Home » About Xifaxan550

• Long-term Efficacy
• Reduced Hospitalizations
• Long-term Exposure
• Tolerability Profile
• Dosing
• Safety and Side Effects
• FAQs

About Xifaxan550

Xifaxan 550 mg—breaking the cycle of HE recurrence

Xifaxan 550 mg is indicated to reduce the risk of overt hepatic encephalopathy recurrence in patients ≥18 years of age.1

Xifaxan 550 mg regulates the gut flora to break the frustrating cycle of acute encephalopathy recurrence that is common to HE.2

Durable efficacy

• Xifaxan 550 mg reduced the risk of breakthrough HE by 58% vs placebo over a 6-month period.1*
• Xifaxan 550 mg reduced the risk of HE-related hospitalizations by 50% over a 6-month period.1†

Established safety profile

• Nonsystemic Xifaxan 550 mg offers safety and tolerability when used as directed.1

Twice-daily dosing

• Xifaxan 550 mg offers twice-daily dosing.1
• Xifaxan 550 mg can be taken with or without food.1

*P<0.0001 vs placebo; 91% concomitant lactulose use in both arms.
†P=0.0129 vs placebo; 91% concomitant lactulose use in both arms, HE-related hospitalization is defined as hospitalization directly caused by HE, or a hospitalization during which an HE event occured.

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

See how Xifaxan 550 mg may reduce hospitalizations.

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%).

Complete Prescribing Information.

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
Email: Salix@medcomsol.com

References: 1. Xifaxan [prescribing information]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2010. 2. 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.