ACCRUFER SIDE EFFECTS

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Increased Risk of Inflammatory Bowel Disease Flare.
• Iron Overload.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to ACCRUFER in 175 patients in the placebo-controlled phase of three randomized studies conducted in patients with anemia and quiescent inflammatory bowel disease (IBD) (Studies AEGIS 1 & 2) or non-dialysis dependent chronic kidney disease (CKD) (AEGIS 3). The pooled patient population had a mean age of 58 years, 67.4% were female (n=118), and 81.7% (n=143) were Caucasian.

Table 1 presents all adverse reactions occurring in the placebo-controlled period of the pooled randomized studies [see Clinical Studies] occurring at a rate of > 1% in the treated group, and for which the rate for ACCRUFER exceeds the rate for placebo.

Table 1: Adverse Reactions Reported by ≥1% of Patients Treated with ACCRUFER During Placebo-Controlled Period of Pooled Studies (Studies AEGIS 1 & 2 and AEGIS 3)

The proportion of patients who discontinued treatment due to adverse reactions during the double-blind, placebo-controlled portion of studies was 4.6% for patients taking ACCRUFER. The most common adverse reaction leading to discontinuation of ACCRUFER in these studies was abdominal pain (1.7% of patients).