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About HE

7 things to remember about HE

1. Anyone with liver damage can have hepatic encephalopathy (HE), but mostly it happens to people who have cirrhosis, a condition that affects the way the liver works.
2. HE seems to be caused by toxins that build up in the blood and then get to the brain.
3. Symptoms of HE can start slowly and may not be noticed at first. To monitor mental and physical symptoms, download the HE Symptom Tracker.
4. Overt HE will not get better on its own, and symptoms will likely get worse without treatment. Talk to your doctor about treatment options.
5. Treatments for overt HE aim to reduce the recurrence of the disease and keep people from being admitted to the hospital because of an HE episode.
6. Xifaxan 550 mg can be prescribed by a doctor to reduce the risk of overt HE recurrence. Be sure to follow all of the dosing instructions given by a doctor, and always take medications as directed.
7. H.E.L.P.—the HE Living Program provides support for adults living with overt HE and for their caregivers. Learn more about H.E.L.P. and how you can save on your Xifaxan 550 mg prescription.

Learn more about taking Xifaxan 550 mg

Learn how to reduce the risk of overt HE recurrence with
Xifaxan 550 mg

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