Renagel

Renagel is used for reducing the amount of phosphorus in the blood in patients with chronic kidney disease who are on dialysis.

Product dosage: 800mg
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Synonyms Phosblock Renegal Renvela Sevelamero Sevelamerum

Renagel (sevelamer hydrochloride) is a non-calcium, non-aluminum phosphate binder specifically formulated for the management of hyperphosphatemia in patients undergoing hemodialysis. As a key therapeutic agent in nephrology, it effectively reduces serum phosphate levels by binding dietary phosphate in the gastrointestinal tract, preventing its absorption. Its unique polymer-based mechanism offers a critical advantage for patients requiring long-term dialysis, supporting both metabolic balance and bone health. Renagel represents a cornerstone in renal care, aligning with clinical guidelines to mitigate cardiovascular risks associated with elevated phosphorus.

Features

• Contains sevelamer hydrochloride as the active pharmaceutical ingredient
• Available in 400 mg and 800 mg film-coated tablets
• Non-absorbed polymeric hydrogel
• Does not contain calcium, aluminum, or other metals
• Requires no hepatic metabolism; eliminated intact via the fecal route
• pH-dependent phosphate binding within the gastrointestinal tract

Benefits

• Effectively lowers and maintains serum phosphorus within target range (3.5–5.5 mg/dL)
• Reduces the risk of vascular calcification and associated cardiovascular events
• Minimizes bone resorption and supports skeletal health in renal impairment
• Avoids calcium overload, decreasing potential for hypercalcemia
• Suitable for long-term use with a well-characterized safety profile
• Compatible with other common renal medications and dietary regimens

Common use

Renagel is indicated for the control of hyperphosphatemia in adult patients with chronic kidney disease on hemodialysis. It is prescribed as part of a comprehensive treatment plan that includes dietary phosphate restriction and dialysis. Clinical use focuses on patients who have serum phosphate levels exceeding 5.5 mg/dL, particularly those with or at risk for vascular calcification, or who cannot tolerate calcium-based binders.

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. Dosage should be individualized based on phosphate levels and tolerability, with regular monitoring every 2–4 weeks during dose titration. Tablets must be swallowed whole with water and should not be crushed or chewed. Take with meals to maximize binding of dietary phosphate.

Precautions

• Monitor serum calcium, bicarbonate, and chloride levels periodically due to potential for metabolic acidosis.
• Use with caution in patients with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders.
• Not recommended for patients with bowel obstruction or major gastrointestinal surgery history.
• Vitamin D and other fat-soluble vitamin levels should be monitored; supplementation may be necessary.
• Pregnancy Category C: use only if potential benefit justifies potential risk to the fetus.

Contraindications

• Hypersensitivity to sevelamer hydrochloride or any component of the formulation.
• Bowel obstruction or known structural disorders of the gastrointestinal tract.
• Hypophosphatemia.
• Patients with fecal impaction or acute gastrointestinal bleeding.

Possible side effect

Common side effects may include:

• Nausea, vomiting, diarrhea, or dyspepsia
• Abdominal pain or flatulence
• Constipation (may require laxative or dietary adjustment)
• Headache or dizziness

Less frequently, severe side effects can include:

• Intestinal obstruction or perforation (rare)
• Metabolic acidosis
• Drug rash or pruritus

Drug interaction

• Renagel may decrease the absorption of concomitantly administered oral medications, such as:
  • Levothyroxine
  • Quinolone antibiotics (e.g., ciprofloxacin)
  • Antifungals (e.g., ketoconazole)
  • Certain cardiovascular drugs (e.g., metoprolol, verapamil)
• Administer other oral medications at least 1 hour before or 3 hours after Renagel.
• No known interactions with drugs that are not administered orally.

Missed dose

If a dose is missed, take it as soon as remembered with food. If it is nearly time for the next dose, skip the missed dose and resume the regular schedule. Do not double the dose to make up for a missed one.

Overdose

There have been no reported cases of overdose with Renagel. Given its non-absorbable nature, symptoms would likely relate to gastrointestinal obstruction or severe constipation. Management is supportive; discontinue the drug and treat symptomatically. Dialysis is not effective for removal.

Storage

Store at room temperature (20–25°C or 68–77°F) in a dry place. Keep in the original container, tightly closed, and protect from moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging.

Disclaimer

This information is intended for healthcare professionals and educated patients under medical supervision. It is not exhaustive; always consult the full prescribing information and a qualified healthcare provider for personalized medical advice. Dosage, administration, and monitoring should be guided by a nephrologist or trained medical professional.

Reviews

Renagel is widely regarded in nephrology for its efficacy and safety profile. Clinical studies, such as the Dialysis Clinical Outcomes Revisited (DCOR) trial, have demonstrated its utility in reducing phosphorus without increasing calcium load. Many clinicians appreciate its role in minimizing cardiovascular calcification risk. Patient feedback often highlights gastrointestinal tolerability as a consideration, though many find it manageable with dose adjustment. Overall, it remains a trusted option within renal care protocols.