decreased blood cortisol, decreased blood testosterone, decreased blood gonadotophin, decreased thyroxine, cytokine release syndrome and hair colour changes. Serious Adverse Reactions Reported in Other Clinical Trials The following serious adverse reactions were also reported in patients with advanced melanoma treated with YERVOY in clinical studies (regardless of dose or regimen). Adverse reactions presented elsewhere in the ADVERSE REACTIONS section are excluded. Infections and infestations septic shock Uncommon: respiratory tract infection Rare: Blood and lymphatic system disorders anaemia Uncommon: polycythemia Rare: Immune System Disorders infusion related reaction Uncommon: hypersensitivity, sarcoidosis Rare: anaphylactic reaction (shock) Very Rare: Endocrine disorders secondary adrenocortical insufficiency, hyperpituitarism, autoimmune thyroiditis Rare: Metabolism and nutrition disorders dehydration Common: hypophosphatemia, Uncommon: alkalosis, tumour lysis syndrome Rare: Psychiatric disorders confusional state, mental status change Rare: Nervous system disorders ataxia, dysarthria. Uncommon: GuillainBarré syndrome, meningism, autoimmune central neuropathy (encephalitis) Rare: Eye disorders episcleritis, scleritis, iritis, eye oedema, ocular myositis Rare: Ear and labyrinth disorders neurosensory hypoacusis Rare: Cardiac disorders myocarditis, cardiomyopathy, pericardial effusion (pericarditis) Rare: Vascular disorders angiopathy, peripheral ischemia, vasculitis, temporal arteritis, Raynaud’s phenomenon, Rare:
decreased blood cortisol, decreased blood testosterone, decreased blood gonadotophin, decreased thyroxine, cytokine release syndrome and hair colour changes. Serious Adverse Reactions Reported in Other Clinical Trials The following serious adverse reactions were also reported in patients with advanced melanoma treated with YERVOY in clinical studies (regardless of dose or regimen). Adverse reactions presented elsewhere in the ADVERSE REACTIONS section are excluded. Infections and infestations Uncommon: septic shock Rare: respiratory tract infection Blood and lymphatic system disorders Uncommon: anaemia Rare: polycythemia Immune System Disorders Uncommon: infusion related reaction Rare: hypersensitivity, sarcoidosis Very Rare: anaphylactic reaction (shock) Endocrine disorders Rare: secondary adrenocortical insufficiency, hyperpituitarism, autoimmune thyroiditis Metabolism and nutrition disorders Common: dehydration Uncommon: hypophosphatemia, Rare: alkalosis, tumour lysis syndrome Psychiatric disorders Rare: confusional state, mental status change Nervous system disorders Uncommon: ataxia, dysarthria. Rare: GuillainBarré syndrome, meningism, autoimmune central neuropathy (encephalitis) Eye disorders Rare: episcleritis, scleritis, iritis, eye oedema, ocular myositis Ear and labyrinth disorders Rare: neurosensory hypoacusis Cardiac disorders Rare: myocarditis, cardiomyopathy, pericardial effusion (pericarditis) Vascular disorders Rare: angiopathy, peripheral ischemia, vasculitis, temporal arteritis, Raynaud’s phenomenon,
auspar-ipilimumab-rch-170206-pi.docx