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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].

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Last Update: May 1, 2016.



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


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 checkpoint 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. 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 checkpoint molecule, was approved as combination immunotherapy for malignant melanoma. 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 checkpoint inhibitors such as ipilimumab and pembrolizumab.


Mild-to-moderate serum aminotransferase elevations are not uncommon (~10%) during nivolumab therapy, but are usually self-limited and resolve even with continuing cyclic therapy. Serum ALT elevations above 5 times the upper limit of normal (ULN) occur in 0.5% to 1.5% of patients, and a proportion of these individuals develop clinically apparent liver injury that can be severe. The onset of such injury is usually after 2 to 6 cycles, 1 to 3 months after initiation of treatment. The pattern of enzyme elevation is usually hepatocellular but can be mixed, particularly at the onset. Liver histology demonstrates an acute hepatitis-like pattern with focal or confluent necrosis and prominent lymphocytic infiltrates of activated T cells, which is compatible with an immune mediated hepatic injury. However, autoantibodies are usually not present. Restarting nivolumab can result in recurrence of injury, although corticosteroid treatment may block recurrence.

The effects of PD-1 inhibition on hepatitis B have not been reported as enrollment criteria in the clinical trials of nivolumab have usually excluded patients with chronic viral hepatitis. However, it is possible that anti-PD-1 treatment would exacerbate chronic hepatitis B by enhancing T cell cytotoxicity to viral antigens, and such patients should be monitored during therapy and managed appropriately with antiviral therapy if necessary. In contrast, checkpoint immunotherapy in patients with hepatitis C has not been found to be deleterious and in some cases resulted in a decrease in HCV RNA levels.

Likelihood score: E* (although no specific cases have been described in the literature, this is a relatively recently approved medication and is likely to be a rare cause of clinically apparent acute liver injury).

Mechanism of Injury

The mechanism of liver injury due to nivolumab is likely to be immunologically mediated and some cases have appeared to respond to corticosteroid or immunosuppressive therapy allowing for continuation or restarting of nivolumab therapy.

Outcome and Management

Guidelines for management of patients receiving nivolumab recommend monitoring of liver tests and use of corticosteroids for patients who develop serum aminotransferase elevations above 5 times the ULN, initiating therapy with high doses of intravenous methylprednisolone and switching to oral prednisone after 1 to 2 days, continuing tapering doses for at least 30 days. Most cases of hepatitis due to nivolumab resolve with prompt institution of immunosuppressive therapy. The few fatal cases that have been reported during immunotherapy with check point inhibitors occurred in patients who had other severe immune related adverse events (Stevens Johnson syndrome, capillary leak syndrome) or who had a delay in starting corticosteroid therapy. There is little information on the safety of restarting nivolumab or other checkpoint inhibitors after occurrence of clinically apparent liver injury from their use. In some situations, therapy can be restarted safely after resolution of an immune mediated adverse event, but in other situations immunosuppressive therapy is required to control the adverse event.

Drug Class: Antineoplastic Agents, Monoclonal Antibodies, Checkpoint Inhibitors



Nivolumab – Opdivo®


Antineoplastic Agents


Product labeling at DailyMed, National Library of Medicine, NIH


Nivolumab946414-94-4Monoclonal AntibodyNot Available


References updated: 01 May 2016

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