Sevelamer

Pronunciation: se-VEL-a-mer
Class: Phosphate binder

Trade Names

Renagel
- Tablets (as hydrochloride) 400 mg
- Tablets (as hydrochloride) 800 mg

Renvela
- Tablets (as carbonate) 800 mg
- Suspension, oral (as carbonate) 0.8 g per packet
- Suspension, oral (as carbonate) 2.4 g per packet

Pharmacology

Decreases intestinal phosphate absorption by binding to phosphate in the GI tract.

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Pharmacokinetics

Absorption

Not systemically absorbed.

Special Populations

No data available.

No data available.

Indications and Usage

Reduction of serum phosphorus in patients with chronic kidney disease who are on hemodialysis.

Unlabeled Uses

Treatment of hyperuricemia in patients undergoing hemodialysis.

Contraindications

Hypophosphatemia or bowel obstruction.

Dosage and Administration

PO Serum phosphate of more than 5.5 and less than 7.5 mg/dL, start with 800 mg 3 times daily with meals. Serum phosphate of at least 7.5 and less than 9 mg/dL, start with 1,200 or 1,600 mg 3 times daily with meals. Serum phosphate of 9 mg/dL or more, start with 1,600 mg 3 times daily with meals.

PO Serum phosphate of more than 5.5 and less than 7.5 mg/dL, start with 800 mg 3 times daily with meals. Serum phosphate 7.5 mg/dL or more, start with 1,600 mg 3 times daily with meals.

PO Start with 800 mg with meals in patients receiving calcium acetate 667 mg with meals. Start with 1,200 or 1,600 mg with meals for patients receiving calcium acetate 1,334 mg with meals. Start with 2,000 or 2,400 mg with meals for patients receiving calcium acetate 2,001 mg with meals.

PO Start with 800 mg with meals in patients receiving calcium acetate 667 mg with meals. Start with 1,600 mg with meals for patients receiving calcium acetate 1,334 mg with meals. Start with 2,400 mg with meals for patients receiving calcium acetate 2,001 mg with meals.

PO Serum phosphorus of more than 5.5 mg/dL, increase by 1 tablet per meal at 2-wk intervals. Serum phosphorus of 3.5 to 5.5 mg/dL, maintain current dose. Serum phosphorus of less than 3.5 mg/dL, decrease by 1 tablet per meal.

PO Titrate dose by 800 mg 3 times daily with meals at 2-wk intervals as necessary.

General Advice

• Administer 3 times daily with meals.
• When administering with any other oral drug for which alteration in blood levels could have a clinically significant effect on safety or efficacy, administer the drug at least 1 h before or 3 h after sevelamer, or consider monitoring blood levels of the drug.
• Use the same dosage in grams when switching from sevelamer hydrochloride to sevelamer carbonate or from sevelamer carbonate tablets to oral suspension.
• Use sevelamer oral suspension within 30 min of mixing or resuspend right before drinking.
• Mix entire contents of 0.8 g packet with 30 mL of water; mix 2.4 g packet with 60 mL of water. Stir vigorously (it does not dissolve).

Storage/Stability

Store at 59° to 86°F. Protect from moisture.

Drug Interactions

Bioavailability of ciprofloxacin may be reduced about 50%, possibly decreasing the clinical effect. If coadministration cannot be avoided, separate the administration by at least 4 h.

Sevelamer may reduce mycophenolic acid plasma concentrations, decreasing the efficacy. Administer sevelamer 2 h after mycophenolate mofetil.

The efficacy of thyroid hormones may be decreased, resulting in hypothyroidism. Separate administration by at least 4 h. Monitor TSH levels and the patient for signs of hypothyroidism.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Pruritus, rash (postmarketing).

GI

Vomiting (22%); nausea (20%); diarrhea (19%); dyspepsia (16%); abdominal pain (9%); constipation, flatulence, peritonitis (8%); fecal impaction, ileus, intestinal obstruction, intestinal perforation (postmarketing).

Precautions

Pregnancy

Category C .

Lactation

Not absorbed systemically.

Children

Safety and efficacy not established.

Elderly

Use with caution, starting at the low end of the dosing range.

GI disorders

Use with caution in patients with dysphagia, swallowing disorders, severe GI motility disorders, or major GI tract surgery.

Vitamin deficiencies

Sevelamer hydrochloride reduced vitamin D, E, and K (coagulation parameters) and folic acid levels in rats and dogs.

Overdosage

Symptoms

None reported.

Patient Information

• Advise patients that medication does not replace diet changes and to continue to adhere to their prescribed diet.
• Advise patient to take each dose with meals to achieve maximum benefit.
• Advise patients to report new onset or worsening of existing constipation.
• Advise patients about medications that should be dosed apart from sevelamer.
• Advise patients that sevelamer oral suspension does not dissolve in water; stir the mixture vigorously and use within 30 min of mixing.

Copyright © 2009 Wolters Kluwer Health.