Gazyva (Obinutuzumab) – Follicular Lymphoma | HongKong DengYue Medicine

Obinutuzumab Application Scope

• Chronic Lymphocytic Leukemia (CLL): In combination with chlorambucil for patients with previously untreated CLL.

• Follicular Lymphoma (FL):

  • In combination with bendamustine followed by obinutuzumab monotherapy for patients who relapsed after or are refractory to a rituximab-containing regimen.

  • In combination with chemotherapy followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for previously untreated stage II bulky, III, or IV FL.

Obinutuzumab Characteristics

• Ingredients: Each vial contains 1,000 mg of obinutuzumab in 40 mL of solution, providing a concentration of 25 mg/mL.

• Properties: It is a humanized anti-CD20 monoclonal antibody of the IgG1 isotype.

• Packaging Specification: Single-dose vial containing 1,000 mg/40 mL.

• Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Do not shake.

• Expiry Date: Refer to the expiration date stamped on the carton.

• Executive Standard: Complies with the U.S. Food and Drug Administration (FDA) standards.

• Approval Number: FDA Approval No. 125486s029.

• Date of Revision: February 2022.

• Manufacturer: Genentech, a member of the Roche Group.

Guidelines for the Use of Obinutuzumab

• Dosage and Administration:

  • Recommended Dose:

    • CLL: Administer 100 mg intravenously on Day 1, 900 mg on Day 2, and 1,000 mg on Days 8 and 15 of Cycle 1. For Cycles 2 through 6, administer 1,000 mg on Day 1 of each cycle.

    • FL:

      • Relapsed/Refractory FL: Combine with bendamustine for six 28-day cycles, followed by monotherapy.

      • Previously Untreated FL: Combine with chemotherapy (e.g., CHOP or CVP) followed by monotherapy in patients achieving at least a partial remission.

  • Administration: Administer as an intravenous infusion. Premedication may be required to reduce the risk of infusion-related reactions.

  • Missed Dose:​ If a dose is missed, administer as soon as possible. Do not administer two doses on the same day.

• Adverse Reactions:

  • Common Adverse Reactions: Infusion-related reactions, fatigue, neutropenia, cough, upper respiratory tract infections, musculoskeletal pain.

  • Serious Adverse Reactions: Progressive multifocal leukoencephalopathy (PML), hepatitis B virus reactivation, severe infusion-related reactions, infections.

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• Contraindications:

  • Hypersensitivity to it or any of its components.

  • Active hepatitis B infection.

  • Severe active infections.

• Precautions:

  • Monitor for infusion-related reactions during and after administration.

  • Screen for hepatitis B virus infection prior to treatment.

  • Use with caution in patients with a history of cardiovascular disease.

Obinutuzumab Interactions

• Immunosuppressive Agents: Concurrent use may increase the risk of infections and neutropenia.

• Vaccines: Avoid live vaccines during treatment.

• Other Antineoplastic Agents: Use with caution due to potential additive immunosuppressive effects.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.