Applies to nivolumab: parenteral injection.

Side effects include:

Monotherapy in patients with unresectable or metastatic melanoma (incidence ≥10% and higher [by ≥5%] than with chemotherapy): Fatigue, musculoskeletal pain, elevated ALT or AST concentrations, hyponatremia, elevated alkaline phosphatase concentrations, rash, pruritus, cough, hyperkalemia, upper respiratory infection, elevated bilirubin concentrations, edema, vitiligo, erythema.

Monotherapy in patients with unresectable or metastatic melanoma (incidence ≥20% and higher [by ≥5%] than with ipilimumab): Fatigue, hyperglycemia, musculoskeletal pain, lymphopenia, elevated concentrations of lipase, cough, upper respiratory infection, arthralgia.

Combination therapy with ipilimumab in patients with unresectable or metastatic melanoma (incidence ≥20% and higher [by ≥5%] than with ipilimumab): Fatigue, elevated ALT or AST concentrations, diarrhea, hyperglycemia, rash, anemia, hyponatremia, nausea, elevated lipase or amylase concentrations, elevated alkaline phosphatase concentrations, pyrexia, lymphopenia, hypocalcemia, vomiting, decreased appetite, cough, elevated S_cr concentrations, dyspnea, upper respiratory infection, arthralgia.

Single-agent adjuvant therapy in patients with completely resected locally advanced or metastatic melanoma (incidence ≥10% and higher [by ≥5%] than with ipilimumab): Musculoskeletal pain, lymphopenia, upper respiratory infection, arthralgia, leukopenia, neutropenia.

Monotherapy in patients with metastatic NSCLC (incidence ≥10% and higher [by ≥5%] than with docetaxel): Cough, decreased appetite, elevated ALT or AST concentrations, elevated alkaline phosphatase concentrations, elevated S_cr concentrations, elevated TSH concentrations, pruritus.

Monotherapy in patients with metastatic SCLC (incidence ≥20%): Fatigue, decreased appetite, musculoskeletal pain, dyspnea, nausea, diarrhea, constipation, cough.

Monotherapy in patients with advanced renal cell carcinoma previously treated with antiangiogenic therapy (incidence >15% and higher [by ≥5%] than with everolimus): Hyponatremia, hyperkalemia, constipation, back pain, arthralgia, hypercalcemia, pruritus, upper respiratory infection.

Combination therapy with ipilimumab in patients with intermediate- or poor-risk, previously untreated, advanced renal cell carcinoma (incidence >15% and higher [by ≥5%] than with sunitinib): Rash, pruritus, pyrexia, elevated amylase concentrations.

Monotherapy in patients with cHL (incidence ≥10%): Upper respiratory infection, fatigue, leukopenia, neutropenia, thrombocytopenia, cough, elevated ALT or AST concentrations, diarrhea, lymphopenia, pyrexia, anemia, musculoskeletal pain, rash, elevated lipase or amylase concentrations, elevated alkaline phosphatase concentrations, hyponatremia, nausea, pruritus, vomiting, headache, abdominal pain, arthralgia, hypokalemia, elevated S_cr concentrations, hypocalcemia, hyperkalemia, dyspnea, constipation, hypomagnesemia, infusion-related reactions, pneumonia, hypothyroidism/thyroiditis, peripheral neuropathy, elevated bilirubin concentrations, nasal congestion.

Monotherapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (incidence ≥10% and higher than with chemotherapy): Cough, dyspnea, elevated alkaline phosphatase concentrations, elevated amylase concentrations, hypercalcemia, hyperkalemia, elevated TSH concentrations.

Monotherapy in patients with locally advanced or metastatic urothelial carcinoma (incidence ≥10%): Asthenia/fatigue/malaise, hyperglycemia, lymphopenia, hyponatremia, anemia, elevated S_cr concentrations, elevated alkaline phosphatase concentrations, musculoskeletal pain, hypocalcemia, elevated ALT or AST concentrations, decreased appetite, elevated lipase or amylase concentrations, nausea, hyperkalemia, cough, diarrhea, pyrexia, urinary tract infection, constipation, hypomagnesemia, rash, thrombocytopenia, thyroid disorders, dyspnea, abdominal pain, edema, pruritus, vomiting, leukopenia, arthralgia.

Monotherapy in patients with metastatic colorectal cancer with MSI-H or dMMR (incidence ≥10%): Fatigue, diarrhea, abdominal pain, nausea, musculoskeletal pain, vomiting, cough, pyrexia, rash, constipation, upper respiratory tract infection, arthralgia, hyperglycemia, pruritus, headache, decreased appetite, dizziness, edema, anemia, elevated alkaline phosphatase concentrations, lymphopenia, elevated ALT or AST concentrations, elevated lipase or amylase concentrations, hyponatremia, neutropenia, hypocalcemia, hypomagnesemia, thrombocytopenia, elevated bilirubin concentrations, hypokalemia, elevated S_cr concentrations, hyperkalemia.

Combination therapy with ipilimumab in patients with metastatic colorectal cancer with MSI-H or dMMR (incidence ≥10%): Fatigue, diarrhea, musculoskeletal pain, pyrexia, abdominal pain, pruritus, nausea, rash, decreased appetite, vomiting, cough, headache, constipation, arthralgia, hypothyroidism, dyspnea, insomnia, hyperthyroidism, dizziness, dry skin, decreased weight, anemia, elevated ALT or AST concentrations, elevated lipase or amylase concentrations, elevated alkaline phosphatase concentrations, hyponatremia, thrombocytopenia, elevated S_cr concentrations, lymphopenia, hyperkalemia, elevated bilirubin concentrations, hypomagnesemia, neutropenia, hypocalcemia, hypokalemia.

Monotherapy in patients with advanced hepatocellular carcinoma: Adverse effects generally similar to those observed in other malignancies except for higher incidence of elevated ALT, AST, and bilirubin concentrations.

For Healthcare Professionals

Applies to nivolumab: intravenous solution.

Dermatologic

Very common (10% or more): Rash (21%), pruritus (19%), vitiligo (11%), erythema (10%)

Frequency not reported: Exfoliative dermatitis, erythema multiforme, vitiligo, psoriasis, immune-mediated rash^[Ref]

Hepatic

Very common (10% or more): Elevated AST (28%), elevated alkaline phosphatase (22%), elevated ALT (16%)

Common (1% to 10%): Elevated total bilirubin, immune-mediated hepatitis

Frequency not reported: Increased amylase, increased lipase^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea or colitis (21%)

Common (1% to 10%): Immune-mediated colitis, nausea, vomiting

Frequency not reported: Immune-mediated pancreatitis^[Ref]

Respiratory

Very common (10% or more): Cough (17%), upper respiratory tract infection (17%)

Common (1% to 10%): Pneumonitis, immune-mediated pneumonitis, dyspnea^[Ref]

Renal

Very common (10% or more): Increased serum creatinine (13%)

Uncommon (0.1% to 1%): Immune-mediated nephritis, immune-mediated renal dysfunction^[Ref]

Cardiovascular

Very common (10% or more): Peripheral edema (10%)

Frequency not reported: Ventricular arrhythmia^[Ref]

General

The most commonly reported adverse reaction in clinical trials was rash; a composite term including the following rashes maculopapular, erythematous, pruritic, follicular, macular, papular, pustular, vesicular, and dermatitis acneiform.^[Ref]

Endocrine

Common (1% to 10%): Hypothyroidism, hyperthyroidism

Frequency not reported: Immune-mediated hypopituitarism, immune-mediated hypophysitis^[Ref]

Nervous system

Frequency not reported: Dizziness, peripheral and sensory neuropathy, immune-mediated demyelination, immune-mediated facial and abducens nerve paresis, immune-mediated myasthenic syndrome, immune-mediated encephalitis^[Ref]

Local

Frequency not reported: Infusion-related reactions^[Ref]

Ocular

Frequency not reported: Iridocyclitis^[Ref]

Metabolic

Very common (10% or more): Anorexia (28%)

Frequency not reported: Immune-mediated adrenal insufficiency, immune-mediated diabetic ketoacidosis^[Ref]

Immunologic

Frequency not reported: Immune-mediated uveitis, immune-mediated autoimmune neuropathy, immune-mediated Guillain-Barre Syndrome^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (32%), back pain (21%), arthralgia (20%)

Frequency not reported: Pain in extremity^[Ref]

Other

Very common (10% or more): Fatigue (49%)

Common (1% to 10%): Pyrexia^[Ref]