sevelamer hydrochloride: clinical use

Prescribing considerations

• Selected product licensing covers adults receiving haemodialysis or peritoneal dialysis; efficacy and safety are not established for predialysis use or people under 18.
• Use within comprehensive phosphate and renal bone-disease management rather than as sole treatment for hyperparathyroidism.
• Review swallowing ability, constipation and gastrointestinal history before and during treatment.
• Reassess treatment if severe constipation or other severe gastrointestinal symptoms develop.

Contraindications and cautions

• Hypersensitivity to sevelamer or an excipient
• Hypophosphataemia
• Bowel obstruction

Monitoring

• Serum phosphate and calcium
• Serum bicarbonate and chloride
• Vitamin A, D and E levels and vitamin K status where indicated; consider folate, particularly during peritoneal dialysis
• Constipation and other gastrointestinal symptoms
• TSH during concurrent levothyroxine
• Ciclosporin, tacrolimus or mycophenolate concentrations during combined use and after withdrawal
• Signs of peritonitis in people receiving peritoneal dialysis

Clinical pharmacology

A non-absorbed, calcium-free poly(allylamine hydrochloride) polymer that binds intestinal phosphate through ionic and hydrogen bonding. The hydrochloride counter-ion may increase chloride and contribute to lower bicarbonate.

Formulation and product differences

• The selected product is a film-coated sevelamer hydrochloride tablet that must be swallowed whole.
• Hydrochloride and carbonate products should not be assumed to have identical formulations, licensed populations or administration options.
• The selected formulation contains no calcium or metal.

Tablet

Route: Oral

Strengths: 800 mg