Upper Respiratory Tract 7 5 9 9 7 Infection Nasopharyngitis 7 6 5 7 5 Headache 7 2 6 6 4 Hypertension 6 2 6 5 3 Cough 3 0 3 3 2 ALT increased 6 4 3 3 1 Diarrhoea 5 5 5 4 4 Back Pain 2 1 3 4 3 Peripheral Oedema 2 0 2 3 1 Dizziness 3 1 2 3 2 Bronchitis 3 2 4 3 3 Rash 2 1 4 3 1 Mouth Ulceration 2 2 1 2 1 Abdominal Pain Upper 2 2 3 3 2 Gastritis 1 2 2 2 1 Transaminase increased 1 5 3 3 1 Other infrequent and medically relevant adverse events occurring at an incidence of less than 2% in rheumatoid arthritis patients treated with ACTEMRA in controlled trials were: cellulitis, oral herpes simplex, herpes zoster, diverticulitis Infections and infestations: stomatitis, gastric ulcer Gastrointestinal disorders: pruritus, urticaria Skin and subcutaneous tissue disorders: weight increased, total bilirubin increased Investigations: leucopenia, neutropenia and lymphaticsystem disorders: hypercholesterolaemia, hypertriglyceridaemia Metabolism and nutrition disorders: hypersensitivity reaction General disorders and administration site conditions: dyspnoea Respiratory, thoracic and mediastinal disorders: conjunctivitis Eye disorders: nephrolithiasis disorders: hypothyroidism Endocrine disorders: Infections In the 6 month controlled clinical trials, the rate of all infections reported with ACTEMRA 8 mg/kg + DMARD treatment was 127 events per 100 patient (pt) years compared to 112 events per 100 pt years in the placebo + DMARD group. In the all population the overall rate of infections with ACTEMRA was 108 events per exposure 100 pt years exposure. In the 6 month controlled clinical trials, the rate of serious infections (bacterial, viral and fungal) with ACTEMRA 8 mg/kg + DMARD was 5.3 events per 100 pt years exposure compared to 3.9 events per 100 pt years exposure in the placebo + DMARD group. In the monotherapy study the rate of serious infections was 3.6 events per 100 pt years of
Upper Respiratory Tract Infection 7 5 9 9 7 Nasopharyngitis 7 6 5 7 5 Headache 7 2 6 6 4 Hypertension 6 2 6 5 3 Cough 3 0 3 3 2 ALT increased 6 4 3 3 1 Diarrhoea 5 5 5 4 4 Back Pain 2 1 3 4 3 Peripheral Oedema 2 0 2 3 1 Dizziness 3 1 2 3 2 Bronchitis 3 2 4 3 3 Rash 2 1 4 3 1 Mouth Ulceration 2 2 1 2 1 Abdominal Pain Upper 2 2 3 3 2 Gastritis 1 2 2 2 1 Transaminase increased 1 5 3 3 1 Other infrequent and medically relevant adverse events occurring at an incidence of less than 2% in rheumatoid arthritis patients treated with ACTEMRA in controlled trials were: Infections and infestations: cellulitis, oral herpes simplex, herpes zoster, diverticulitis Gastrointestinal disorders: stomatitis, gastric ulcer Skin and subcutaneous tissue disorders: pruritus, urticaria Investigations: weight increased, total bilirubin increased and lymphaticsystem disorders: leucopenia, neutropenia Metabolism and nutrition disorders: hypercholesterolaemia, hypertriglyceridaemia General disorders and administration site conditions: hypersensitivity reaction Respiratory, thoracic and mediastinal disorders: dyspnoea Eye disorders: conjunctivitis disorders: nephrolithiasis Endocrine disorders: hypothyroidism Infections In the 6 month controlled clinical trials, the rate of all infections reported with ACTEMRA 8 mg/kg + DMARD treatment was 127 events per 100 patient (pt) years compared to 112 events per 100 pt years in the placebo + DMARD group. In the all exposure population the overall rate of infections with ACTEMRA was 108 events per 100 pt years exposure. In the 6 month controlled clinical trials, the rate of serious infections (bacterial, viral and fungal) with ACTEMRA 8 mg/kg + DMARD was 5.3 events per 100 pt years exposure compared to 3.9 events per 100 pt years exposure in the placebo + DMARD group. In the monotherapy study the rate of serious infections was 3.6 events per 100 pt years of
auspar-tocilizumab-150112-pi.docx