(se VEL a mer)
- Sevelamer Carbonate
- Sevelamer Hydrochloride
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Packet, Oral, as carbonate:
Renvela: 0.8 g (1 ea, 90 ea); 2.4 g (1 ea, 90 ea) [citrus flavor]
Tablet, Oral, as carbonate:
Renvela: 800 mg
Generic: 800 mg [DSC]
Tablet, Oral, as hydrochloride:
Renagel: 400 mg, 800 mg
Brand Names: U.S.
- Phosphate Binder
Sevelamer (a polymeric compound) binds phosphate within the intestinal lumen, limiting absorption and decreasing serum phosphate concentrations without altering calcium, aluminum, or bicarbonate concentrations.
Not systemically absorbed
Onset of Action
Reduction in serum phosphorus has been demonstrated after 1-2 weeks (Burke, 1997; Chertow, 1997).
Use: Labeled Indications
Control of serum phosphorous: Control of serum phosphorous in patients with chronic kidney disease on hemodialysis
Hypersensitivity to sevelamer or any component of the product; bowel obstruction
Note:The dosing of sevelamer carbonate and sevelamer hydrochloride are similar; when switching from one product to another, the same dose (on a mg per mg basis) should be utilized.
Control of serum phosphorous: Oral:
Patients not taking a phosphate binder: 800 to 1,600 mg 3 times daily 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 daily
≥7.5 mg/dL to <9 mg/dL: 1,200 to 1,600 mg 3 times daily
≥9 mg/dL: 1,600 mg 3 times daily
Maintenance dose adjustment based on serum phosphorous concentration (goal range of 3.5 to 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 400 to 800 mg per meal at 2-week intervals
3.5 to 5.5 mg/dL: Maintain current dose
<3.5 mg/dL: Decrease by 400 to 800 mg per meal
Dosage adjustment when switching between phosphate-binder products: 667 mg of calcium acetate is equivalent to ~800 mg sevelamer (carbonate or hydrochloride)
Conversion based on dose per meal:
Calcium acetate 667 mg: Convert to 800 mg Renagel/Renvela
Calcium acetate 1,334 mg: Convert to 1,600 mg as Renagel/Renvela (800 mg tablets x 2) or 1,200 mg as Renagel (400 mg tablets x 3)
Calcium acetate 2,001 mg: Convert to 2,400 mg as Renagel/Renvela (800 mg tablets x 3) or 2,000 mg as Renagel (400 mg tablets x 5)
Refer to adult dosing.
Control of serum phosphorous (off-label use): Oral: In a pilot study of 17 pediatric patients aged 11.8 ± 3.7 years on hemodialysis (n=3) or peritoneal dialysis (n=14), initial doses of 121 ± 50 mg/kg/day (4.5 ± 5 g/day) were used. Doses were adjusted based on the serum phosphorus with final doses of 163 ± 46 mg/kg (6.7 ± 2.4 g/day) without any adverse effects (Mahdavi, 2003). In a study of 18 patients aged 0.9-18 years with chronic kidney disease, a mean dose of 140 ± 86 mg/kg/day (5.38 ± 3.24 g/day) resulted in good phosphorus control with minimal adverse effects. Initial doses were based on prior phosphate-binder dose and were adjusted based on the serum phosphorus (Pieper, 2006).
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer’s labeling.
Powder for oral suspension: Mix powder with water prior to administration. Mix the 0.8 g packet with 30 mL of water and mix the 2.4 g packet with 60 mL of water (multiple packets may be mixed together using the appropriate amount of water).
Administer with meals.
Powder for oral suspension: Stir vigorously to suspend mixture just prior to drinking; powder does not dissolve. Drink within 30 minutes of preparing and resuspend just prior to drinking.
Tablets: Swallow whole; do not crush, chew, or break.
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.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture.
Calcitriol: Sevelamer may decrease the serum concentration of Calcitriol. Monitor therapy
Calcitriol (Systemic): Sevelamer may decrease the serum concentration of Calcitriol (Systemic). Monitor therapy
Cholic Acid: Sevelamer may decrease the absorption of Cholic Acid. Management: Administer cholic acid at least 1 hour before or 4 to 6 hours after administration of any bile acid-binding products, such as sevelamer, to minimize the potential for a significant interaction. Consider therapy modification
CycloSPORINE (Systemic): Sevelamer may decrease the serum concentration of CycloSPORINE (Systemic). Monitor therapy
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. Consider therapy modification
Mycophenolate: Sevelamer may decrease the serum concentration of Mycophenolate. Management: Administer mycophenolate at least 2 hours prior to sevelamer administration. Consider therapy modification
Quinolone Antibiotics: Sevelamer may decrease the absorption of Quinolone Antibiotics. Management: Administer oral quinolones at least 2 hours before or 6 hours after sevelamer. Exceptions: Levofloxacin (Oral Inhalation). Consider therapy modification
Tacrolimus (Systemic): Sevelamer may decrease the serum concentration of Tacrolimus (Systemic). Monitor therapy
Endocrine & metabolic: Metabolic acidosis (children: 34% [Pieper, 2006]); adults: Frequency not defined)
Gastrointestinal: Vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%)
1% to 10%:
Endocrine & metabolic: Hypercalcemia (5% to 7%)
Gastrointestinal: Abdominal pain (9%), constipation (8%), flatulence (8%), peritonitis (peritoneal dialysis: 8%)
Postmarketing and/or case reports: Fecal impaction, intestinal obstruction (rare), intestinal perforation (rare)
Concerns related to adverse effects:
• Gastrointestinal effects: Bowel obstruction and perforation have been reported. Dysphagia and esophageal tablet retention have also been reported with the tablet formulation; consider change to suspension formulation in patients with a history of swallowing disorders
• Gastrointestinal disease: Use with caution in patients with gastrointestinal disorders including dysphagia, swallowing disorders, severe gastrointestinal motility disorders (including severe constipation), or major gastrointestinal surgery.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions for more detailed information
• Vitamins: May cause reductions in vitamin D, E, K, or 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.
Serum chemistries, including bicarbonate and chloride
Serum calcium and phosphorus: Frequency of measurement may be dependent upon the presence and magnitude of abnormalities, the rate of progression of CKD, and the use of treatments for CKD-mineral and bone disorders (KDIGO, 2009):
CKD stage 3: Every 6-12 months
CKD stage 4: Every 3-6 months
CKD stage 5 and 5D: Every 1-3 months
Periodic 24-hour urinary calcium and phosphorus; magnesium; alkaline phosphatase every 12 months or more frequently in the presence of elevated PTH; creatinine, BUN, albumin; intact parathyroid hormone (iPTH) every 3-12 months depending on CKD severity
Pregnancy Risk Factor
Adverse events have been observed in animal reproduction studies. Sevelamer is not absorbed systemically; however, it may cause a reduction in the absorption of some vitamins.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience diarrhea or flatulence. Have patient report immediately to prescriber severe constipation, considerable nausea, significant dyspepsia, or dysphagia (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.