ID (N=73) for 24 weeks. The initial dose for the two groups was 4.8 g/day. At the end of the study, the total daily dose was 6.2 ± 2.6 g/day of sevelamer carbonate powder QD and 6.7 ± 3.0 g/day of sevelamer hydrochloride tablets TID. A greater percentage of subjects on the once daily dose than TID regimen discontinued therapy prematurely, 35% versus 15%. The reasons for discontinuation were largely driven by adverse events and withdrawal of consent in the once daily dosing regimen. Serum phosphate levels and calcium-phosphate product were better controlled on the TID regimen than on the QD regimen. Mean serum phosphorus decreased 2.0 ± 1.8 mg/dL for sevelamer carbonate powder QD and 2.9 ± 1.3 mg/dL for sevelamer hydrochloride tablets TID.
16 HOW SUPPLIED/STORAGE AND HANDLING
Tablets: Renvela® 800 mg Tablets are supplied as white oval, film-coated, compressed tablets, imprinted with “RENVELA 800”, containing 800 mg of sevelamer carbonate on an anhydrous basis, microcrystalline cellulose, hypromellose, diacetylated monoglycerides, sodium chloride, and zinc stearate.
1 Box Unit Dose of 30 ct 800 mg Tablets (NDC 0179-0043-70)
Storage: Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F).
[See USP controlled room temperature]
Protect from moisture.
17 PATIENT COUNSELING INFORMATION
17.1 Dosing
Inform patients to take Renvela as directed with meals and adhere to their prescribed diets.
For patients using an oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, advise the patient to take the drug at least one hour before or three hours after Renvela but blood tests may be necessary to determine if there is a significant interaction between the drugs.
17.2 Adverse Reactions
Renvela may cause constipation that if left untreated, may lead to severe complications. Patients should be cautioned to report new onset or worsening of existing constipation promptly to their physician.
Renvela®
sevelamer carbonate
tablets
800 mg
30 film-coated tablets in 1 Box, Unit Dose NDC 0179-0043-70
Rx Only
Manufactured by:
Genzyme Ireland Ltd.
For: Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142 USA
Repackaged by:
KAISER FOUNDATION HOSPITALS
Livermore, CA 94551
Package Label
