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obinutuzumab (Gazyva)

Indications: - treatment-naive patients with chronic lymphocytic leukemia - for use with chlorambucil - 1st line treatment of follicular lymphoma [2] - lupus nephritis: for use with mycophenolate & glucocorticoid [4] Adverse effects: - infusion-related reactions - neutropenia - thrombocytopenia - anemia - musculoskeletal pain, mylagias, bone pain - fever - nausea [2] - associated with severe COVID-19 infection [3] - boxed warning - potential risks for hepatitis B virus reactivation & progressive multifocal leukoencephalopathy Mechanism of action: - humanized type II anti-CD20 monoclonal antibody

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

General

antineoplastic monoclonal antibody

References

  1. FDA News Release: Nov. 1, 2013 FDA approves Gazyva for chronic lymphocytic leukemia http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm373209.htm
  2. Marcus R, Davies A, Ando K et al Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med 2017; 377:1331-1344. October 5, 2017 PMID: 28976863 http://www.nejm.org/doi/full/10.1056/NEJMoa1614598
  3. Ingram I Anti-CD20 Drugs Tied to Severe COVID in Cancer Patients - Plus: Active chemo treatment may not be a COVID risk factor. MedPage Today February 5, 2021 https://www.medpagetoday.com/hematologyoncology/lymphoma/91092
  4. Monaco K Obinutuzumab for Lupus Nephritis Boosts Complete Remissions. Positive phase III data being shared with FDA. MedPage Today. February 7, 2025 https://www.medpagetoday.com/rheumatology/lupus/114139 - Furie RA et al Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. N Engl J Med. 2025. Feb 7. Not yet indexed in PubMed https://www.nejm.org/doi/full/10.1056/NEJMoa2410965