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warnings and cautions
5 WARNINGS AND PRECAUTIONS IBD Flare: Avoid use in patients with IBD flare ( 5.1 ) Iron Overload: Do not administer to patients with iron overload or those receiving intravenous iron. ( 5.2 ) Risk of Overdosage in Children Due to Accidental Ingestion: Keep out of reach of children. ( 5.3 ) 5.1 Increased Risk of Inflammatory Bowel Disease (IBD) Flare Avoid use of ACCRUFER in patients with an active inflammatory bowel disease (IBD) flare, as there is potential risk of increased inflammation in the gastrointestinal tract. 5.2 Iron Overload Excessive therapy with iron products can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Do not administer ACCRUFER to patients with evidence of iron overload or patients receiving intravenous iron [see Contraindications ( 4 )] . Assess iron parameters prior to initiating ACCRUFER and monitor iron parameters while on therapy [see Overdosage ( 10 ) and Clinical Pharmacology ( 12.2 )] . 5.3 Risk of Overdosage in Children Due to Accidental Ingestion Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Inflammatory Bowel Disease Flare [see Warnings and Precautions ( 5.1 )] Iron Overload [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (incidence > 1%) are flatulence, diarrhea, constipation, feces discolored, abdominal pain, nausea, vomiting and abdominal discomfort/distension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Shield Therapeutics Inc at 1-888-963-6267 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 adult 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 ( 14 )] 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 AEGIS1/2 and AEGIS 3) ACCRUFER 30 mg Twice Daily (N = 175) Placebo (N = 120) Body System Adverse Reaction Gastrointestinal Flatulence 4.6% 0.0% Diarrhea 4.0% 1.7% Constipation 4.0% 0.8% Feces discolored 4.0% 0.8% Abdominal pain 2.9% 2.5% Nausea 1.7% 0.8% Vomiting 1.7% 0.0% Abdominal discomfort 1.1% 0.0% Abdominal distension 1.1% 0.0% 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). Pediatric Patients with Iron Deficiency Anemia The safety profile of ACCRUFER in pediatric patients was assessed in 24 patients aged 10 to <18 years of age enrolled to the FORTIS trial and treated with ACCRUFER. Overall, the safety profile reported in pediatric patients was consistent with the safety profile reported in adult patients with iron deficiency anemia.