Do not administer as IV push or single bolus inj. Withhold treatment for the following immune-related adverse reactions: grade 2 pneumonitis; hepatitis (ALT or AST >3 to 8 x ULN or total bilirubin >1.5 to 3 x ULN); grade 3 rash; suspected severe cutaneous adverse reactions (SCARs), including SJS or TEN; grade 2 or 3 colitis; grade 2 or 3 myositis/rhabdomyolysis; grade 3 or 4 hyperthyroidism; grade 3 or 4 adrenal insufficiency; grade 3 or 4 hypophysitis; type 1 DM associated w/ grade ≥3 hyperglycaemia (glucose >250 mg/dL or >13.9 mmol/L) or associated w/ ketoacidosis; grade 2 nephritis w/ renal dysfunction (creatinine >1.5 to 3 x baseline or >1.5 to 3 x ULN); grade 2 neurological toxicities; grade 3 pancreatitis, or grade 3 or 4 serum amylase or lipase levels increased (>2 x ULN). Permanently discontinue treatment for the following immune-related adverse reactions: grade 3 or 4, or recurrent grade 2 pneumonitis; hepatitis (ALT or AST >8 x ULN or total bilirubin >3 x ULN); grade 4 rash; confirmed SCARs, including SJS or TEN; grade 4 or recurrent grade 3 colitis; grade 4 or recurrent grade 3 myositis/rhabdomyolysis; grade 3 (creatinine >3 x baseline or >3 to 6 x ULN) or 4 (creatinine >6 x ULN) nephritis w/ renal dysfunction; grade 2, 3 or 4 myocarditis; grade 3 or 4 neurological toxicities; grade 4 pancreatitis. Consider withholding treatment for the following immune-related adverse reactions until controlled by HRT: grade 2 adrenal insufficiency; grade 2 hypophysitis. Grade 2, 3 or 4 immune-related hypothyroidism may be managed w/ HRT w/o treatment interruption. Reports of other clinically important immune-related adverse reactions: myositis, myocarditis, arthritis, polymyalgia rheumatica, pericarditis, Guillain-Barré syndrome. Increased risk of rejection in solid organ transplant recipients. Withhold treatment for other grade 3 immune-related adverse reactions. Permanently discontinue treatment for other grade 4 or recurrent grade 3 immune-related adverse reactions. Reports of severe infusion-related reactions. Consider pre-medication for grade 1 infusion-related reactions. Interrupt infusion for grade 2 infusion-related reactions. Permanently discontinue treatment for grade 3 or 4 infusion-related reactions. Do not mix or co-administer other medicinal products through the same infusion line. Caution in patient populations excluded from clinical studies: baseline ECOG performance score ≥2; active brain or leptomeningeal metastases; active autoimmune disease or history of autoimmune disease that may relapse; any condition requiring systemic treatment w/ either corticosteroids (>10 mg/day prednisone or equiv) or other immunosuppressants w/in 14 days prior to study treatment; active or untreated HIV; untreated hepatitis B or C carriers; history of ILD; administration of live vaccine w/in 14 days prior to study treatment; infection requiring systemic therapy w/in 14 days prior to study treatment; history of severe hypersensitivity to another monoclonal Ab. Contains 16 mg Na per 10 mL vial. Caution in patients on controlled Na diet. Minor influence on the ability to drive & use machines. Caution in patients w/ severe renal impairment; severe hepatic impairment. Women of childbearing potential should use effective contraception during treatment & for at least 4 mth following the last dose. Can cause foetal harm when administered to a pregnant woman. Do not use during pregnancy unless the clinical condition of the woman requires treatment. Do not breast-feed during treatment & for at least 4 mth after the last dose. Safety & efficacy in patients <18 yr have not been established.
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