcare professionals regarding further management of the overdose and any necessary supportive care.

What other information should I know?

• Pregnancy and breastfeeding: Patients should inform their healthcare provider if they are pregnant, planning to become pregnant, or breastfeeding before starting treatment with Epcoritamab-bysp. The potential risks and benefits of treatment should be discussed.
• Interactions: Patients should inform their healthcare provider about all medications, supplements, and herbal products they are taking before starting treatment with Epcoritamab-bysp, as it may interact with other medications.
• Regular monitoring: Patients receiving Epcoritamab-bysp will undergo regular monitoring by their healthcare provider to assess treatment response and monitor for side effects. This may include blood tests and other assessments.
• Patient support: Patients and caregivers may benefit from support services provided by healthcare facilities, patient advocacy organizations, or support groups for individuals with cancer.
• Follow-up care: Patients should follow their healthcare provider’s recommendations for follow-up care and monitoring after completing treatment with Epcoritamab-bysp.

As always, patients should consult with their healthcare provider or pharmacist for personalized guidance and additional information regarding the use of Epcoritamab-bysp.