Renagel (sevelamer hydrochloride) is a non-calcium, non-aluminum phosphate binder specifically formulated for the management of hyperphosphatemia in patients undergoing dialysis due to chronic kidney disease. By effectively reducing serum phosphate levels, Renagel plays a critical role in mitigating the risk of vascular calcification and secondary hyperparathyroidism, common complications associated with end-stage renal disease. Its unique polymer-based mechanism offers a targeted approach to phosphate management without adding systemic calcium or metal load, making it a preferred choice among nephrologists for long-term patient care. This product is available only by prescription and should be used under strict medical supervision as part of a comprehensive renal care plan.

Features

• Contains sevelamer hydrochloride as the active pharmaceutical ingredient
• Available in 400 mg and 800 mg tablets for flexible dosing
• Non-absorbed polymer that binds dietary phosphate in the gastrointestinal tract
• Free from calcium, aluminum, and other metal compounds
• Does not contribute to metabolic alkalosis
• Suitable for use in both hemodialysis and peritoneal dialysis patients

Benefits

• Effectively lowers serum phosphate levels toward target ranges in CKD patients on dialysis
• Reduces the risk of cardiovascular calcification and associated morbidity
• Helps maintain bone mineral metabolism by controlling phosphate-induced parathyroid hormone elevation
• Avoids calcium accumulation, decreasing potential for hypercalcemia and adynamic bone disease
• Provides a metal-free alternative to traditional phosphate binders, minimizing long-term toxicity concerns
• Supports overall management of mineral and bone disorder in chronic kidney disease

Common use

Renagel is primarily indicated for the control of serum phosphorus in patients with chronic kidney disease on hemodialysis or peritoneal dialysis. It is used as part of a treatment regimen that includes dietary phosphate restriction and, when appropriate, adjustment of dialysis parameters. Clinical use focuses on maintaining serum phosphorus within the recommended range of 3.5 to 5.5 mg/dL, as elevated levels are associated with increased cardiovascular risk and mortality in this patient population.

Dosage and direction

The recommended starting dose for Renagel is 800-1600 mg taken orally with meals three times daily, depending on serum phosphorus levels. Tablets should be swallowed whole with water and taken with meals to maximize phosphate binding efficacy. Dosage should be titrated based on serum phosphorus concentrations, with increments or decrements of one tablet per meal every 2-4 weeks as needed. The maximum daily dose should not exceed 13 grams (16 tablets of 800 mg strength). For patients switching from calcium-based binders, the equivalent Renagel dose is approximately calculated on a milligram-to-milligram basis of elemental calcium content.

Precautions

Patients should be monitored regularly for serum calcium, bicarbonate, and chloride levels, as Renagel may cause metabolic acidosis. Those with dysphagia, swallowing disorders, or severe gastrointestinal motility issues should use with caution due to potential for tablet obstruction. Vitamin D and other fat-soluble vitamin levels should be monitored periodically, as Renagel may decrease their absorption. Patients with inflammatory bowel disease or bowel obstruction should be carefully evaluated before initiation. Dental status should be assessed regularly as tablet ingestion may affect dentures or dental work.

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 product is not indicated for use in patients not on dialysis, as safety and efficacy have not been established in this population. Use is contraindicated in patients with fecal impaction or those at high risk for developing bowel obstruction.

Possible side effects

The most common adverse reactions involve the gastrointestinal system, including nausea (16%), vomiting (14%), diarrhea (12%), dyspepsia (10%), and abdominal pain (9%). Constipation may occur in approximately 8% of patients. Less frequently, flatulence, bloating, and acid regurgitation have been reported. Serious but rare side effects include intestinal obstruction, perforation, and fecal impaction, particularly in patients with pre-existing bowel disorders. Isolated cases of rash and pruritus have been reported, though true allergic reactions are uncommon.

Drug interaction

Renagel may decrease the bioavailability of concurrently administered oral medications. Specifically, it has been shown to reduce absorption of ciprofloxacin (approximately 50%), mycophenolate mofetil (30%), and levothyroxine (25%). Other medications known to interact include oral iron supplements, digoxin, warfarin, and certain anticonvulsants. To minimize interactions, other medications should be taken at least one hour before or three hours after Renagel administration. Close monitoring of drug levels and clinical response is recommended when co-administering with narrow therapeutic index drugs.

Missed dose

If a dose is missed, the patient should take it with the 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 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.

Overdose

There is limited experience with Renagel overdose. Given its mechanism as a non-absorbed polymer, systemic toxicity is unlikely. However, large overdoses may lead to severe gastrointestinal complaints including obstruction, particularly in patients with pre-existing bowel issues. Treatment should be symptomatic and supportive. In cases of suspected intestinal obstruction, appropriate radiographic evaluation and surgical consultation should be obtained. Hemodialysis is not effective for removal of the drug as it is not systemically absorbed.

Storage

Renagel tablets should be stored at room temperature between 15-30°C (59-86°F) in their original container with the lid tightly closed. Protect from moisture and excessive heat. Keep out of reach of children and pets. Do not use tablets that show signs of discoloration, cracking, or other physical deterioration. The product should not be used beyond the expiration date printed on the packaging.

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 provider. Dosage and administration should be determined by a physician familiar with the patient’s medical history and current condition. Patients should not adjust their dosage without consulting their healthcare provider. The manufacturer is not responsible for any consequences resulting from the use or misuse of this information.

Reviews

Clinical studies demonstrate Renagel’s efficacy in maintaining serum phosphorus levels within target range in 60-70% of dialysis patients. Nephrologists report satisfactory phosphate control with reduced calcium load compared to calcium-based binders. Some patients note gastrointestinal tolerability issues, particularly during the initial treatment phase, though these often subside with continued use. Long-term users appreciate the metal-free composition and the ability to avoid calcium accumulation. Healthcare providers value the flexible dosing options and the established safety profile in chronic kidney disease management.