Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
The most frequently occurring (≥ 5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class. Most of these adverse reactions were mild to moderate in intensity.

Tabulated list of 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).
Adverse reactions that occurred during clinical trials or that were spontaneously reported from post- marketing experience are listed by frequency in the table below. The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

MedDRA System Very common                    Common              Very rare           Not known Organ Class
Immune system                                                    Hypersensitivity* disorders
Gastrointestinal Nausea,                     Diarrhoea,                              Intestinal disorders        vomiting,upper              dyspepsia,                              obstruction, abdominal                   flatulence,                             ileus/subileus, pain, constipation          abdominal pain                          intestinal perforation1,
gastrointestinal hemorrhage*1,
intestinal ulceration*1,
gastrointestinal necrosis*1,
colitis*1,
intestinal mass*1
Skin and                                                                             Pruritus, rash subcutaneous tissue disorders
Investigations                                                                       Crystal deposit intestine*1
*Post-marketing experience
1
See inflammatory gastrointestinal disorders warning in section 4.4

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il/