About Xifaxan550 for overt HE
Xifaxan 550 mg—helping to break the cycle of overt HE recurrence
Xifaxan 550 mg is indicated for reduction in risk of overt hepatic encephalopathy recurrence in patients ≥18 years of age.1
Xifaxan 550 mg has an effect on gut flora to break the frustrating cycle of overt hepatic encephalopathy recurrence that is common in HE.2
Durable efficacy
- Xifaxan 550 mg reduced the risk of breakthrough HE by 58% vs placebo over a
6-month period1*
- Xifaxan 550 mg reduced the risk of HE-related hospitalizations by 50% over a
6-month period1†‡
*P<0.0001 vs placebo; 91% concomitant lactulose use in both arms.
†P=0.0129 vs placebo; 91% concomitant lactulose use in both arms.
‡HE-related hospitalization is defined as hospitalization directly caused by HE or a hospitalization during which an HE event occurred.
Established safety profile
Twice-daily dosing
- Xifaxan 550 mg offers twice-daily dosing1
- Xifaxan 550 mg can be taken with or without food1
Learn how Xifaxan 550 mg reduces the risk of overt HE recurrence.
See how Xifaxan 550 mg may reduce hospitalizations.
IMPORTANT SAFETY INFORMATION
XIFAXAN 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥18 years of age. In the trials of XIFAXAN for HE, 91% of the patients were using lactulose concomitantly. XIFAXAN has not been studied in patients with MELD scores >25, and only 8.6% of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C).
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 nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
The most common adverse reactions occurring in >8% of patients in the clinical study were edema peripheral (15%), nausea (14%), dizziness (13%), fatigue (12%), ascites (11%), muscle spasms (9%), pruritus (9%), and abdominal pain (9%).
Xifaxan550 is not available for sale outside the U.S.
Xifaxan550 is licensed by Alfa Wassermann S.p.A. to Salix Pharmaceuticals, Inc.
Complete Prescribing Information.
You are encouraged to report negative side effects to the FDA. Visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
E-mail: Salix@medcomsol.com
References: 1. Xifaxan [prescribing information]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2010. 2. Als-Nielsen B, Gluud LL, Gluud C. Non-absorbable disaccharides for hepatic encephalopathy: systematic review of randomised trials. Br Med J. 2004;328(7447):1046.
