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standards of non-Merck sources.
Medication Safety Issues
Sound-alike/look-alike issues:
Renagel® may be confused with Reglan®, Regonol®, Renal Caps, Renvela®
Renvela® may be confused with Reglan®, Regonol®, Renagel®, Renal Caps
Sevelamer may be confused with Savella™
International issues:
Renagel® may be confused with Remegel® which is a brand name for calcium carbonate in Ireland, Italy, and Great Britain
Pronunciation
(se VEL a mer)
U.S. Brand Names
Index Terms
Generic Available
No
Canadian Brand Names
Pharmacologic Category
Use: Labeled Indications
Reduction or control of serum phosphorous in patients with chronic kidney disease on hemodialysis
Pregnancy Risk Factor
C
Pregnancy Considerations
Animal studies have shown reduced or irregular ossification of fetal bones. Because sevelamer may cause a reduction in the absorption of some vitamins, it should be used with caution in pregnant women.
Lactation
Excretion in breast milk unknown/use caution (not absorbed systemically but may alter maternal nutrition)
Breast-Feeding Considerations
It is not known whether sevelamer is excreted in human milk. Because sevelamer may cause a reduction in the absorption of some vitamins, it should be used with caution in nursing women.
Contraindications
Hypophosphatemia; bowel obstruction
Warnings/Precautions
Disease-related concerns:
• Gastrointestinal disease: Use with caution in patients with gastrointestinal disorders including dysphagia, swallowing disorders, severe gastrointestinal motility disorders (including constipation), or major gastrointestinal surgery.
Concurrent drug therapy issues:
• Gastrointestinal binding: Sevelamer may bind to some drugs in the gastrointestinal tract and decrease their absorption. When changes in absorption of oral medications may have significant clinical consequences (such as antiarrhythmic and antiseizure medications), these medications should be taken at least 1 hour before or 3 hours after a dose of sevelamer.
• Vitamins: May cause reductions in vitamin D, E, K, and folic acid absorption.
Dosage form specific issues:
• Tablets: Should not be taken apart or chewed; broken or crushed tablets will rapidly expand in water/saliva and may be a choking hazard.
Adverse Reactions
Note: A decreased incidence of gastrointestinal adverse events was observed in a clinical trial of sevelamer carbonate compared to sevelamer hydrochloride.
>10%:
Dermatologic: Pruritus (13%)
Gastrointestinal: Vomiting (22%), nausea (7% to 20%), diarrhea (4% to 19%), dyspepsia (5% to 16%)
Neuromuscular & skeletal: Limb pain (13%), arthralgia (12%)
Respiratory: Nasopharyngitis (14%), bronchitis (11%)
1% to 10%:
Cardiovascular: Hypertension (10%)
Central nervous system: Headache (9%), pyrexia (5%)
Endocrine & metabolic: Hypercalcemia (5% to 7%)
Gastrointestinal: Abdominal pain (9%), flatulence (4% to 8%), constipation (2% to 8%)
Neuromuscular & skeletal: Back pain (4%)
Respiratory: Dyspnea (10%), cough (7%), upper respiratory tract infection (5%)
Miscellaneous: Peritonitis (peritoneal dialysis: 8%)
Postmarketing and/or case reports: Fecal impaction, ileus (rare), intestinal obstruction (rare), intestinal perforation (rare), rash
Drug Interactions
Levothyroxine: Sevelamer may decrease the serum concentration of Levothyroxine. Management: Consider separating administration of sevelamer and levothyroxine by at least several hours whenever possible in order to decrease the risk of a significant interaction. Risk D: Consider therapy modification
Mycophenolate: Sevelamer may decrease the serum concentration of Mycophenolate. Risk D: Consider therapy modification
Quinolone Antibiotics: Sevelamer may decrease the absorption of Quinolone Antibiotics. Risk D: Consider therapy modification
Storage
Store at controlled room temperature of 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture.
Mechanism of Action
Sevelamer (a polymeric compound) binds phosphate within the intestinal lumen, limiting absorption and decreasing serum phosphate concentrations without altering calcium, aluminum, or bicarbonate concentrations. Increased serum bicarbonate levels have been observed with the use of sevelamer carbonate, compared to sevelamer hydrochloride.
Pharmacodynamics/Kinetics
Absorption: Not systemically absorbed
Excretion: Feces
Dosage
Oral: Note: The dosing of sevelamer carbonate and sevelamer hydrochloride are expected to be similar, when switching from one product to another, the same dose (on a mg per mg basis) should be utilized.
Children (unlabeled use): Sevelamer hydrochloride: Doses of 121-163 mg/kg/day divided 3 times/day given with meals have been used in small studies. Doses should be rounded to nearest tablet size.
Maintenance dose adjustment based on serum phosphorous concentration (based on age).
Adults: Patients not taking a phosphate binder: 800-1600 mg 3 times/day with meals; the initial dose may be based on serum phosphorous levels:
>5.5 mg/dL to <7.5 mg/dL: 800 mg 3 times/day
?7.5 mg/dL to <9.0 mg/dL: 1200-1600 mg 3 times/day
?9.0 mg/dL: 1600 mg 3 times/day
Maintenance dose adjustment based on serum phosphorous concentration (goal range of 3.5-5.5 mg/dL; maximum dose studied was equivalent to 13 g/day [sevelamer hydrochloride] or 14 g/day [sevelamer carbonate]):
>5.5 mg/dL: Increase by 1 tablet per meal at 2-week intervals
3.5-5.5 mg/dL: Maintain current dose
<3.5 mg/dL: Decrease by 1 tablet per meal
Dosage adjustment when switching between phosphate binder products: 667 mg of calcium acetate is equivalent to 800 mg sevelamer (carbonate or hydrochloride)
Administration: Oral
Must be administered with meals. Tablets should be swallowed whole; do not crush, chew, or break.
Monitoring Parameters
Serum chemistries, including phosphorus, calcium, bicarbonate, chloride
Dietary Considerations
Take with meals. Reduced levels of folic acid, and vitamins D, E, and K may occur; most hemodialysis patients in clinical trials received vitamin supplementation.
Patient Education
Take as directed, with meals. Do not break or chew tablets (contents will expand in water). You may experience headache or dizziness (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, or heartburn (small frequent meals, frequent mouth care, or sucking hard candy may help); diarrhea; itching; or mild neuromuscular pain or stiffness (mild analgesic may help). Report persistent adverse reactions. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.
Geriatric Considerations
No specific dose changes needed for the elderly. Since electrolyte changes (ie, phosphorus, calcium) can have dramatic effects in the elderly, monitor closely.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Assess knowledge/teach patient appropriate use, possible side effects/interventions, and adverse symptoms to report. Monitor blood pressure.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, as carbonate:
Renvela®: 800 mg
Tablet, as hydrochloride:
Renagel®: 400 mg, 800 mg
Pricing: U.S. (www.drugstore.com)
Tablets (Renagel)
400 mg (180): $248.74
800 mg (30): $93.74
References
Delmez J, Block G, Robertson J, et al, “A Randomized, Double-Blind, Crossover Design Study of Sevelamer Hydrochloride and Sevelamer Carbonate in Patients on Hemodialysis,” Clin Nephrol, 2007, 68(6):386-91.
Mahdavi H, Kuizon BD, Gales B, et al, “Sevelamer Hydrochloride: An Effective Phosphate Binder in Dialyzed Children,” Pediatr Nephrol, 2003, 18(12):1260-4.
Pieper AK, Haffner D, Hoppe B, et al, “A Randomized Crossover Trial Comparing Sevelamer With Calcium Acetate in Children With CKD,” Am J Kid Dis, 2006, 47(4):625-35.
Storms LE, Chicella MF, and Dice JE, “Sevelamer Therapy for Pediatric End-Stage Renal Disease,” Pharmacotherapy, 2006, 26(3):410-13.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2009
Content last modified August 2009
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