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
Rheumatoid Arthritis From a 100 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal to the volume of the ACTEMRA solution required for the patient’s dose, and discard. Withdraw the required amount of ACTEMRA (0.4 mL per kg of the patient’s body weight) under aseptic conditions and add to the infusion bag. To mix the solution, gently invert the bag to avoid foaming. pJIA and sJIA patients ≥ 30 kg From a 100 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal to the volume of the ACTEMRA solution required for the patient’s dose. Withdraw the required amount of ACTEMRA (0.4 mL per kg of the patient’s body weight) under aseptic conditions and dilute in a 100 mL infusion bag containing sterile, non-pyrogenic 0.9% sodium chloride solution. To mix the solution, gently invert the bag to avoid foaming. pJIA patients < 30 kg From a 50 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal to 0.5 mL/kg of the patient’s body weight and discard. This volume should be replaced in the saline bag with an equal volume of ACTEMRA under aseptic conditions. To mix the solution, gently invert the bag to avoid foaming. sJIA patients < 30 kg From a 50 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal to 0.6 mL/kg of the patient’s body weight and discard. This volume should be replaced in the saline bag with an equal volume of ACTEMRA under aseptic conditions. To mix the solution, gently invert the bag to avoid foaming. OVERDOSAGE are limited data available on overdosage with ACTEMRA. One case of accidental overdose was reported in which a patient with multiple myeloma received a single dose of 40 mg/kg. No adverse drug reactions were observed. No serious adverse drug reactions were observed in healthy volunteers who received a single dose up to 28 mg/kg, although dose-limiting neutropenia was observed. Treatment of overdose should consist of general supportive measures. For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia). PRESENTATION AND STORAGE ACTEMRA is available as: *(not marketed)