precipitating factors, in patients taking etanercept. There have also been rare ( onset CHF, including CHF in patients without known pre-existing cardiovascular disease. Some of these patients have been under 50 years of age. Two large clinical trials evaluating the use of etanercept in the treatment of CHF were terminated early due to lack of efficacy. Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to etanercept treatment.
Alcoholic hepatitis In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with etanercept or placebo for moderate to severe alcoholic hepatitis, etanercept was not efficacious, and the mortality rate in patients treated with etanercept was significantly higher after 6 months. Consequently, Erelzi should not be used in patients for the treatment of alcoholic hepatitis. Physicians should use caution when using Erelzi in patients who also have moderate to severe alcoholic hepatitis.
Wegener's granulomatosis A placebo-controlled trial, in which 89 adult patients were treated with etanercept in addition to standard therapy (including cyclophosphamide or methotrexate, and glucocorticoids) for a median duration of 25 months, has not shown etanercept to be an effective treatment for Wegener’s granulomatosis. The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with etanercept than in the control group. Erelzi is not recommended for the treatment of Wegener’s granulomatosis.
Hypoglycaemia in patients treated for diabetes There have been reports of hypoglycaemia following initiation of etanercept in patients receiving medicinal product for diabetes, necessitating a reduction in anti-diabetic medicinal products in some of these patients. Special populations Elderly In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received etanercept were observed compared with younger patients.
However, caution should be exercised when treating the elderly and particular attention paid with respect to occurrence of infections. Paediatric population Vaccinations It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Erelzi therapy (see Vaccinations, above). Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per 25 mg or 50 mg, that is to say essentially ‘sodium-free’. 4.5 Interaction with other medicinal products and other forms of interaction Concurrent treatment with anakinra 9