Prescription Drug Guide

Sevelamer Hcl

SERUM PHOSPHATE REDUCTION FOR DIALYSIS PATIENTS

Renagel^® Tablets

(sevelamer hydrochloride) 400 and 800 mg

[se vel´ a mer]

DESCRIPTION

The active ingredient in Renagel* Tablets is sevelamer hydrochloride, a polymeric phosphate binder intended for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which forty percent of the amines are protonated. It is known chemically as poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is hydrophilic, but insoluble in water. The structure is represented below:Chemical Structure of Sevelamer Hydrochloride

a, b = number of primary amine groups	a + b = 9
c = number of crosslinking groups	c = 1
n = fraction of protonated amines	n = 0.4
m = large number to indicate extended polymer network

The primary amine groups shown in the structure are derived directly from poly(allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly(allylamine hydrochloride) and one molecule of epichlorohydrin.

Renagel^® Tablets : Each film-coated tablet of Renagel contains either 800 mg or 400 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. The tablet imprint contains iron oxide black ink.

*Registered trademark of Genzyme Corporation