NONSYSTEMIC Xifaxan 550 rifaximin 550 mg tablets | Now approved for reduction in risk of overt hepatic encephalopathy recurrence

Enroll in H.E.L.P.

The Hepatic Encephalopathy Living Program (H.E.L.P.) is designed to provide adults* living with overt hepatic encephalopathy (HE) and their caregivers ongoing support for the management of overt HE.

*Only people ≥18 years of age who are at risk of overt HE recurrence are eligible for this program.

Already enrolled in H.E.L.P.?

Enroll in H.E.L.P. and receive a Xifaxan550 Savings Card

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^†You may be contacted by a H.E.L.P. representative to finalize enrollment.

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Are you currently taking the following medicines? (Check all that apply.)

Xifaxan 550 mg or Xifaxan 200 mg
Lactulose (a sweet liquid medicine)
Neomycin
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^‡The Xifaxan550 Savings Card is not available to residents of MA or patients whose prescription plan is paid/partially paid by Medicaid, Medicare, or federal or state government programs. VOID where prohibited by law.

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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.

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