Lunsumio（Mosunetuzumab）- NHL｜HongKong DengYue Medicine

Mosunetuzumab Injection Application Scope

Mosunetuzumab/lunsumio is a bispecific monoclonal antibody used primarily in the treatment of B-cell non-Hodgkin lymphoma (NHL). It is specifically used in relapsed or refractory cases of B-cell lymphomas, including:

• Follicular lymphoma (FL)
• Diffuse large B-cell lymphoma (DLBCL)
• Chronic lymphocytic leukemia (CLL)

Mosunetuzumab works by targeting CD20 on malignant B-cells and CD3 on T-cells, redirecting T-cells to attack and kill B-cells. It is typically used for patients who have not responded to previous therapies such as chemotherapy or other immunotherapies.

Mosunetuzumab Package Insert

• Ingredients: Mosunetuzumab

• Properties:

  • Mosunetuzumab-axgb is a bispecific T-cell engager (BiTE) that binds both CD20 on B-cells and CD3 on T-cells, thereby facilitating T-cell-mediated destruction of malignant B-cells.
  • It is designed for intravenous infusion and is used in hematological malignancies, particularly B-cell lymphomas.

• Specification: 1 mg/mL single-dose vial/box; 30 mg/30 mL (1 mg/mL) single-dose vial/box

• Packaging Specification: Available in single-use vials, typically containing up to 20 mg per vial (the concentration may differ based on the specific formulation and dosage guidelines)

• Storage: Store at 2°C to 8°C (36°F to 46°F). Do not freeze

• Expiry Date: The product is generally stable for 2 to 3 years, depending on the specific formulation. Always check the expiry date on the packaging

• Approval Number: 2024/12/23

• Date of Revision: Date when the product information was last revised

• Manufacturer: Genentech, Inc.

Guidelines for the Use of Mosunetuzumab Injection

1. Indication:

   • Mosunetuzumab is indicated for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma, including:
     • Follicular lymphoma
     • Diffuse large B-cell lymphoma (DLBCL)
     • Chronic lymphocytic leukemia (CLL)
   • It is used particularly in patients who have failed previous therapies.

2. Administration:

   • Administered via intravenous infusion under medical supervision.
   • The infusion should be done slowly to minimize the risk of infusion-related reactions.
   • It is typically given over several cycles, with the infusion rate carefully controlled.

Dosage and Administration

• Initial Dose:

  • The typical loading dose is administered in divided doses over the course of a few weeks. A standard protocol may begin with a low dose (e.g., 1 mg) and then increase based on patient response.

• Administration Method:

  • The intravenous infusion is typically initiated at a slow rate (e.g., over 90 minutes for the first dose), and subsequent doses may be infused more quickly depending on the patient’s tolerance and clinical guidelines.

• Maintenance Dose:

  • The maintenance doses are usually given in cycles, with dose adjustments based on the patient’s clinical status and tumor response.

Adverse Reactions

• Mosunetuzumab Side Effects:

  • Infusion-related reactions: fever, chills, nausea, headache, and hypotension.
  • Cytopenias: neutropenia, thrombocytopenia, and anemia.
  • Fatigue, headache, or dizziness.

• Serious Side Effects:

  • Tumor Lysis Syndrome: Can occur in patients with high tumor burden. It is characterized by electrolyte imbalances and kidney damage.
  • Cytokine Release Syndrome (CRS): This may occur after the first dose and requires monitoring and management.
  • Neurological Toxicity: Encephalopathy or other central nervous system side effects.

Medication Limitations

• Contraindications:
  • Hypersensitivity to lunsumio (mosunetuzumab) or any of its excipients.
  • Severe allergic reactions to monoclonal antibodies.
• Precautions:
  • Infusion-related reactions: Monitor patients closely during and after the infusion, particularly for the first dose.
  • Immunosuppression: Use with caution in immunocompromised patients due to the risk of infections.
  • Tumor Lysis Syndrome: Especially in patients with a high tumor burden; preventive hydration and electrolyte monitoring may be needed.
  • Pregnancy and Lactation: Mosunetuzumab is not recommended during pregnancy and breastfeeding unless the potential benefit justifies the potential risk.

Mosunetuzumab Injection Interactions

• Drug Interactions:

  • Immunosuppressive agents: Caution when used in combination with other immunosuppressive drugs (e.g., corticosteroids or other biologics).
  • Chemotherapy agents: It may be used in combination with certain chemotherapy agents, but the risk of overlapping toxicities (e.g., myelosuppression) should be monitored.
  • Live vaccines: Avoid administration of live vaccines during treatment.

• Food and Alcohol:

  • There are no direct food or alcohol interactions. However, due to the potential for immune system suppression, it is recommended to limit alcohol use during treatment.

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from HongKong DengYue Medicine. It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.