Electronicjuice Vol 264 No 7090p522
April 1, 2000 Products
Composition: 403mg sevelamer.
Presentation: Hard, white capsules.
Storage and stability: Do not store above 25C. Keep container tightly closed.
Action: Non-absorbed phosphate binder.
Indications: Control of hyperphosphataemia in adult patients on haemodialysis. Use within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues, to control the development of renal bone disease.
Contraindications: Hypophosphataemia; bowel obstruction; hypersensitivity to sevelamer or any of the excipients.
Dosage and administration: Adults and elderly over 65 years, for patients not on phosphate binders dosage is determined individually, based on serum phosphate concentration (see SPC for details). If prescribed as an alternative phosphate binder, sevelamer should be given in doses equivalent to previous calcium-based phosphate binder. Serum phosphate levels should be closely monitored and the dose adjusted accordingly with the aim of lowering serum phosphate to 1.94mmol/L or less. Serum phosphate should be tested every two to three weeks until a stable serum phosphate level is reached, and on a regular basis thereafter. The dose range may vary between one and 10 capsules per meal. Sevelamer should be taken with meals and patients should adhere to their prescribed diets. The capsules must be swallowed whole.
Children under 18 years, safety and efficacy not established.
Pregnancy and lactation, safety not established, see SPC.
Precautions: Efficacy and safety has not been studied in predialysis patients or those receiving peritoneal dialysis treatment. Sevelamer should only be used in the following patients after careful assessment of benefit and risks: patients with swallowing disorders, untreated or severe gastroparesis, or retention of gastric contents. Use with caution in patients with active inflammatory bowel disease, gastrointestinal motility disorders, abnormal or irregular bowel motion or a history of major gastrointestinal disease. Serum chloride may increase during treatment and should be monitored.
Drug interactions: Interaction studies have not been conducted in patients on haemodialysis.
Side effects: In uncontrolled studies, effects in 10 per cent or more of patients included: pain, diarrhoea, nausea, vomiting, dyspepsia, constipation, infection, headache, respiratory disorder, cough, hypotension, dizziness, dyspnoea, thrombosis, peripheral oedema, accidental injury, chest pain, abdominal pain, fever, leg cramps, hypertension and pruritus. In 1-10 per cent of patients: cardiovascular disorder, pharyngitis and rash. All these effects are commonly seen in patients with end stage renal failure and are not necessarily attributed to sevelamer.
Net price: 200 capsules £73.
Supplier: Genzyme Therapeutics, 37 Hollands Road, Haverhill, Suffolk CB9 8PU. Tel 01440 716405, fax, 01440 714392.
Legal class: POM.
Citation: Electronicjuice URI: 20001060
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