A-Z Drug Facts > Sevelamer Hydrochloride

Sevelamer Hydrochloride / Carbonate

Pronouncation: (se-VEL-a-mer HYE-droe-KLOR-ide/KAR-boe-nate)
Class: Phosphate binder

Trade Names:
Renagel
- Tablets 400 mg
- Tablets 800 mg

Trade Names:
Renvela
- Tablets 800 mg

Pharmacology

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

Pharmacokinetics

Absorption

Studies indicate that sevelamer is not systemically absorbed.

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; bowel obstruction; or hypersensitivity to any component of the product.

Dosage and Administration

Patients Not Taking Phosphate Binders
Adults

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

Switching From Calcium Acetate
Adults

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

Switching From Sevelamer Hydrochloride
Adults

PO In patients switching from sevelamer hydrochloride, prescribe sevelamer carbonate on a gram per gram basis. Titration to the desired phosphate level may be necessary.

Dose titration
Adults

PO Serum phosphorus of more than 5.5 mg/dL, increase 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 1 tablet per meal.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F). Protect from moisture.

Drug Interactions

Ciprofloxacin

Bioavailability of ciprofloxacin may be decreased about 50%, possibly decreasing the clinical effect.

Cyclosporine

Data are conflicting; however, cyclosporine concentrations may be reduced, decreasing the immunosuppressive effects.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypertension (10%).

CNS

Headache (9%).

Dermatologic

Pruritus (13%); rash (postmarketing).

EENT

Nasopharyngitis (14%).

GI

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

Musculoskeletal

Limb pain (13%); arthralgia (12%); back pain (4%).

Respiratory

Bronchitis (11%); dyspnea (10%); cough (7%); upper respiratory tract infection (5%).

Miscellaneous

Mechanical complication of implant (6%); pyrexia (5%).

Precautions

Monitor Sevelamer does not contain calcium or alkali supplementation. Monitor serum calcium, bicarbonate, and chloride levels. Monitor for reduced vitamins D, E, and K (clotting factors), and folic acid levels.

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.

Concomitant therapy

When coadministering an oral medication where reduction in bioavailability would have a clinically significant effect on safety or efficacy, administer that drug at least 1 h before or 3 h after sevelamer. Consider monitoring blood levels when appropriate.

GI disorders

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

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 that dose may be adjusted periodically in order to achieve max benefit.
• Advise patient to take each dose with meals to achieve max benefit. Caution patient that medication swells when exposed to water and to swallow tablets whole and not to chew, crush, break into pieces, or take apart.
• Advise patients to report new onset or worsening of existing constipation.

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