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

Importance of treating overt HE

How important is it to treat overt hepatic encephalopathy (HE)?

It is unlikely that symptoms of HE will get better on their own. Talking to your doctor about any warning signs is the first step in preventing flare-ups.

Overt HE is not one of those diseases that is cured once you take medicine. Overt HE must be taken care of every day. If your doctor gives you a medicine for overt HE, you should take it as directed.

How is overt HE treated?

Part of the treatment for overt HE is to fix the things that can be fixed, and there are simple steps you can take to help reduce the risk of a flare-up.

  • Your doctor may have you:
  • Drink more nonalcoholic liquids, if you're dehydrated
  • Raise your sodium and potassium levels (these are salts your body needs)
  • Get treatment for certain infections
  • Stop taking certain drugs
  • Get treatment for any urinary blockages

Your diet may also have to change. If you are eating too much protein, you may be told to eat less protein that comes from meat. The doctor will tell you the best way to handle your protein intake.

Learn how to reduce the risk of overt HE recurrence

Learn what can cause HE flare-ups

Learn how Xifaxan 550 mg can reduce the risk of 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

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