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

Causes of HE flare-ups

What can cause a hepatic encephalopathy (HE) flare-up?

A recurrent episode of overt HE is sometimes called a flare-up. It is not known for certain why people at risk of overt HE recurrence experience flare-ups, but listed below are several possible triggers.

  • A flare-up of HE can be brought on by:
  • Dehydration—not getting enough water
  • Low levels of salt in the blood (this can happen when you are dehydrated)
  • Bleeding in the stomach and intestines
  • Infections
  • Constipation
  • Drugs that act on the central nervous system
  • Lack of potassium
  • Kidney failure
  • A blocked urinary tract
  • A hepatic portal shunt—this is a tube that is placed in a vein near the liver to relieve pressure
  • Surgery
  • Liver injury from disease or drugs
  • Liver cancer

Learn about the symptoms and stages of HE

Learn about Xifaxan 550 mg and reducing the risk of overt HE flare-ups

Xifaxan 550 mg (rifaximin) quarter-circle

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.PDF

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

Salix Pharmaceuticals, Inc. Advancing Treatment in Gastroenterology
Follow Salix on:
Salix Pharmaceuticals on Facebook Salix Pharmaceuticals on Twitter

Use of this site signifies your agreement to the Terms of Use and Legal Restrictions. Privacy Policy.
©2011 Salix Pharmaceuticals, Inc. All rights reserved. RIF 10/44-7
8510 Colonnade Center Drive, Raleigh NC 27615 U.S.A. T: 866-669-SLXP (7597), F: 919-862-1095