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Reduced hospitalizations

Xifaxan 550 mg helps keep patients out of the woods by reducing the risk of HE-related hospitalizations

In a randomized, placebo-controlled, double-blind, multicenter, multinational, 6-month study, the efficacy of Xifaxan 550 mg (taken orally 2 times a day) was evaluated in 299 adult subjects. Inclusion criteria: currently in remission (Conn score of 0 or 1) from HE and ≥2 episodes of HE associated with chronic liver disease in the previous 6 months. Lactulose was used concomitantly by 91% of patients (average daily dose of 3.3 cups/day [15 mL/cup]).

*HE-related hospitalization defined as hospitalization directly caused by HE or a hospitalization during which an HE event occurred.

Xifaxan 550 mg may keep patients out of the hospital

• In the pivotal clinical trial (N=299), Xifaxan 550 mg reduced the risk of HE-related hospitalizations by 50% over a 6-month period (P=0.0129; HR=0.50)1
• At 6 months, only 14% of patients taking Xifaxan 550 mg (n=140) had experienced HE-related hospitalizations vs 23% with placebo (n=159; 91% concomitant lactulose use in both arms)1

Learn how Xifaxan 550 mg reduces the risk of overt HE recurrence.

Discover twice-daily dosing.

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

Reference: 1. Xifaxan [prescribing information]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2010.