Renagel (sevelamer hydrochloride) is a non-calcium, non-alcium phosphate binder specifically formulated for the reduction of serum phosphorus in patients with chronic kidney disease on dialysis. This polymer-based medication offers a targeted approach to managing hyperphosphatemia, a serious complication of end-stage renal disease associated with increased cardiovascular risk and mortality. By binding dietary phosphate in the digestive tract, Renagel prevents its absorption into the bloodstream, helping maintain phosphorus levels within recommended ranges. Its unique formulation makes it particularly valuable for patients who cannot tolerate or have contraindications to calcium-based binders.

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 or aluminum
• Specifically designed for dialysis patients
• White to off-white tablet formulation
• Biconvex tablet shape with engraved identification codes

Benefits

• Effectively reduces serum phosphate levels in dialysis patients
• Helps maintain phosphorus within KDOQI recommended ranges (3.5-5.5 mg/dL)
• Reduces risk of cardiovascular complications associated with hyperphosphatemia
• Minimizes calcium loading compared to calcium-based binders
• May help slow progression of vascular calcification
• Does not contribute to aluminum accumulation or toxicity

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 for patients with end-stage renal disease who require phosphate binding therapy to manage hyperphosphatemia. The medication is typically used as part of a comprehensive renal management program that includes dietary phosphate restriction and adequate dialysis. Clinical studies have demonstrated its efficacy in maintaining phosphorus levels within target ranges while avoiding the calcium loading associated with traditional phosphate binders.

Dosage and direction

The recommended starting dose for Renagel is 800-1600 mg taken orally with meals three times daily. The exact dosage should be individualized based on serum phosphorus levels and should be titrated by 800 mg per meal at two-week intervals as necessary. Tablets should be swallowed whole with water and taken with meals to maximize phosphate binding efficiency. The total daily dose typically ranges from 2400 mg to 4800 mg, though some patients may require up to 6400 mg daily. Serum phosphorus levels should be monitored regularly, and dosage adjustments made accordingly under medical supervision.

Precautions

Patients should be monitored for changes in serum calcium, bicarbonate, and chloride levels during treatment. Those with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders should use Renagel with caution due to the potential for esophageal tablet retention. Vitamin D deficiency may develop during treatment, requiring appropriate supplementation. Patients should maintain adequate hydration while taking Renagel. Regular monitoring of lipid profiles is recommended as the medication may affect cholesterol levels. Pregnant women should use Renagel only if clearly needed, as adequate human reproduction studies are lacking.

Contraindications

Renagel is contraindicated in patients with bowel obstruction, hypophosphatemia, or known hypersensitivity to sevelamer hydrochloride or any component of the formulation. The medication should not be used in patients with fecal impaction or those at high risk for bowel obstruction. It is not indicated for use in patients not on dialysis or in pediatric patients under 18 years of age. Patients with acute kidney injury or those with functional gastrointestinal disorders that might predispose to obstruction should avoid Renagel therapy.

Possible side effects

The most common adverse reactions involve the gastrointestinal system, including nausea (8%), vomiting (9%), diarrhea (13%), dyspepsia (10%), and abdominal pain (6%). Constipation occurs in approximately 8% of patients. Less frequently reported side effects include flatulence, acid regurgitation, and intestinal obstruction. Some patients may experience headache, infection, or pain. Serious but rare adverse effects include intestinal perforation, bowel obstruction, and fecal impaction. Allergic reactions, though uncommon, may include rash, pruritus, and urticaria.

Drug interaction

Renagel may decrease the bioavailability of concurrently administered medications, particularly those with narrow therapeutic indices. Specifically, it may reduce absorption of ciprofloxacin (approximately 50% reduction), mycophenolate mofetil (30% reduction), and tacrolimus. Patients should take other medications at least one hour before or three hours after Renagel administration. The binding interaction may affect absorption of fat-soluble vitamins, necessitating monitoring and possible supplementation. Renagel does not interact with warfarin, digoxin, or enalapril to a clinically significant degree.

Missed dose

If a dose is missed, patients should take it as soon as they remember with their next meal. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. Patients should never double the dose to make up for a missed administration. Consistent dosing with meals is important for optimal phosphate control. Healthcare providers should educate patients about the importance of adherence to the prescribed dosing schedule and develop strategies to minimize missed doses.

Overdose

There is limited experience with Renagel overdose. Given its local action in the gastrointestinal tract and minimal systemic absorption, serious consequences of overdose are unlikely. However, massive overdose might lead to severe gastrointestinal complaints including obstruction. Treatment should be symptomatic and supportive. In cases of suspected overdose, medical attention should be sought promptly. Hemodialysis is not expected to enhance elimination of sevelamer due to its minimal systemic absorption.

Storage

Renagel tablets should be stored at room temperature between 15°C and 30°C (59°F and 86°F) in their original container. The medication should be protected from moisture and excessive heat. Keep the bottle tightly closed and away from direct sunlight. Do not store in bathroom cabinets where humidity levels may fluctuate. Keep out of reach of children and pets. Do not use tablets that show signs of discoloration, cracking, or other physical deterioration.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Renagel should be used only under the supervision of a qualified healthcare provider. Treatment decisions should be based on individual patient characteristics and professional medical judgment. The prescribing physician should be consulted for complete information regarding indications, dosage, warnings, and precautions. Patients should not alter their treatment regimen without medical consultation.

Reviews

Clinical studies demonstrate that Renagel effectively reduces serum phosphorus levels in dialysis patients, with 60-70% of patients achieving target phosphorus levels in controlled trials. Nephrologists report satisfactory phosphate control with reduced calcium loading compared to traditional binders. Patients generally tolerate the medication well, though gastrointestinal side effects remain a consideration. Long-term studies suggest potential benefits in reducing cardiovascular calcification progression. The non-absorbable nature of the drug is particularly valued in patients requiring long-term phosphate management.