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Information about Nivolumab

Nivolumab is a human monoclonal antibody to programmed cell death receptor 1 (PD-1), which modulates T cell immune reactivity and is used in the immunotherapy of cancer. 

Liver safety of Nivolumab

Nivolumab has major side effects and particularly immune related conditions, including acute liver injury which can be serious and even life threatening. 

Mechanism of action of Nivolumab

Nivolumab (nye vol' ue mab) is a human recombinant monoclonal immunoglobulin G4 antibody to the programmed cell death receptor-1 (PD-1) which has distinctive immunomodulatory activity and is used in cancer immunotherapy.  PD-1 is an important check point molecule that modulates and down regulates T cell responses.  Inhibition of PD-1 receptors on the surface of activated T cells prevents their binding to the costimulatory factor B7 and consequently allows for a continued activation and proliferation of T cells.  The subsequent enhancement of cytotoxic reactivity may play a beneficial role in cancer immunotherapy by breaking immunological tolerance to cancer cell associated antigens.  In several large multicenter studies, nivolumab therapy resulted in a prolongation of survival in patients with advanced, metastatic or unresectable malignant melanoma, and a proportion of patients had a long term remission. 

FDA approval information for Nivolumab

Nivolumab was approved for use in advanced melanoma in the United States in 2015 and is under active investigation in several other forms of cancer, including renal, breast and colon cancer.  Nivolumab is available in liquid solution in 40 and 100 mg vials (10 mg/mL) under the brand name Opdivo.  The typical regimen is 3 mg/kg as an intravenous infusion every 2 weeks.  In 2015, the combination of nivolumab with ipilimumab, a monoclonal antibody to CTLA-4, another check point molecule, was approved as combination immunotherapy for malignant melanoma

Side effects of Nivolumab

Side effects of nivolumab are common and can be severe.  As many as half of treated patients develop immune related side effects as a result of immune enhancement including enterocolitis, dermatitis, endocrinopathy, pneumonitis, neuropathy, nephritis and hepatitis.  Most of these reactions respond to immunosuppressive therapy, but some have resulted in fatalities and some have required long term therapy.  Early recognition and prompt management of these side effects is an integral component of proper use of nivolumab and other check point inhibitors such as ipilimumab and pembrolizumab.


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