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, diabetic ketoacidosis & adrenal insufficiency), nephritis, rash (including pemphigoid), arthralgia. Evaluate haematological & clinical chemistries, including liver, kidney & thyroid function tests, 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. 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 excluded from GARNET study (monotherapy): 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 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. Patients excluded from RUBY study (combination therapy): concomitant malignancy, or prior non-endometrial invasive malignancy (disease-free for <3 yr or received any active treatment in the last 3 yr for that malignancy); uncontrolled CNS metastases or carcinomatous meningitis, or both; known history of HIV or active hepatitis B or C; immunodeficiency or receiving immunosuppressive therapy w/in 7 days; considered poor medical risk due to serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy; receiving live vaccine w/in 30 days before 1st dose of study treatment, during study treatment, & for up to 180 days after receiving the last dose of study treatment. Limited data in patients w/ severe renal impairment or ESRD undergoing dialysis; moderate hepatic impairment. No data in patients w/ 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. Safety & efficacy in childn & adolescents <18 yr have not been established. Limited clinical data in elderly ≥75 yr.
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