(N = 1380) (%) (N =690) (%) Infections and infestations respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral) 39 33 oral infections (including herpes simplex, oral herpes and tooth infections) 7 5 reproductive infections (including vulvovaginal mycotic infection) 3 1 and the lymphatic system disorders anaemia 13 8 leucopaenia (including neutropaenia and agranulocytosis) 14 8 leucocystosis 1 0 thrombocytopenia 1 0 Metabolism and nutrition disorders lipids increased 17 8 uric acid increased 6 3 blood sodium abnormal 10 3 hypokalaemia 3 2 hypophosphotaemia 2 1 blood potassium increased 3 1 Nervous system disorders headache 14 8 Vascular disorders hypertension 6 3 flushing 2 1 Respiratory, thoracic and mediastinal disorders cough 7 6 Gastrointestinal disorders nausea and vomiting 12 11 abdominal pain 10 6 sicca syndrome 3 2 GI haemorrhage 2 1 Hepato-biliary disorders liver enzymes elevated 12 8 Skin and subcutaneous tissue disorders rash (including exfoliative rash) 14 7 pruritus 5 1 dermatitis (including eczema) 3 1 bruising (including purpura) 2 0 Musculoskeletal, connective tissue and bone disorders musculoskeletal pain 14 9 muscle spasms (including creatine phosphokinase increased) 5 4 Renal and urinary disorders haematuria 9 4 renal impairment 8 4
DOSAGE AND ADMINISTRATION Humira is administered by subcutaneous injection. This product is for one dose in one patient only. Rheumatoid Arthritis The recommended dose of Humira for adult patients with rheumatoid arthritis is 40 mg administered fortnightly as a single dose. Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs or analgesics may be continued during treatment with Humira. Some patients not taking concomitant methotrexate may derive additional benefit from increasing the dosing frequency of Humira to 40 mg week. Juvenile Idiopathic Arthritis The recommended dose of Humira for patients 2 years of age and older with polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis is based on weight as shown in the table below. Methotrexate, glucocorticoids, NSAIDs and/or analgesics may be continued during treatment with Humira. Paediatric Patients (2 years of age and older) Dose 10 kg to <15 kg 10 mg fortnightly (10 mg Pre-filled Syringe) 15 kg to <30 kg 20 mg fortnightly (20 mg Pre-filled Syringe) ≥ 30 kg 40 mg fortnightly (Humira 40 mg Pen or 40 mg Pre-filled Syringe) Available data suggest that a clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period. Humira has not been studied in patients with JIA less than 2 of age, or in patients with a weight below 10 kg. Humira has not been studied in patients with enthesitis-related arthritis aged less than 6 years or any child weighing less than 10kg. Psoriatic Arthritis The recommended dose of Humira for patients with psoriatic arthritis is 40 mg adalimumab administered fortnightly as a single dose. Glucocorticoids, salicylates, nonsteroidal anti−inflammatory analgesics or disease-modifying drugs can be continued during treatment with Humira.