Renagel (sevelamer hydrochloride) is a non-calcium, non-aluminum phosphate binder specifically formulated for the management of hyperphosphatemia in patients undergoing hemodialysis. This polymer-based therapeutic agent offers a targeted approach to reducing serum phosphate levels without contributing to systemic metal accumulation. Its unique mechanism selectively binds dietary phosphate in the gastrointestinal tract, preventing absorption and facilitating excretion. Clinical evidence supports its role in maintaining mineral balance and potentially slowing vascular calcification progression in end-stage renal disease patients.

Features

• Contains sevelamer hydrochloride as active pharmaceutical ingredient
• Polymer-based phosphate binding technology
• Non-absorbed therapeutic compound
• Available in 400 mg and 800 mg tablets
• White, oval-shaped film-coated tablets
• Does not contain calcium or aluminum
• pH-dependent binding mechanism
• Binds approximately 2.4 mEq of phosphate per gram

Benefits

• Effectively reduces serum phosphate levels in dialysis patients
• Minimizes risk of hypercalcemia associated with calcium-based binders
• Reduces progression of vascular calcification
• Lowers calcium-phosphate product
• May decrease parathyroid hormone levels
• No systemic absorption or metabolic alterations

Common use

Renagel is primarily prescribed for the control of serum phosphorus in patients with chronic kidney disease on hemodialysis. It is typically administered as part of a comprehensive renal management protocol that includes dietary phosphate restriction and adequate dialysis. The medication is used long-term to maintain phosphorus levels within the target range of 3.5-5.5 mg/dL, helping prevent complications associated with mineral and bone disorder in renal disease.

Dosage and direction

The recommended starting dose for Renagel is 800-1600 mg taken orally three times daily with meals. Dosage should be individualized based on serum phosphorus levels with regular monitoring. Tablets should be swallowed whole with water and taken with meals to maximize phosphate binding efficiency. Dose titration should occur in increments of 800 mg per day at two-week intervals based on serum phosphorus concentrations and tolerability. Most patients require 2400-4800 mg daily divided into three doses.

Precautions

Patients should be monitored for changes in serum calcium, bicarbonate, and chloride levels. Those with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders should use with caution. Regular assessment of nutritional status is recommended as phosphate binders may bind to vitamins and other medications. Patients with inflammatory bowel disease or bowel obstruction should be carefully evaluated before initiation. Serum phosphorus levels should be monitored weekly during dose titration and monthly during maintenance therapy.

Contraindications

Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction. It should not be used in patients with known hypersensitivity to sevelamer hydrochloride or any component of the formulation. The medication is not indicated for use in patients not on dialysis and is contraindicated in those with fecal impaction. Use in children under 18 years has not been established and is not recommended.

Possible side effect

Common adverse reactions include nausea (16%), vomiting (14%), diarrhea (14%), dyspepsia (12%), and abdominal pain (9%). Less frequently reported effects include flatulence (8%), constipation (7%), and headache (5%). Serious but rare side effects may include intestinal obstruction, fecal impaction, and bowel perforation. Some patients may experience acid-base changes including decreased bicarbonate levels and metabolic acidosis. Allergic reactions including rash and pruritus have been reported in less than 3% of patients.

Drug interaction

Renagel may decrease the absorption of concurrently administered oral medications. Specifically, it may reduce bioavailability of ciprofloxacin (50%), mycophenolate mofetil (30%), and levothyroxine (25%). Administration of other drugs should be spaced at least one hour before or three hours after Renagel dosing. The medication may bind to fat-soluble vitamins (A, D, E, K) and folic acid, requiring supplementation monitoring. No interactions with warfarin, digoxin, or enalapril have been observed in clinical studies.

Missed dose

If a dose is missed, patients should take it with their next meal if remembered within a reasonable time. However, if it is nearly time for the next scheduled dose, the missed dose should be skipped. Patients should not double the dose to make up for a missed administration. Consistent dosing with meals is important for optimal phosphate control, so patients should be educated about maintaining regular dosing schedules.

Overdose

No cases of overdose have been reported in clinical studies. Given that Renagel is not absorbed systemically, the primary risk of excessive dosing would relate to gastrointestinal effects such as severe constipation or bowel obstruction. Management should be symptomatic and supportive. In cases of suspected overdose, medical attention should be sought, particularly if symptoms of bowel obstruction occur. Hemodialysis is not effective for removal of the drug as it is not systemically absorbed.

Storage

Store at room temperature between 15-30°C (59-86°F) in the original container. Keep tightly closed and protect from moisture. Do not remove desiccant from the bottle. Keep out of reach of children. Do not use if the seal is broken or missing. Tablets should be protected from excessive heat and humidity. Do not transfer to other containers as moisture protection may be compromised.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions should be made by qualified healthcare professionals based on individual patient circumstances. Patients should not alter their medication regimen without consulting their physician. The prescribing information provided here may not include all possible uses, directions, precautions, or interactions.

Reviews

Clinical studies demonstrate Renagel’s efficacy in maintaining serum phosphorus levels below 6.0 mg/dL in 60% of hemodialysis patients. Long-term studies show significant reduction in coronary and aortic calcification progression compared to calcium-based binders. Patient satisfaction surveys indicate good tolerability with 75% of patients reporting adequate gastrointestinal tolerance after the initial adjustment period. Nephrologists report consistent phosphate control with 80% achieving target levels with appropriate dose titration.