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Sevelamer

Class: Phosphate-removing Agents
VA Class: GU900
Chemical Name: 2-Propen-1-amine polymer with (chloromethyl)oxirane, carbonate
Molecular Formula: (C3H7N)m (C3H5ClO)n•H2CO3(C3H7N)m (C3H5ClO)n•HCl
CAS Number: 845273-93-0
Brands: Renagel, Renvela

Medically reviewed by Drugs.com on Dec 22, 2021. Written by ASHP.

Introduction

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

Uses for Sevelamer

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 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 Sevelamer Carbonate Dosage in Patients not Currently Receiving a Phosphate Binder

Serum Phosphorus Concentration (mg/dL)

Initial Sevelamer Carbonate Dosage

Number of Tablets per Dose

>5.5 and <7.5

800 mg 3 times daily

One 800-mg tablet

≥7.5 and <9

1.6 g 3 times daily

Two 800-mg tablets

≥9

1.6 g 3 times daily

Two 800-mg tablets

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

Initial Sevelamer Carbonate Dosage in Patients Being Transferred from Calcium Acetate Therapy

Calcium Acetate Dosage

Initial Sevelamer Carbonate Dosage

Number of Tablets per Dose

667 mg 3 times daily

800 mg 3 times daily

One 800-mg tablet

1.334 g 3 times daily

1.6 g 3 times daily

Two 800-mg tablets

2.001 g 3 times daily

2.4 g 3 times daily

Three 800-mg tablets

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 Sevelamer Hydrochloride Dosage in Patients not Currently Receiving a Phosphate Binder

Serum Phosphorus Concentration (mg/dL)

Initial Sevelamer Hydrochloride Dosage

Number of Tablets per Dose

>5.5 and <7.5

800 mg 3 times daily

Two 400-mg tablets or one 800-mg tablet

≥7.5 and <9

1.2 or 1.6 g 3 times daily

1.2-g dose: three 400-mg tablets

1.6-g dose: two 800-mg tablets

≥9

1.6 g 3 times daily

Four 400-mg tablets or two 800-mg tablets

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

Initial Sevelamer Hydrochloride Dosage in Patients Being Transferred from Calcium Acetate Therapy

Calcium Acetate Dosage

Initial Sevelamer Hydrochloride Dosage

Number of Tablets per Dose

667 mg 3 times daily

800 mg 3 times daily

Two 400-mg tablets or one 800-mg tablet

1.334 g 3 times daily

1.2 or 1.6 g 3 times daily

1.2-g dose: three 400-mg tablets

1.6-g dose: two 800-mg tablets

2.001 g 3 times daily

2 or 2.4 g 3 times daily

2-g dose: five 400-mg tablets

2.4-g dose: three 800-mg tablets

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.

Dosage Titration of Sevelamer Hydrochloride for All CKD Patients Undergoing Dialysis

Serum Phosphorus Concentration (mg/dL)

Dosage Adjustment

<3.5

Decrease dosage by 1 tablet (400 or 800 mg) per meal

3.5–5.5

Maintain current dosage

> 5.5

Increase dosage by 1 tablet (400 or 800 mg) per meal

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

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.

Interactions for Sevelamer

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.

Drug

Interaction

Comments

Antiarrhythmic agents

Possible decreased antiarrhythmic bioavailability with concomitant oral administration

Use concomitantly with caution; administer antiarrhythmics orally ≥1 hour before or 3 hours after sevelamer, or consider monitoring antiarrhythmic concentrations

Anticonvulsants

Possible decreased anticonvulsant bioavailability with concomitant oral administration

Use concomitantly with caution; administer anticonvulsants orally ≥1 hour before or 3 hours after sevelamer, or consider monitoring anticonvulsant concentrations

Ciprofloxacin

50% decrease in ciprofloxacin bioavailability reported with concomitant oral administration

Use concomitantly with caution; administer ciprofloxacin orally ≥1 hour before or 3 hours after sevelamer

Digoxin

Pharmacokinetic interaction unlikely

Enalapril

Pharmacokinetic interaction unlikely

Iron preparations (ferrous sulfate)

Pharmacokinetic interaction unlikely

Levothyroxine

Possible increase in TSH concentrations

Monitor TSH concentrations more closely

Metoprolol

Pharmacokinetic interaction unlikely

Warfarin

Pharmacokinetic interaction unlikely

Sevelamer 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.

Sevelamer Carbonate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

800 mg

Renvela

Genzyme

Sevelamer Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

400 mg

Renagel

Genzyme

800 mg

Renagel

Genzyme

AHFS DI Essentials™. © Copyright 2022, Selected Revisions January 1, 2009. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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