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• About Xifaxan550 for Overt HE
• Why Xifaxan550 for Overt HE
• Taking Xifaxan550 for Overt HE

Why Xifaxan550 for overt HE

How can Xifaxan550 help adults living with overt hepatic encephalopathy (HE)?

Studies show Xifaxan 550 mg can reduce your risk of overt HE recurrence and of being hospitalized for HE

A scientific study found that Xifaxan 550 mg can help adults with overt HE who are at least 18 years old and have had HE flare-ups in the past.

Adults in the study took 1 Xifaxan 550 mg pill 2 times a day for 6 months. Almost all of the participants were also taking lactulose—another medicine used to treat overt HE that you may be familiar with (or may be currently taking).

The study found that:

• Xifaxan 550 mg can lower your risk of overt HE recurrence
• Xifaxan 550 mg can reduce your chances of being hospitalized for HE

Learn more about taking Xifaxan 550 mg

Discover the importance of treating overt HE

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