Dosing and uses of Renagel, Renvela (sevelamer)
Adult dosage forms and strengths
tablet
- 400mg
- 800mg
packet
- 800mg
- 2400mg
End-Stage Renal Disease
Hemodialysis; hyperphosphatemia
Initial dose
- Serum PO4 >9 mg/dL [2.91 mmol/L]: 1600 mg PO q8hr with meals
- Serum PO4 7.5-9 mg/dL [2.42-2.91 mmol/L]: 1200-1600 mg PO q8hr with meals
- Serum PO4 5.5-7.5 mg/dL [1.78-2.42 mmol/L]: 800 mg PO q8hr with meals
Maintenance dose
- Serum PO4 >5.5 mg/dL [>1.78 mmol/L]: Increase dose by 400-800 mg per meal
- Serum PO4 3.5-5.5 mg/dL [1.13-1.78 mmol/L]: Maintain current dose
- Serum PO4 <3.5 mg/dL [1.13 mmol/L] decrease by 400-800 mg per meal
Dosing considerations
- Titrate dose; increase by 400-800 mg per meal at 2-week intervals; no more than 4 g
Switching From Ca-Acetate
Substitute 800 mg Renagel or Renvela for 667 mg of Ca-acetate
Substitute 1600 Renvela or Renagel for 1334 mg of Ca-acetate
Substitute 2400 mg Renvela or Renagel for 2001 mg Ca-acetate
Dosing considerations
- Renagel = Renvela on a per gram basis
Pediatric dosage forms and strengths
Safety and efficacy not established
Renagel, Renvela (sevelamer) adverse (side) effects
>10%
Vomiting (22%)
Nausea (20%)
Diarrhea (19%)
Dyspepsia (16%)
Nasopharyngitis (14%)
Limb pain (13%)
Pruritus (13%)
Arthralgia (12%)
Bronchitis (11%)
Dyspnea (10%)
Hypertension (10%)
1-10%
Abdominal pain (9%)
Constipation (8%)
Flatulence (8%)
Peritonitis (during peritoneal dialysis: 8%)
Hypercalcemia (5-7%)
Frequency not defined
Back pain
Cough
Headache
Pyrexia
Upper respiratory infection
Pruritus
Rash
Intestinal perforation
Fecal impaction
Intestinal obstruction
Postmarketing Reports
Hypersensitivity
Warnings
Contraindications
Hypersensitivity
Bowel obstruction
Cautions
Caution in dysphagia, GI motility disorders, GI surgery
Bowel obstruction and perforation reported
Tablets should not be crushed, broken, or chewed (tablets rapidly expand and become a choking hazard)
Dysphagia and esophageal tablet retention reported, in some cases requiring hospitalization and intervention; consider sevelamer oral suspension in patients with history of swallowing disorders
May decrease GI absorption of antiarrhythmic, fat soluble vitamins, folic acid, and antiseizure medications; take medications 1 hour before or 3 hours after sevelamer dose
Monitor fat soluble vitamin and folic acid levels, especially in pregnancy
Safety/efficacy with dialysis not studied
Pregnancy and lactation
Pregnancy category: C
Lactation: Not absorbed systemically; not excreted in breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Renagel, Renvela (sevelamer)
Mechanism of action
Polymeric phosphate binder; decreases serum phosphate concentrations without changing calcium, aluminum, or bicarbonate concentrations
Absorption
No intestinal absorption
Elimination
Excretion: Feces
