Common use of CLINICAL INFORMATION Clause in Contracts

CLINICAL INFORMATION. i. Prescribed indications Cinacalcet is indicated for : 1. The treatment of acute hypercalcaemia symptomatic with calcium between 2.85-3.00mmol/ L or biochemically severe hypercalcaemia calcium >3.0mmol/l due to Primary Hyperparathyroidism, when parathyroidectomy is contraindicated or not clinically appropriate , and will avoid the need for further admission to hospital. (NHSE commissioning policy) 2. The treatment of hypercalcaemia (Ca >3.0mm/l) in patients who are significantly symptomatic and awaiting surgery. ii. Dose & route of administration The usual dose of cinacalcet is between 30-60mg twice daily. The calcium lowering effect is substantially present within two to three weeks (85-90%) after initiating therapy with 30mg twice daily. In patients whose serum calcium is not adequately controlled, the dose may be increased to 90mg FOUR times daily. Cinacalcet should be taken with or after food, preferably at the same time each day. iii. Adverse effects The most frequently reported adverse events are nausea and vomiting, rash, hypersensitivity, dizziness and myalgia. Isolated cases of hypotension, worsening heart failure and arrhythmia also reported. iv. Monitoring Requirements Baseline biochemical monitoring will be undertaken by the specialist in addition to all ongoing routine blood monitoring as described as part of the diagnosis and management of the condition (unless specifically agreed with the GP) Serum calcium 1 week after initiation or dose adjustment. After maintenance dose has been established, levels should be measured every 6 months The aim of treatment is to maintain adj Ca at between 2.50 and 2.80 mmol/l. See section 4v for advice on action to be taken if calcium levels become abnormal