NONSYSTEMIC Xifaxan 550 rifaximin 550 mg tablets | Now approved for reduction in risk of overt hepatic encephalopathy recurrence Xifaxan 550 mg (rifaximin) head and bulb

HE-related hospitalizations

HE-related hospitalizations have increased in the past decade, with little progress on establishing a universal protocol for standard of patient care.*

*HE-related hospitalizations defined as hospitalizations directly resulting from HE or hospitalizations complicated by HE.

Rising number of hospitalizations

HE-related complications are responsible for an estimated one-half to one-third of all hospitalizations for cirrhosis.1 Despite an overall health economic focus on reducing inpatient care, HE-related hospitalizations continue to increase in frequency, along with length of stay.2

Over the past few years, HE-related hospitalizations have steadily increased by over 75%, with 345,887 total discharges in 2009.2

Total Number of Discharges for Hepatic Encephalopathy

*HE-related hospitalizations defined as hospitalizations directly resulting from HE or hospitalizations complicated by HE.
All listed diagnoses at discharge included ICD codes 291.2 (alcoholic dementia, not elsewhere classified), 348.30 (encephalopathy, not otherwise specified), and 572.2 (hepatic coma).

Increasing healthcare costs

This increase in HE hospitalizations comes at a high cost—the average length of stay is 6 days, with mean charges surpassing $35,000 (as of 2009 data).2 Additionally, 40% of patients hospitalized for HE are in the critical care unit, and 22% are discharged to a nursing home or rehabilitation center.2,3 With no universal outpatient protocol for HE, healthcare practitioners may find it difficult to prevent future HE episodes.4-6

See how Xifaxan 550 mg may reduce hospitalizations.

Learn more about Xifaxan 550 mg.

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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.PDF

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. Muñoz SJ. Hepatic Encephalopathy. Med Clin North Am. 2008;92(4):795-812. 2. HCUPnet, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville, MD. http://hcupnet.ahrq.gov. Accessed May 6, 2010. 3. Kim WR, Kamath PS, Shah N. Utilization and outcome of critical care in patients with cirrhosis in the US [abstract 1214]. Hepatology. 2010;52(suppl 1):910A-911A. 4. Blei AT, Cordoba J, Practice Parameters Committee of the American College of Gastroenterology. Practice guidelines: hepatic encephalopathy. Am J Gastroenterol. 2001;96(7):1968-1976. 5. Mathews RE, McGuire B, Estrada CA. Outpatient management of cirrhosis: a narrative review. South Med J. 2006:99(6):600-606. 6. 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.

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