Do not administer as IV push or bolus inj. Monitor patients for signs & symptoms of immune-related adverse reactions eg, pneumonitis, colitis, hepatitis, endocrinopathies (including hypothyroidism, hyperthyroidism, thyroiditis, hypophysitis, type 1 DM & adrenal insufficiency), nephritis, rash (including pemphigoid), arthralgia. Clinical chemistries, including renal, liver & thyroid function tests, should be evaluated at baseline & periodically during treatment. Permanently discontinue treatment for any Grade 3 immune-related adverse reaction that recurs & for any Grade 4 immune-related adverse reaction toxicity, except for endocrinopathies that are controlled w/ replacement hormones. Risk of SJS or TEN. Caution in patients who previously experienced severe or life-threatening skin adverse reaction on prior treatment w/ other immune-stimulatory anticancer agents. Risk of other immune-related adverse reactions eg, myositis, myocarditis, encephalitis, demyelinating neuropathy (including Guillain Barré syndrome), sarcoidosis; autoimmune haemolytic anaemia, pancreatitis, iridocyclitis, uveitis, diabetic ketoacidosis. May increase the risk of rejection in solid organ transplant recipients. Fatal & other serious complications can occur in patients who receive allogeneic haematopoietic stem cell transplantation. Can cause infusion-related reactions. Stop infusion & permanently discontinue treatment for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Patients w/ ECOG baseline performance score ≥2; uncontrolled CNS metastases or carcinomatous meningitis; other malignancies w/in the last 2 yr; immunodeficiency or receiving immunosuppressive therapy w/in 7 days; active HIV, hepatitis B or hepatitis C infection; active autoimmune disease requiring systemic treatment in the past 2 yr excluding replacement therapy; history of ILD; receiving live vaccine w/in 14 days; severe renal impairment or ESRD undergoing dialysis; moderate or severe hepatic impairment. Not recommended during pregnancy & in women of childbearing potential not using contraception. Women of childbearing potential must use effective contraception during treatment & until 4 mth after the last dose. Do not use during breast-feeding & avoid breast-feeding for at least 4 mth after the last dose. Elderly ≥75 yr. Childn & adolescents <18 yr.
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