Brand names: Renagel, Renvela
Drug class: Phosphate-reducing Agents

Medically reviewed by Drugs.com on Apr 10, 2024. Written by ASHP.

Introduction

Phosphate binder used to reduce the intestinal absorption of phosphates; allylamine polymer (cross-linked with epichlorohydrin).

Uses for Sevelamer (Local)

Hyperphosphatemia

Reduction of serum phosphorus in patients with chronic kidney disease (CKD) who are undergoing dialysis.

Risk of hypercalcemia is less than with calcium salts.

Safety and efficacy not established in patients with CKD who are not undergoing dialysis.

Sevelamer (Local) Dosage and Administration

Administration

Oral Administration

Administer orally 3 times daily with meals.

Dosage

Available as sevelamer carbonate and sevelamer hydrochloride; dosage expressed in terms of the salts. Sevelamer carbonate dosage expected to be similar to that of sevelamer hydrochloride because of rapid disintegration of sevelamer carbonate tablets in gastric hydrochloric acid.

Adults

Hyperphosphatemia in CKD Patients Undergoing Dialysis

Sevelamer Carbonate

Initial dosage in patients not currently receiving a phosphate binder (e.g., calcium acetate) depends on serum phosphorus concentrations.

Initial dosage in patients being transferred to sevelamer from calcium acetate therapy depends on current calcium acetate dosage.

For the treatment of hyperphosphatemia in patients currently receiving sevelamer hydrochloride therapy, the recommended initial dosage of sevelamer carbonate is equivalent to the patient's current sevelamer hydrochloride dosage on a gram per gram basis.

Adjust dosage of sevelamer carbonate for all patients according to the patient’s serum phosphorus concentrations with the goal of controlling serum phosphorus concentrations within the target range of 3.5–5.5 mg/dL. Increase or decrease dosage in increments of 1 tablet (800 mg) per meal at 2-week intervals as needed.

Average dosage of sevelamer carbonate in one study was 6 g daily; maximum dosage studied was 14 g daily.

Sevelamer Hydrochloride

Initial dosage in patients not currently receiving a phosphate binder (e.g., calcium acetate) depends on serum phosphorus concentrations.

Initial dosage in patients being transferred to sevelamer from calcium acetate therapy depends on current calcium acetate dosage.

Adjust dosage of sevelamer hydrochloride for all patients according to serum phosphorus concentrations with the goal of reducing concentrations to ≤5.5 mg/dL. Increase or decrease dosage in increments of 1 tablet (400 or 800 mg) per meal at 2-week intervals as needed.

Average dosage of sevelamer hydrochloride in one study was 2.4 g per meal (7.2 g daily); maximum average dosage studied was 13 g daily.

Special Populations

Geriatric Patients

Select dosage cautiously, usually initiating therapy at the low end of the dosage range.

Cautions for Sevelamer (Local)

Contraindications

• Hypophosphatemia.

• Bowel obstruction.

Warnings/Precautions

General Precautions

GI Disease or Surgery

Use with caution in patients with swallowing or severe GI motility disorders (including severe constipation), dysphagia, or major GI tract surgery. Provide appropriate treatment to patients who develop constipation or experience worsening of existing constipation to avoid the development of severe complications (e.g., fecal impaction, ileus, intestinal obstruction, intestinal perforation).

Monitor patients on peritoneal dialysis for proper use of aseptic technique and for signs and symptoms of peritonitis.

Effects on Vitamins

Sevelamer hydrochloride has decreased plasma concentrations of vitamins D, E, and K and folic acid in animals when given at doses 6–10 times the recommended human dosage. No evidence of decreased vitamin concentrations in some short-term studies of patients receiving sevelamer hydrochloride; however, a decrease in serum 25-hydroxy vitamin D₃ concentrations from 39 to 34 mcg/mL (normal range: 10–55 mcg/mL) was reported in one 1-year study. Most patients (75%) in clinical studies of sevelamer hydrochloride have received vitamin supplements. Monitor for reduced serum concentrations of vitamin D, E, K (clotting factors) and folic acid.

Adequate Patient Monitoring

Monitor serum chloride and bicarbonate concentrations.

Specific Populations

Pregnancy

Category C.

Requirements for vitamins and other nutrients are increased during pregnancy; the effect of sevelamer on vitamin and other nutrient absorption has not been studied in pregnant women.

Lactation

Caution is advised if used in nursing women.

Pediatric Use

Safety and efficacy not established in children <18 years of age.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution. (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, nausea, peritonitis (in patients on peritoneal dialysis), vomiting.

Drug Interactions

Effects on GI Absorption of Drugs

Possible decreased bioavailability of orally administered drugs given concomitantly; when reduced bioavailability would have a clinically important effect on the drug's safety or efficacy, administer the drug ≥1 hour before or 3 hours after sevelamer administration or consider monitoring blood concentrations.

Specific Drugs

No drug interaction studies have been performed with sevelamer carbonate. Drug interactions studies have been performed with sevelamer hydrochloride in humans.

Sevelamer (Local) Pharmacokinetics

Absorption

Not systemically absorbed following oral administration in healthy individuals; no absorption studies to date in patients with renal disease.

Elimination

Elimination Route

Excreted in the feces as unabsorbed drug bound to phosphate ions and to bile acids.

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C). Protect from moisture.

Actions

• Following oral administration, binds phosphate ions through ionic and hydrogen bonding.

• Reduced phosphate absorption decreases serum and urinary phosphorus concentrations and increases fecal excretion of phosphorus.

• No substantial changes in serum calcium concentrations reported.

• Binds bile acids in the intestine, forming a nonabsorbable complex.

• May interfere with normal fat absorption, possibly reducing absorption of fat-soluble vitamins (e.g., vitamin A, D, K).

• Decreases serum total and LDL-cholesterol concentrations; does not appear to alter serum HDL-cholesterol or triglyceride concentrations.

• Does not alter serum chloride, bicarbonate, or albumin concentrations.

• Does not contain aluminum or other metals; does not produce aluminum toxicity.

Advice to Patients

• Importance of adherence to instructions about diet.

• Importance of taking sevelamer with meals.

• Importance of advising patients to take certain other drugs (e.g., antiarrhythmic agents, anticonvulsants, ciprofloxacin) ≥1 hour before or 3 hours after taking sevelamer.

• Importance of advising patients of risk of severe complications from untreated constipation; importance of patients promptly reporting new onset or worsening of existing constipation to clinician.

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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