Table 1: Summary of ongoing safety concerns Summary of safety concerns Important identified risks Malignancy (including lymphoma and leukaemia) Serious and opportunistic infections (including TB, Legionella, Listeria, parasitic infection) Lupus-like reactions Sarcoidosis and/or granulomas Injection site reactions Allergic reactions Severe cutaneous adverse reactions (including toxic epidermal necrolysis and Stevens-Johnson Syndrome) Systemic vasculitis (including ANCA positive vasculitis) Macrophage activation syndrome Central demyelinating disorders Peripheral demyelinating events (CIDP and GBS) Aplastic anaemia and pancytopenia Interstitial lung disease (including pulmonary fibrosis and pneumonitis) Autoimmune hepatitis events in patients with history of viral hepatitis (including hepatitis B virus reactivation) Important identified risks Change in morphology and/or severity of psoriasis – specific indications Worsening of CHF in adult subjects Important potential risks all Autoimmune renal disease – indications Pemphigus/pemphigoid Amyotrophic lateral sclerosis Myasthenia gravis Encephalitis/leukoencephalomyelitis Progressive multifocal leukoencephalopathy Liver failure Hepatic cirrhosis and fibrosis Severe hypertensive reactions Adverse pregnancy outcomes
Table 1: Summary of ongoing safety concerns Summary of safety concerns Important identified risks Malignancy (including lymphoma and leukaemia) Serious and opportunistic infections (including TB, Legionella, Listeria, parasitic infection) Lupus-like reactions Sarcoidosis and/or granulomas Injection site reactions Allergic reactions Severe cutaneous adverse reactions (including toxic epidermal necrolysis and Stevens-Johnson Syndrome) Systemic vasculitis (including ANCA positive vasculitis) Macrophage activation syndrome Central demyelinating disorders Peripheral demyelinating events (CIDP and GBS) Aplastic anaemia and pancytopenia Interstitial lung disease (including pulmonary fibrosis and pneumonitis) Autoimmune hepatitis events in patients with history of viral hepatitis (including hepatitis B virus reactivation) Important identified risks – specific indications Change in morphology and/or severity of psoriasis Worsening of CHF in adult subjects Important potential risks – all indications Autoimmune renal disease Pemphigus/pemphigoid Amyotrophic lateral sclerosis Myasthenia gravis Encephalitis/leukoencephalomyelitis Progressive multifocal leukoencephalopathy Liver failure Hepatic cirrhosis and fibrosis Severe hypertensive reactions Adverse pregnancy outcomes
auspar-etanercept-rch.docx