Nivolumab Disease Interactions

Immune-mediated colitis has been reported with the use of nivolumab. Monitor patients for signs and symptoms of colitis. It is recommended to administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents followed by corticosteroid taper for severe or life-threatening colitis. Administer corticosteroids at a dose of 0.5 to 1 mg/kg/day prednisone equivalents followed by corticosteroid taper for moderate colitis of more than 5 days duration; if worsening or no improvement occurs despite initiation of corticosteroids, increase dose to 1 to 2 mg/kg/day prednisone equivalents. If appropriate modify the dose according to manufacturer recommendations when nivolumab is administered in combination with ipilimumab, and if nivolumab is withheld, ipilimumab should also be withheld. Permanently discontinue nivolumab and ipilimumab for life-threatening or for recurrent colitis. Care should be taken when using nivolumab in patients with inflammatory bowel disease.

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Nivolumab can cause type 1 diabetes mellitus. Monitor for hyperglycemia or other signs and symptoms of diabetes. Withhold treatment in cases of severe hyperglycemia until metabolic control is achieved. Permanently discontinue nivolumab for life-threatening hyperglycemia. If appropriate modify the dose according to manufacturer recommendations when nivolumab is administered in combination with ipilimumab, and if nivolumab is withheld, ipilimumab should also be withheld. Care should be exercised when using nivolumab in diabetic patients.

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Nivolumab can cause immune-mediated hepatitis. Based on a population pharmacokinetic analysis, no dose adjustment is recommended for patients with mild or moderate hepatic impairment. Caution is recommended when using nivolumab in patients with severe hepatic impairment as this agent has not been studied in these patients. Monitor patients for abnormal liver tests prior to and periodically during treatment. It is recommended to administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents followed by corticosteroid taper for severe or life-threatening transaminase elevations, with or without concomitant elevation in total bilirubin. Administer corticosteroids at a dose of 0.5 to 1 mg/kg/day prednisone equivalents for moderate transaminase elevations. If appropriate modify the dose according to manufacturer recommendations when nivolumab is administered in combination with ipilimumab, and if nivolumab is withheld, ipilimumab should also be withheld. Care should be taken when using nivolumab in patients with liver disease.

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Nivolumab can cause immune-mediated encephalitis with no clear alternate etiology. It is recommended to evaluate patients with neurologic symptoms with consultation with a neurologist, brain MRI, lumbar puncture, and as clinically indicated. Withhold nivolumab in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out infectious or other causes of moderate to severe neurologic deterioration. If other etiologies are ruled out, administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents for patients with immune-mediated encephalitis, followed by corticosteroid taper. Permanently discontinue nivolumab for immune-mediated encephalitis. If appropriate modify the dose according to manufacturer recommendations when nivolumab is administered in combination with ipilimumab, and if nivolumab is withheld, ipilimumab should also be withheld. Care should be taken when using nivolumab in patients with neurologic disorders.

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Immune-mediated pneumonitis, including fatal cases have been reported with the use of nivolumab. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. It is recommended to administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents for moderate or more severe pneumonitis, followed by corticosteroid taper. Permanently discontinue therapy for severe or life-threatening pneumonitis and withhold therapy until resolution for moderate pneumonitis. If appropriate modify the dose according to manufacturer recommendations when nivolumab is administered in combination with ipilimumab, and if nivolumab is withheld, ipilimumab should also be withheld. Care should be taken when using nivolumab in patients with pulmonary infections.

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Nivolumab can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. It is recommended to administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents followed by corticosteroid taper for life-threatening increased serum creatinine. Administer corticosteroids at a dose of 0.5 to 1 mg/kg/day prednisone equivalents for moderate or severe increased serum creatinine, if worsening or no improvement occurs, increase dose of corticosteroids to 1 to 2 mg/kg/day prednisone equivalents. Withhold nivolumab for moderate or severe increased serum creatinine. Permanently discontinue nivolumab for life-threatening increased serum creatinine. If appropriate modify the dose according to manufacturer recommendations when nivolumab is administered in combination with ipilimumab, and if nivolumab is withheld, ipilimumab should also be withheld. Care should be taken when using nivolumab in patients with renal dysfunction.

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Nivolumab can cause autoimmune thyroid disorders. Monitor thyroid function prior to and periodically during treatment. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. There are no recommended dose adjustments of nivolumab for hypothyroidism or hyperthyroidism. Care should be taken when using this agent in patients with thyroid disease.

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Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. It is recommended to follow patients closely for evidence of transplant-related complications and intervene promptly. The benefit versus risks of treatment with a PD-1/PD-L1 blocking antibody before or after an allogeneic HSCT should be considered.

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Myasthenic syndrome/myasthenia gravis (including exacerbation) has been reported with the use of programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibodies. Care should be exercised when using PD-1/PD-L1 blocking antibodies in patients with myasthenia gravis.

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Solid organ transplant rejection and other transplant (including corneal graft) rejection have been reported with the use of programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibodies. Care should be exercised when using PD-1/PD-L1 blocking antibodies in patients who have received a solid organ or other transplant.

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