Renagel (sevelamer hydrochloride) is a non-calcium, non-aluminum phosphate binder specifically formulated for the management of hyperphosphatemia in patients undergoing dialysis for chronic kidney disease. This polymer-based medication works by binding dietary phosphate in the digestive tract, preventing its absorption and facilitating excretion. Clinically proven to effectively reduce serum phosphate levels, Renagel helps address a critical complication of end-stage renal disease while avoiding the risks associated with metal-based binders. Its unique mechanism offers nephrologists and patients a valuable tool in managing mineral and bone disorders associated with renal failure.

Features

• Contains sevelamer hydrochloride as active pharmaceutical ingredient
• Polymer-based phosphate binding technology
• Available in 400 mg and 800 mg tablets
• Non-absorbed therapeutic agent
• Does not contain calcium, aluminum, or magnesium
• Vegan-friendly formulation
• White, capsule-shaped tablets with debossed identification codes
• Stable at room temperature without special handling requirements

Benefits

• Effectively reduces serum phosphate levels in dialysis patients
• Minimizes risk of vascular calcification associated with hyperphosphatemia
• Avoids calcium loading that can contribute to cardiovascular complications
• Eliminates aluminum exposure concerns present with some alternative binders
• Helps maintain appropriate calcium-phosphorus product levels
• Supports overall bone mineral metabolism management in renal failure

Common use

Renagel is primarily prescribed for the control of serum phosphorus levels in patients with chronic kidney disease who are on hemodialysis. It is indicated specifically for the treatment of hyperphosphatemia, a common and serious complication of end-stage renal disease that contributes significantly to cardiovascular morbidity and mortality. The medication is typically used as part of a comprehensive management approach that includes dietary phosphate restriction and adequate dialysis. Clinical evidence supports its use in both adult and pediatric dialysis populations, though dosage adjustments are necessary based on individual patient requirements and serum phosphate levels.

Dosage and direction

The recommended starting dose for Renagel is 800-1600 mg administered orally with each meal, based on serum phosphorus level. Dosage should be individualized according to the patient’s serum phosphate levels and the desired phosphate range. Tablets should be swallowed whole with water and taken with meals—do not crush, chew, or break tablets before administration. The typical daily dose ranges from 2400 mg to 4800 mg divided among meals, though some patients may require up to 6400 mg daily. Serum phosphorus levels should be monitored regularly, and dosage titrated every 2-4 weeks as necessary to achieve target phosphate levels of 3.5-5.5 mg/dL. For patients switching from calcium-based binders, Renagel should be initiated at the same number of tablets per meal.

Precautions

Patients should be advised that Renagel may reduce the absorption of concurrently administered medications. Other drugs should be taken at least one hour before or three hours after Renagel administration. Close monitoring of serum calcium, bicarbonate, and chloride levels is recommended as mild metabolic acidosis may occur. Vitamin D and other fat-soluble vitamin levels should be monitored periodically during long-term therapy. Use with caution in patients with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders. Patients with diverticulitis or other severe gastrointestinal disorders may experience worsening of symptoms. Serum phosphorus levels should be monitored regularly to avoid hypophosphatemia. Not recommended for use in patients with hypophosphatemia or bowel obstruction.

Contraindications

Renagel is contraindicated in patients with hypophosphatemia or known bowel obstruction. The medication should not be used in patients with a history of allergic reaction to sevelamer hydrochloride or any component of the formulation. It is contraindicated in patients with fecal impaction and should be used with extreme caution in those with significant gastrointestinal disorders including severe constipation, ileus, or gastrointestinal surgery. Not indicated for use in non-dialysis patients or those with normal renal function. Should not be administered to patients with acute renal failure not yet on dialysis.

Possible side effect

The most commonly reported adverse reactions involve the gastrointestinal system, including nausea (16%), vomiting (14%), diarrhea (14%), dyspepsia (12%), abdominal pain (9%), and flatulence (8%). Constipation may occur in approximately 8% of patients. Less frequently reported effects include headache (5%), infection (4%), and pain (3%). Serious but rare adverse events include intestinal obstruction, ileus, and bowel perforation, particularly in patients with pre-existing gastrointestinal disorders. Allergic reactions including rash, pruritus, and urticaria have been reported in less than 1% of patients. Metabolic acidosis may develop with long-term use, requiring monitoring of acid-base status.

Drug interaction

Renagel has demonstrated interactions with several medications when administered concurrently. It significantly reduces the bioavailability of ciprofloxacin (approximately 50% reduction) and should be administered at least 2 hours before or 6 hours after quinolone antibiotics. Similar separation is recommended for tetracycline antibiotics. The absorption of levothyroxine is reduced by up to 30% when co-administered with Renagel—dosing should be separated by at least 4 hours. Interactions have been observed with warfarin, where a 10-20% reduction in INR may occur, requiring closer monitoring. The medication may decrease absorption of fat-soluble vitamins (A, D, E, K) and folic acid. Anticonvulsants such as phenytoin and valproic acid may have reduced absorption when taken with Renagel.

Missed dose

If a dose is missed, patients should take it with their next meal. However, if it is almost time for the next scheduled dose, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not double the dose to make up for a missed administration. Consistency with meal-time dosing is important for optimal phosphate binding efficacy. Healthcare providers should educate patients about the importance of adherence to the prescribed dosing schedule while providing clear guidance for handling missed doses. If multiple doses are missed, serum phosphorus levels should be monitored and the healthcare team notified for potential dosage adjustment.

Overdose

There is limited experience with Renagel overdose due to its minimal systemic absorption. The polymer is not absorbed from the gastrointestinal tract, so systemic toxicity is unlikely. In cases of accidental ingestion of large quantities, the primary risk would be related to gastrointestinal obstruction or severe constipation. Management should be symptomatic and supportive, with particular attention to bowel function. Severe constipation may require appropriate laxative therapy or enemas. In cases of suspected intestinal obstruction, radiographic evaluation and surgical consultation may be necessary. Hemodialysis is not expected to enhance elimination of sevelamer as it is not systemically absorbed. Patients should be monitored for signs of hypophosphatemia if massive overdose occurs.

Storage

Renagel tablets should be stored at controlled room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container with the lid tightly closed to protect from moisture. Do not store in bathroom cabinets or other humid locations. Keep out of reach of children and pets. Do not use if the packaging is damaged or if tablets show signs of deterioration. The medication should not be frozen. Properly discard any unused medication after the expiration date printed on the packaging. Do not transfer tablets to other containers as this may affect stability.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Renagel is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Treatment decisions should be made based on individual patient assessment by a licensed physician. The prescribing information provided here may not include all possible uses, directions, precautions, or interactions. Always consult the full prescribing information and discuss with your healthcare provider before starting or changing any medication regimen. Actual clinical effects may vary among individual patients. Serious side effects should be reported to a healthcare professional immediately.

Reviews

Clinical studies have demonstrated Renagel’s efficacy in maintaining serum phosphorus levels within target range in approximately 60-70% of dialysis patients. In a 52-week study involving over 200 hemodialysis patients, Renagel maintained mean serum phosphorus between 5.2-5.8 mg/dL throughout the treatment period. Nephrologists report satisfactory phosphate control with the advantage of avoiding calcium loading, particularly beneficial for patients with vascular calcification. Patient satisfaction surveys indicate generally good tolerability, though gastrointestinal side effects remain a consideration for some individuals. Long-term data suggests sustained efficacy without development of tolerance. Comparative studies show similar phosphate control to calcium-based binders with significantly less hypercalcemia. The medication receives particular praise for its safety profile in patients requiring long-term phosphate binding therapy.