Sevelamer Hydrochloride

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Sevelamer Hydrochloride is indicated for the reduction of serum phosphorus in patients with end-stage renal disease (ESRD).

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Sevelamer is contraindicated in patients with hypophosphatemia or bowel obstruction and in patients with known hypersensitivity to Sevelamer hydrochloride or any of its constituents.

Sevelamer Hydrochloride is a new treatment for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Elevated serum phosphorus levels or uncontrolled hyperphosphatemia leads to development of secondary hyperparathyroidism, renal bone disease, calcification of vascular and nonvascular tissues, and cardiovascular disease. It is a calcium-free and aluminium-free nonabsorbed polymer phosphate binder, it does not cause calcium and aluminium toxicity. When taken with meals it inhibits intestinal absorption of ingested phosphate.

Sevelamer has been studied in human drug-drug interaction studies with ciprofloxacin, digoxin, warfarin, enalapril, metoprolol and iron.

Sevelamer may cause dyspepsia, peritonitis, diarrhea, nausea, constipation, pruritus, abdominal distension, vomiting, fatigue, anorexia, arthralgia and less commonly ileus, bowel obstruction and bowel perforation.

Over dosages of Sevelamer in patients was never reported. Since Sevelamer is not absorbed, the risk of systemic toxicity is low.

Pregnancy Category C. No adequate and controlled studies have been conducted using Sevelamer in nursing mothers. Sevelamer should be used during breastfeeding only if the potential benefit justifies the potential risks.

The safety and efficacy of Sevelamer in patients with dysphagia, swallowing disorders, severe GI motility disorders including severe constipation, or major GI tract surgery have not been established. Caution should be exercised when Sevelamer is used in patients with these GI disorders.