RENVELA- sevelamer carbonate tablet, film coated
Atlantic Biologicals Corps
1 INDICATIONS AND USAGE
? Renvela® (sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
? Starting Dose for Adult Patients Not Taking a Phosphate Binder. The recommended starting dose of Renvela is 0.8 to 1.6 g taken orally with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renvela for adult patients not taking a phosphate binder.
Table 1. Starting Dose for Adult Dialysis Patients Not Taking a Phosphate Binder
Serum Phosphorus Renvela
> 5.5 and < 7.5 mg/dL 0.8 g three times daily with meals
? 7.5 mg/dL 1.6 g three times daily with meals
Dose Titration for Adult Patients Taking Renvela. Titrate the Renvela dose by 0.8 g three times per day with meals at two-week intervals as necessary to achieve target serum phosphorus levels. Based on clinical studies, the average prescribed adult daily dose of sevelamer carbonate is approximately 7.2 g per day. The highest daily adult dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.
DOSAGE FORMS AND STRENGTHS
Tablets: 0.8 g white oval, film-coated, compressed tablets imprinted with "RENVELA 800?
Powder: 0.8 g and 2.4 g pale yellow powder packaged in an opaque, foil lined, heat sealed packet
The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel®). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same.