Kaycel Adverse Reactions

The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks (724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer hydrochloride and 49 with sevelamer carbonate).
The most frequently occurring (≥ 5% of patients) undesirable effects possibly or probably related to sevelamer were all in the gastrointestinal disorders system organ class. Most of these adverse reactions were mild to moderate in intensity. Data possibly or probably related to sevelamer from these studies are listed by frequency in the table below. The reporting rate is classified as very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). (See Table 2.)

Click on icon to see table/diagram/image

Post-marketing experience: In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate.