Sevelamer Hydrochloride

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

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.

Patients not taking a Phosphate Binder: The recommended starting dose of Sevelamer is 800 to 1600 mg, which can be administered as two to four 400 mg Sevelamer tablets, with meals based on serum phosphorus level. Renophos 400 Recommendation for the patients with hyperphosphatemia is given below-

Starting dose of Renophos for dialysis patients not taking any phosphate binder:

• Serum Phosphorus >5.5 and <7.5 mg/dL: 800 mg (2 tablets) three times daily with meals
• Serum Phosphorus ≥7.5 and <9.0 mg/dL: 1200 mg (3 tablets) three times daily with meals
• Serum Phosphorus ≥9.0 mg/dL: 1600 mg (4 tablets) three times daily with meals

Starting dose for dialysis patients switching from calcium acetate to Sevelamer:

• Calcium Acetate 667 mg (1 tablet): Sevelamer 800 mg (2 tablets)
• Calcium Acetate 1334 mg (2 tablets): Sevelamer 1200 mg (3 tablets)
• Calcium Acetate 2001 mg (3 tablets): Sevelamer 2000 mg (5 tablets)

Dose titration guideline:

• Serum Phosphorus >5.5 mg/dL: Increase 400 mg (1 tablet) per meal at 2 week intervals
• Serum Phosphorus 3.5-5.5 mg/dL: Maintain current dose
• Serum Phosphorus <3.5 mg/dL: Decrease 400 mg (1 tablet) per meal

Dose titration for all patients taking Sevelamer: Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dl or less. The dose may be increased or decreased by one tablet per meal at two week intervals as necessary.

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

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

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.

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

Drugs for reduction of serum phosphorus in patients with ESRD