Note: Sevelamer carbonate and sevelamer hydrochloride are dosed the same on a mg-to-mg basis; when switching between products, use the same dose.
Hyperphosphatemia in chronic kidney disease, treatment:
Note: Use in combination with dietary phosphate restriction (KDIGO 2017). Sevelamer carbonate is preferred in patients with nondialysis-dependent chronic kidney disease or metabolic acidosis due to risk of metabolic acidosis with sevelamer hydrochloride (Quarles 2022).
Oral: Initial: Based on serum phosphorous levels:
>5.5 to <7.5 mg/dL: 800 mg 3 times daily with meals.
7.5 to <9 mg/dL: 1,200 to 1,600 mg 3 times daily with meals.
≥9 mg/dL: 1,600 mg 3 times daily with meals.
Dosage adjustment: Increase or decrease dose by 400 to 800 mg per meal at 2-week intervals as needed to obtain targeted serum phosphorus concentrations; usual dosage range: 800 to 2,400 mg 3 times daily (Quarles 2022; manufacturer’s labeling).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: No dosage adjustment necessary for any degree of kidney dysfunction (not systemically absorbed) (Ref).
Hemodialysis, intermittent (thrice weekly): Unlikely to be dialyzed: No supplemental dose or dosage adjustment necessary (not systemically absorbed) (Ref).
Peritoneal dialysis: Unlikely to be dialyzed: No dosage adjustment necessary (not systemically absorbed) (Ref).
CRRT: No dosage adjustment necessary (not systemically absorbed) (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (not systemically absorbed) (Ref).
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
(For additional information see "Sevelamer: Pediatric drug information")
Note: Phosphate binding capacity: Sevelamer hydrochloride 400 mg binds ~32 mg of phosphate; 800 mg binds ~64 mg of phosphate (Ref).
Hyperphosphatemia:
Sevelamer carbonate (Renvela): Children ≥6 years and Adolescents:
Patients not taking a phosphate binder (Ref):
Initial dose:
BSA ≥0.75 to <1.2 m2: Oral: 800 mg 3 times daily with meals; titrate as needed by 400 mg per dose at 2-week intervals.
BSA ≥1.2 m2: Oral: 1,600 mg 3 times daily with meals; titrate as needed by 800 mg per dose at 2-week intervals.
Dosage adjustment when switching from calcium acetate to sevelamer carbonate: 667 mg of calcium acetate is equivalent to ~800 mg of sevelamer; conversion based on dose per meal:
Calcium acetate 667 mg: Convert to 800 mg sevelamer carbonate.
Calcium acetate 1,334 mg: Convert to 1,600 mg sevelamer carbonate.
Calcium acetate 2,001 mg: Convert to 2,400 mg sevelamer carbonate.
Sevelamer hydrochloride (Renagel):
Infants ≥10 months and Children <2 years: Very limited data: Oral: Mean final dose of 140 ± 86 mg/kg/day (5.38 ± 3.24 g/day) was reported in a small trial (n=18; age range: 10 months to 18 years) to achieve the targeted serum phosphorus level. Initial dosing was based upon prior phosphate binder dose and serum phosphorus concentrations (Ref). In a case report of a 19-month-old, an initial dose of 100 mg/kg/day divided every 8 hours with titration up to 130 mg/kg/day was reported to effectively lower serum phosphorus levels (Ref).
Children ≥2 years and Adolescents: Limited data available: Oral: Initial dose: 400 or 800 mg 3 times daily administered with meals; titrate at monthly intervals in 1,200 mg/day increments (ie, 400 mg at each meal) to target phosphorus level; final mean range: 140 to 163 mg/kg/day (5.38 to 6.7 g/day); dosing based on experience in 46 patients; prior or final comparative calcium salt phosphate-binder dose: 4 ± 3 g/day (Ref).
Dosage adjustment when switching from calcium acetate to sevelamer hydrochloride: 667 mg of calcium acetate is equivalent to ~800 mg of sevelamer; conversion based on dose per meal.
Renal failure; pretreatment of oral and enteral nutrition formula, expressed breast milk, or cow's milk to decrease phosphate load: Limited data available: Infants and Children:
Expressed breast milk, infant/enteral formula, or cow's milk: Sevelamer hydrochloride or sevelamer carbonate: Add 800 mg (tablets or powder) to up to 400 mL of breast milk or 100 mL of infant formula, tube feeding, and cow's milk; after the addition of sevelamer, allow to sit for 10 minutes, then decant liquid for feed and leave the precipitate at the bottom. Reported experience has shown a decrease in phosphate of >85% in breast milk, 42% in cow's milk, 48% in tube feeding, and 68% in infant formula (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, adjustment is unnecessary as sevelamer is indicated for use in chronic kidney disease.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Packet, Oral, as carbonate:
Renvela: 0.8 g (1 ea, 90 ea); 2.4 g (1 ea, 90 ea) [citrus flavor]
Generic: 0.8 g (1 ea, 90 ea); 2.4 g (1 ea, 90 ea)
Tablet, Oral, as carbonate:
Renvela: 800 mg
Generic: 800 mg
Tablet, Oral, as hydrochloride:
Renagel: 800 mg
Generic: 400 mg, 800 mg
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Packet, Oral, as carbonate:
Renvela: 0.8 g (90 ea); 2.4 g (90 ea)
Tablet, Oral, as carbonate:
Renvela: 800 mg
Generic: 800 mg
Tablet, Oral, as hydrochloride:
Renagel: 800 mg
Administer with meals.
Powder for oral suspension: May prepare an oral suspension in water using the directed amount of water appropriate for the packet size or may premix the entire content of the packet with a small amount of food or beverage (do not heat or add to heated foods or liquids).
Preparations should be consumed immediately or within 30 minutes. Oral suspension in water may need to be resuspended immediately before drinking.
Tablets: Swallow whole; do not crush, chew, or break.
Oral: Administer with meals. Consider separating administration of oral medications from sevelamer when reduced bioavailability would significantly affect the concomitant medication's safety or efficacy (eg, cyclosporine, tacrolimus, levothyroxine); duration of separation varies based on absorption characteristics and whether it is an immediate-release or extended-release product; monitor clinical response and/or blood concentrations of concomitant medications.
Tablets: Swallow tablets whole; do not break, chew, or crush; contents will expand with water.
Powder for oral suspension (sevelamer carbonate): Administer reconstituted oral suspension immediately or within 30 minutes; oral suspension may need to be resuspended immediately before drinking. Alternatively, the powder contents of the packet may be premixed with a small amount of food or beverage and consumed immediately (or within 30 minutes) as part of a meal. Do not heat or add to heated food or liquid.
Hyperphosphatemia in chronic kidney disease, treatment: Control of serum phosphorous in patients with chronic kidney disease (CKD) on hemodialysis.
Note: Based on the Kidney Disease: Improving Global Outcome guideline update for the diagnosis, evaluation, prevention, and treatment of CKD–mineral and bone disorder (CKD-MBD), sevelamer may also be used to control serum phosphorous in patients with grades 3 to 5 CKD not on hemodialysis who exhibit progressively or persistently elevated serum phosphate levels (KDIGO 2017).
Renagel may be confused with Reglan, Regonol, Renvela
Renvela may be confused with Reglan, Regonol, Renagel
Sevelamer may be confused with Savella
Renagel [US, Canada, and multiple international markets] may be confused with Remegel brand name for aluminium hydroxide and magnesium carbonate [Netherlands] and for calcium carbonate [Hungary, Great Britain and Ireland] and with Remegel Wind Relief brand name for calcium carbonate and simethicone [Great Britain]
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Endocrine & metabolic: Metabolic acidosis (children: 34% [Pieper 2006]; adults: Frequency not defined)
Gastrointestinal: Diarrhea (19%), dyspepsia (16%), nausea (20%), vomiting (22%)
1% to 10%: Gastrointestinal: Abdominal pain (9%), constipation (8%), flatulence (8%), peritonitis (peritoneal dialysis: 8%)
Postmarketing:
Dermatologic: Pruritus, skin rash
Gastrointestinal: Colitis, dysphagia, fecal impaction, gastric ulcer with hemorrhage, gastrointestinal necrosis, gastrointestinal ulcer, intestinal obstruction, intestinal perforation
Hypersensitivity: Hypersensitivity reaction
Hypersensitivity to sevelamer or any component of the formulation; bowel obstruction
Canadian labeling: Additional contraindications (not in US labeling): Hypophosphatemia; active mucosal injury (eg, necrosis, perforation, ulcerative colitis, GI bleeding)
Concerns related to adverse effects:
• GI effects: Bowel obstruction, bleeding GI ulcers, colitis, ulceration, necrosis, and perforation have been reported; consider discontinuation of therapy in patients who develop severe symptoms. 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:
• 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.
In a trial conducted in pediatric patients (n=18; age range: 10 months to 18 years), an increase in metabolic acidosis was noted in patients receiving sevelamer hydrochloride (incidence: 34.4%) (Pieper 2006); in another pediatric trial (n=17; age range: 2 to 18 years), no untoward effects were reported (Mahdavi 2003). Patients should be closely monitored.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Calcitriol (Systemic): Sevelamer may decrease the serum concentration of Calcitriol (Systemic). Risk C: 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. Risk D: Consider therapy modification
CycloSPORINE (Systemic): Sevelamer may decrease the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy
Levothyroxine: Sevelamer may decrease the serum concentration of Levothyroxine. Management: Separate administration of sevelamer and levothyroxine by at least 4 hours to decrease the risk of a significant interaction. Monitor clinical and laboratory response to levothyroxine closely when used together with sevelamer. Risk D: Consider therapy modification
Mycophenolate: Sevelamer may decrease the serum concentration of Mycophenolate. Management: Administer mycophenolate at least 2 hours prior to sevelamer administration. Risk D: Consider therapy modification
Quinolones: Sevelamer may decrease the absorption of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after sevelamer. Risk D: Consider therapy modification
Roxadustat: Sevelamer may decrease the serum concentration of Roxadustat. Management: Administer roxadustat at least 1 hour after the administration of sevelamer. Risk D: Consider therapy modification
Tacrolimus (Systemic): Sevelamer may decrease the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy
May cause reductions in vitamin D, E, K, or folic acid absorption. Management: Must be administered with meals. Consider vitamin supplementation.
Sevelamer is not absorbed systemically; however, it may reduce maternal absorption of fat soluble vitamins and folic acid; supplementation may be needed.
Sevelamer is not absorbed systemically and breastfeeding is not expected to cause exposure to a breastfeeding infant.
Sevelamer may reduce maternal absorption of fat soluble vitamins and folic acid; supplementation may be needed.
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.
Serum chemistries, including bicarbonate and chloride
Serum calcium, phosphorus, and parathyroid hormone (PTH): Frequency of measurement may be dependent upon the presence and magnitude of abnormalities, the rate of progression of chronic kidney disease (CKD), and the use of treatments for chronic kidney disease-mineral and bone disorder (CKD-MBD) (KDIGO 2017):
CKD stage G3a to G3b: Serum calcium and phosphate: Every 6 to 12 months; PTH: Frequency based on baseline level and progression of CKD
CKD stage G4: Serum calcium and phosphate: Every 3 to 6 months; PTH: Every 6 to 12 months
CKD stage G5 and G5D: Serum calcium and phosphate: Every 1 to 3 months; PTH: Every 3 to 6 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 to 12 months depending on CKD severity
Note: Due to the complexity and interdependency of the laboratory parameters used for therapeutic decisions in chronic kidney disease-mineral and bone disorder (CKD-MBD) patients, serial assessments of phosphate, calcium, and parathyroid hormone (PTH) levels should be considered together (KDIGO 2017).
Calcium (total): Adults: 8.5 to 10.5 mg/dL (2.12 to 2.62 mmol/L) (IOM 2011). Avoid hypercalcemia for CKD stages G3a to G5D (KDIGO 2017).
Phosphorus: 2.5 to 4.5 mg/dL (0.81 to 1.45 mmol/L). Lower elevated phosphorus levels toward the normal range for CKD stages G3a to G5D (KDIGO 2017).
PTH:
CKD stage G3a to G5: Optimal PTH level is unknown; evaluate patients with progressively elevated intact PTH levels or if levels are consistently above the normal range (assay-dependent) (KDIGO 2017).
Dialysis patients: Maintain iPTH within 2 to 9 times the upper limit of normal for the assay used (KDIGO 2017).
Sevelamer (a polymeric compound) binds phosphate within the intestinal lumen, limiting absorption and decreasing serum phosphate concentrations without altering calcium, aluminum, or bicarbonate concentrations.
Onset of action: Reduction in serum phosphorus has been demonstrated after 1-2 weeks (Burke 1997; Chertow 1997).
Absorption: Not systemically absorbed
Excretion: Feces
Pack (Renvela Oral)
0.8 g (per each): $21.42
2.4 g (per each): $21.42
Pack (Sevelamer Carbonate Oral)
0.8 g (per each): $11.35 - $19.25
2.4 g (per each): $11.35 - $19.25
Tablets (Renagel Oral)
800 mg (per each): $8.92
Tablets (Renvela Oral)
800 mg (per each): $7.14
Tablets (Sevelamer Carbonate Oral)
800 mg (per each): $0.20 - $6.10
Tablets (Sevelamer HCl Oral)
400 mg (per each): $4.02
800 mg (per each): $7.20 - $8.04
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