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Sevelamer

Pronunciation

Pronunciation

(se VEL a mer)

Index Terms

  • Sevelamer Carbonate
  • Sevelamer Hydrochloride

Dosage Forms

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.

  • Renagel
  • Renvela

Pharmacologic Category

  • Phosphate Binder

Pharmacology

Sevelamer (a polymeric compound) binds phosphate within the intestinal lumen, limiting absorption and decreasing serum phosphate concentrations without altering calcium, aluminum, or bicarbonate concentrations.

Absorption

Not systemically absorbed

Excretion

Feces

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

Contraindications

Hypersensitivity to sevelamer or any component of the product; bowel obstruction

Dosing: Adult

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)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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.

Reconstitution

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).

Administration

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.

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.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture.

Drug Interactions

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

Adverse Reactions

>10%:

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%)

<1% (Limited to important or life-threatening): Fecal impaction, hypersensitivity reaction, intestinal obstruction (rare), intestinal perforation (rare)

Warnings/Precautions

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

Disease-related concerns:

• 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.

Monitoring Parameters

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

C

Pregnancy Considerations

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.

Patient Education

• 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, severe nausea, severe vomiting, severe abdominal pain, 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 health care 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.

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