Treat
IBS-Differently A 2-week treatment for IBS-D1: • 10 weeks of relief from abdominal pain and diarrhea (Median; range of 6 to 24 weeks)
• Retreat up to 2 times if symptoms recur
IBS-D=irritable bowel syndrome with diarrhea.
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Study Design: Xifaxan was evaluated in 2438 IBS-D patients. 44% (n=1074) experienced relief from an open-label course of treatment. Relief was defined as experiencing a ≥30% improvement from baseline in the weekly average abdominal pain score (based on daily self reports) and a ≥50% reduction in the number of days in a week with a daily stool consistency of Bristol Stool Scale type 6 or 7 compared with baseline. If patients experienced a recurrence of either of their symptoms for 3 weeks of a rolling 4-week period, they entered the randomized, double-blind treatment phase. Randomized patients then received a repeat treatment with either Xifaxan or placebo. The primary endpoint was the proportion of patients who experienced relief in both symptoms (defined exactly as in the open-label period) during the 4 weeks following repeat treatment.1
INDICATION XIFAXAN (rifaximin) 550 mg tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. IMPORTANT SAFETY INFORMATION • XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis. • Clostridium difficile-associated diarrhea (CDAD) has been reported with use of antibacterial agents, including XIFAXAN, and may range in severity
from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to XIFAXAN.
• There is an increased systemic exposure in patients with severe (Child-Pugh Class • XIFAXAN may cause fetal harm. C) hepatic impairment. Caution should be Discontinue in nursing mothers after exercised when administering XIFAXAN to taking into account the importance of these patients. the drug to the mother. • Exercise caution when administrating XIFAXAN concomitantly with a P-glycoprotein (P-gp) inhibitor such as cyclosporine. Concomitant administration of drugs that are P-gp inhibitors can substantially increase the systemic exposure to XIFAXAN.
Salix Pharmaceuticals 8510 Colonnade Center Drive, Raleigh, NC 27615 The Xifaxan 550 mg product and the Xifaxan trademark are licensed by Alfa Wassermann S.p.A. to Salix Pharmaceuticals or its affiliates. The Gut Guy character is a copyright and trademark of Salix Pharmaceuticals or its affiliates. XIFI.0014.USA.16
• The most common adverse reactions for XIFAXAN in IBS-D were nausea (3%) and increased ALT (2%). Please see brief summary of full Prescribing Information on following page. Reference: 1. Xifaxan [prescribing information]. Raleigh, NC: Salix Pharmaceuticals; 2015.
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