Renagel: Advanced Phosphate Control for Chronic Kidney Disease

Renagel

Renagel

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Product dosage: 800mg
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Synonyms

Renagel (sevelamer hydrochloride) is a non-calcium, non-metal phosphate binder specifically formulated for the management of hyperphosphatemia in adult patients undergoing dialysis. It represents a critical therapeutic option within nephrology, designed to reduce serum phosphorus levels without contributing to calcium accumulation or systemic metal exposure. By selectively binding dietary phosphate in the gastrointestinal tract, Renagel helps mitigate a key risk factor associated with mineral and bone disorder in chronic kidney disease. Its targeted mechanism supports long-term treatment strategies aimed at improving patient outcomes and reducing cardiovascular complications linked to elevated phosphorus.

Features

  • Active ingredient: Sevelamer hydrochloride
  • Pharmaceutical form: Film-coated tablets (400 mg and 800 mg)
  • Mechanism: Non-absorbed polymeric phosphate binder
  • Excipients: Includes colloidal silicon dioxide and stearic acid; gluten-free formulation
  • No calcium, aluminum, or magnesium content
  • Prescription-only medication

Benefits

  • Effectively lowers and maintains serum phosphate within target range (3.5–5.5 mg/dL)
  • Reduces risk of vascular calcification and cardiovascular morbidity
  • Avoids calcium overload, decreasing potential for hypercalcemia and adynamic bone disease
  • Minimizes accumulation of toxic metals such as aluminum
  • Supports compliance through flexible dosing aligned with meals
  • Contributes to improved long-term bone and metabolic health in CKD patients

Common use

Renagel is indicated for the control of hyperphosphatemia in adult patients with chronic kidney disease on hemodialysis. It is used as part of a comprehensive treatment plan that includes dietary phosphate restriction and dialysis. Treatment is typically initiated when serum phosphorus levels exceed 5.5 mg/dL and is adjusted based on regular biochemical monitoring. Renagel may be used both in incident and prevalent dialysis patients and is often selected for individuals with or at risk for hypercalcemia.

Dosage and direction

The recommended starting dose for Renagel is 800–1600 mg taken orally with meals three times daily. Dosage should be individualized based on serum phosphorus levels and tolerated up to 13 grams per day. Tablets should be swallowed whole with water and must be taken with meals to maximize phosphate binding efficacy. Serum phosphorus and calcium should be monitored every 2–3 weeks during dose titration and periodically thereafter. Dose adjustments should be made in increments of 400–800 mg per meal under clinical supervision.

Precautions

  • Use with caution in patients with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders
  • May cause or worsen constipation; adequate hydration and dietary fiber intake are advised
  • Not recommended in patients with bowel obstruction or major gastrointestinal surgery
  • Vitamin D and other fat-soluble vitamin levels should be monitored during long-term therapy
  • Serum chloride levels may increase due to drug’s exchange of chloride for phosphate
  • Use during pregnancy only if clearly needed; not studied in pregnant women

Contraindications

  • Hypersensitivity to sevelamer hydrochloride or any component of the formulation
  • Bowel obstruction
  • Hypophosphatemia
  • Fecal impaction

Possible side effects

Common adverse reactions (≥5%) include:

  • Nausea
  • Vomiting
  • Diarrhea
  • Dyspepsia
  • Abdominal pain
  • Constipation

Less frequent side effects may include:

  • Flatulence
  • Intestinal obstruction or perforation (rare)
  • Pruritus
  • Headache
  • Hypertension or hypotension

Drug interaction

  • Renagel may decrease the absorption of concomitantly administered oral medications, including:
    • Anticonvulsants (e.g., phenytoin)
    • Antiarrhythmics (e.g., quinidine)
    • Antibiotics (e.g., ciprofloxacin)
    • Thyroxine
    • Fat-soluble vitamins (A, D, E, K)
  • Administer other oral medications at least 1 hour before or 3 hours after Renagel
  • May alter the efficacy of drugs with narrow therapeutic indices; close monitoring is required

Missed dose

If a dose is missed, it should be taken with the next meal. Do not double the dose to make up for a missed administration. Consistent intake with meals is important to maintain effective phosphate binding.

Overdose

There is no specific antidote for Renagel overdose. Since the drug is not systemically absorbed, manifestations would primarily relate to gastrointestinal effects such as severe constipation or obstruction. Treatment should be symptomatic and supportive. In cases of suspected obstruction, appropriate diagnostic and therapeutic measures should be undertaken.

Storage

Store at room temperature (15–30°C or 59–86°F). Keep in the original container, tightly closed, and protect from moisture. Keep out of reach of children. Do not use beyond the expiration date printed on the packaging.

Disclaimer

This information is intended for healthcare professionals and should not replace clinical judgment. Prescribers should refer to the full prescribing information and consider individual patient factors. Patients must adhere to their nephrologist’s recommendations and report any adverse effects promptly.

Reviews

Renagel has been evaluated in multiple clinical trials demonstrating significant phosphate-lowering efficacy. In a 52-week study, 75% of patients achieved serum phosphorus levels below 6.5 mg/dL. Nephrologists frequently report satisfactory control of hyperphosphatemia with a favorable tolerability profile compared to calcium-based binders. Some patients note gastrointestinal discomfort, which often resolves with dose adjustment or dietary management. Long-term data support its role in reducing cardiovascular calcification progression.