Renvela For Oral Suspension

— THERAPEUTIC CATEGORIES —
  • Hyperphosphatemia
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Renvela For Oral Suspension Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Sevelamer carbonate 0.8g, 2.4g; per packet; pwd for oral susp.

    Pharmacological Class

    Phosphate binder.

    See Also

    How Supplied

    Tabs—30, 270; Packets—90

    How Supplied

    Renvela Powder for Oral Suspension

    • Supplied as opaque, foil-lined, heat-sealed, packets containing 0.8 g or 2.4 g of sevelamer carbonate on an anhydrous basis.

    • 1 Box of 90-count 2.4 g packets.

    • 1 Box of 90-count 0.8 g packets.

    Storage

    Store at 25°C (77°F): excursions permitted to 15°C-30°C (59°F-86°F).

    Manufacturer

    Sanofi Genzyme Company

    Mechanism of Action

    Renvela contains sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum (serum phosphorus).

    Renvela For Oral Suspension Indications

    Indications

    Control of serum phosphorus in patients ≥6yrs with chronic kidney disease on dialysis.

    Renvela For Oral Suspension Dosage and Administration

    Adult

    Take with meals. Mix with 30mL (0.8g packet) or 60mL (2.4g packet) of water; drink mixture within 30mins. Patients not taking a phosphate binder: serum phosphorus >5.5 and <7.5mg/dL: 800mg 3 times daily; ≥7.5mg/dL: 1.6g 3 times daily. Titrate by 800mg/meal at 2-week intervals to serum phosphorus target range; average max 7.2g/day. Switching from sevelamer HCl or switching between sevelamer carbonate tabs and pwd: use same dose in grams. Switching from calcium acetate: sevelamer carbonate 800mg approximates calcium acetate 667mg (see full labeling).

    Adult

    • Take with meals. 

    • Starting dose for adult patients not taking a phosphate binder: 

      • Serum phosphorus >5.5 and <7.5mg/dL: 800mg 3 times daily.

      • Serum phosphorus ≥7.5mg/dL: 1.6g 3 times daily. 

    • Titrate by 800mg/meal at 2-week intervals to serum phosphorus target range; average max 7.2g/day. 

    • Switching from sevelamer HCl or switching between sevelamer carbonate tabs and pwd: use same dose in grams. 

    • Starting dose for dialysis patients switching from calcium acetate to Renvela: 

      • 1 tablet of calcium acetate 667mg = Renvela 0.8g.

      • 2 tablets of calcium acetate 667mg = Renvela 1.6g.

      • 3 tablets of calcium acetate 667mg = Renvela 2.4g.

    Children

    <6yrs: not established. ≥6yrs: Take with meals. Mix with 30mL (0.4g or 0.8g packet) or 60mL (2.4g packet) of water; drink mixture within 30mins. Patients not taking a phosphate binder: BSA: ≥0.75–<1.2m2: 800mg 3 times daily; titrate by 400mg/dose at 2-week intervals to achieve target levels; ≥1.2m2: 1.6g 3 times daily; titrate by 800mg/dose at 2-week intervals to achieve target levels.

    Children

    • <6yrs: not established. 

    • ≥6yrs: Take with meals. 

    • Starting dose for pediatric patients not taking a phosphate binder: 

      • BSA: ≥0.75–<1.2m2: 800mg 3 times daily; titrate by 400mg/dose at 2-week intervals to achieve target levels.

      • BSA: ≥1.2m2: 1.6g 3 times daily; titrate by 800mg/dose at 2-week intervals to achieve target levels.

    • Switching from sevelamer HCl or switching between sevelamer carbonate tabs and pwd: use same dose in grams. 

    • Starting dose for dialysis patients switching from calcium acetate to Renvela: 

      • 1 tablet of calcium acetate 667mg = Renvela 0.8g.

      • 2 tablets of calcium acetate 667mg = Renvela 1.6g.

      • 3 tablets of calcium acetate 667mg = Renvela 2.4g.

    Renvela For Oral Suspension Contraindications

    Contraindications

    Bowel obstruction.

    Renvela For Oral Suspension Boxed Warnings

    Not Applicable

    Renvela For Oral Suspension Warnings/Precautions

    Warnings/Precautions

    Dysphagia. Swallowing disorders (use susp. form). Severe GI motility disorders. Major GI tract surgery. Pregnancy.

    Warnings/Precautions

    Gastrointestinal Adverse Events

    • Consider using sevelamer suspension in patients with a history of swallowing disorders.

    • Re-evaluate Renvela treatment in patients who develop severe gastrointestinal (GI) symptoms.

    • In clinical trials of Renvela, patients with dysphagia, swallowing disorders, severe GI motility disorders, including severe constipation, or major GI tract surgery were not included.

    • Cases of bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation have also been reported with sevelamer use

    Reductions in Vitamins D, E, K (clotting factors) and Folic Acid Levels

    • Risk for reductions in vitamins D, E, and K and folic acid levels.

    Pregnancy Considerations

    Risk Summary

    • Sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. 

    Clinical Considerations

    • Sevelamer carbonate may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women.

    Nursing Mother Considerations

    Risk Summary

    • Renvela is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to Renvela.

    Clinical Considerations

    • Sevelamer carbonate may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women.

    Pediatric Considerations

    • The safety and efficacy of Renvela in lowering serum phosphorus levels was studied in patients 6 years of age and older with CKD. 

    • Renvela has not been studied in pediatric patients below 6 years of age.

    Renvela For Oral Suspension Pharmacokinetics

    See Literature

    Renvela For Oral Suspension Interactions

    Interactions

    Concomitant with drugs that have a narrow therapeutic index; monitor. Consider separation of administration with cyclosporine, tacrolimus, or levothyroxine. Separate dosing of ciprofloxacin by ≥2hrs before or 6hrs after sevelamer; mycophenolate mofetil by ≥2hrs before sevelamer.

    Renvela For Oral Suspension Adverse Reactions

    Adverse Reactions

    Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, constipation; rare: bowel obstruction, perforation.

    Renvela For Oral Suspension Clinical Trials

    Clinical Trials

    Cross-Over Study of Sevelamer Carbonate (Renvela) 800 mg Tablets and Sevelamer Hydrochloride (Renagel) 800 mg Tablets

    • The double-blind, active-controlled, cross-over clinical study included Stage 5 CKD patients (n=79) on hemodialysis who entered into a 5-week sevelamer hydrochloride run-in period, then were randomly assigned to receive either sevelamer carbonate 800mg tablets and sevelamer hydrochloride 800mg tablets for 8 weeks each, with no intervening washout. At the end of each of the 2 cross-over periods, the phosphorus levels were similar.

    Cross-Over Study of Sevelamer Carbonate (Renvela) Powder and Sevelamer Hydrochloride (Renagel) Tablets

    • The clinical study included Stage 5 CKD patients on hemodialysis who entered a 4-week sevelamer hydrochloride run-in period, then were randomly assigned to receive either sevelamer carbonate powder and sevelamer hydrochloride tablets for 4 weeks each with no intervening washout. At the end of each of the 2 cross-over periods, the phosphorus levels were similar.

    Clinical Study of Sevelamer Carbonate (Renvela) Powder and Tablets in Pediatric Patients

    • The clinical study included 101 patients 6 to 18 years of age with CKD on a phosphate binder. Patients were entered into a 2-week, double-blind, fixed-dose period (FDP) in which they were randomly assigned to receive sevelamer carbonate or placebo, and a 26-week, open-label, sevelamer carbonate dose titration period (DTP).

    • Sevelamer carbonate significantly reduced serum phosphorus through Week 2 (primary endpoint) by an LS Mean difference of -0.90 (SE 0.27) mg/dL compared to placebo (P =.001). A similar treatment response was observed in patients who received sevelamer carbonate during the 6-month open-label DTP. Approximately 30% of subjects reached their target serum phosphorus.

    Sevelamer Hydrochloride versus Active-Control, Cross-Over Study in Hemodialysis Patients

    • The clinical study included 84 CKD patients on hemodialysis who were hyperphosphatemic (serum phosphorus >6.0 mg/dL). After a 2-week phosphate binder washout period, patients were randomly assigned in a cross-over design to receive either sevelamer hydrochloride and active control for 8 weeks each. Over each 8-week treatment period, at 3 separate time points the dose of sevelamer hydrochloride could be titrated up to control serum phosphorus.

    • Both treatments significantly decreased mean serum phosphorus by about 2 mg/dL. The median response is a reduction of about 2 mg/dL in both groups. About 50% of subjects have reductions between 1 and 3 mg/dL.

    Sevelamer Hydrochloride versus Active Control in Hemodialysis Patients

    • The clinical study included 200 CKD patients on hemodialysis who were hyperphosphatemic (serum phosphorus >5.5 mg/dL). After a 2-week phosphate binder washout period, patients were randomly assigned to receive either sevelamer hydrochloride 800mg tablets or an active control. 

    • Sevelamer and active control achieved a significant decrease in mean serum phosphorus at week 52.

    Sevelamer Hydrochloride versus Active Control in Peritoneal Dialysis Patients

    • The clinical study included 143 patients on peritoneal dialysis who were hyperphosphatemic (serum phosphorus >5.5 mg/dL). After a 2-week phosphate binder washout period, patients were randomly assigned to receive either sevelamer hydrochloride or an active control open label for 12 weeks. 

    • At the end of treatment, the average daily sevelamer hydrochloride dose was 5.9g (range, 0.8 to 14.3g).

    • Sevelamer achieved statistically significant changes in serum phosphorus of -1.6 mg/dL (P <.001) which was similar to the active control.

    Renvela For Oral Suspension Note

    Not Applicable

    Renvela For Oral Suspension Patient Counseling

    See Literature

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