ROXUDO

*Symptomatic anaemia associated with chronic kidney disease in patients not currently treated with an erythropoiesis-stimulating agent (initiated by a specialist):* Adult (body-weight up to 100 kg): Initially 70 mg 3 times a week, adjusted according to response; usual maintenance 20-400 mg 3 times a week, dose adjusted at intervals of 4 weeks to achieve haemoglobin concentration of 10 to 12 g/dL. Discontinuation treatment if adequate increase in haemoglobin concentration not achieved in 24 weeks. Adult (body-weight 100 kg and above): Initially 100 mg 3 times a week, adjusted according to response; usual maintenance 20-400 mg 3 times a week, dose adjusted at intervals of 4 weeks to achieve haemoglobin concentration of 10 to 12 g/dL. Discontinuation treatment if adequate increase in haemoglobin concentration not achieved in 24 weeks. *Symptomatic anaemia associated with chronic kidney disease in patients currently treated with an erythropoiesis-stimulating agent (initiated by a specialist):* Adult: (consult product literature).

Active infection. history of seizures, epilepsy and other medical conditions associated with a predisposition to seizures. risk factors for venous thromboembolism. Caution in moderate hepatic impairment; use half the normal starting dose, avoid in severe impairment. Pre-treatment screening: Ensure adequate iron stores before treatment. Monitor haemoglobin concentration every 2 weeks until the desired haemoglobin concentration is achieved and stabilised, then every 4 weeks thereafter or as clinically indicated.

Drugs highly bound to red cells e.g. Cyclosporin.

Constipation, diarrhoea, embolism and thrombosis, headache, hyperkalaemia, hypertension, insomnia, nausea, peripheral oedema, seizure, sepsis, increased risk of infection, vomiting. Rare: Hyperbilirubinaemia.