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

Sevelamer Hydrochloride is used for the management of serum phosphorus in patients with chronic kidney disease (CKD) undergoing dialysis. Elevated phosphate levels or uncontrolled hyperphosphataemia may lead to secondary hyperparathyroidism, renal bone disease, vascular and soft tissue calcification, and cardiovascular complications. It is a non-absorbed, calcium-free and aluminium-free polymer-based phosphate binder. Since it is not systemically absorbed, it does not cause calcium or aluminium toxicity. When taken with meals, it binds dietary phosphate in the intestine and reduces its absorption.

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 evaluated in human drug–drug interaction studies with ciprofloxacin, digoxin, warfarin, enalapril, metoprolol, and iron preparations.

Sevelamer is contraindicated in patients with hypophosphatemia, bowel obstruction, or known hypersensitivity to sevelamer hydrochloride or any of its components.

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

Pregnancy Category C. Adequate and well-controlled studies in pregnant or nursing women are not available. Sevelamer should be used during pregnancy or breastfeeding only if the potential benefit justifies the potential risk.

The safety and efficacy of Sevelamer have not been established in patients with swallowing difficulties, severe gastrointestinal motility disorders (including severe constipation), or those who have undergone major gastrointestinal surgery. Caution is advised in such patients.

No cases of Sevelamer overdose have been reported in patients. Since it is not systemically absorbed, the risk of systemic toxicity is considered very low.

Drugs used for lowering serum phosphorus in patients with end-stage renal disease (ESRD)