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

Symptoms and stages of HE

What are the signs and symptoms of hepatic encephalopathy (HE)?

HE starts slowly. At first, people with HE may not even know they have it. To them, things seem fine. But things may not seem fine to family or friends.

People with more advanced HE may not be able to drive a car or work a steady job. They may also need to rely on someone else to take care of them. In serious cases, hospitalization and even coma can occur.

Knowing the symptoms of overt HE can help slow it down before it gets worse. If you or a loved one is beginning to show these symptoms or has shown them before, let a doctor know right away.

Mental Signs of HE
Forgetfulness, mild confusion
Poor judgment
Being extra nervous or excited
Not knowing where they are or where they're going
Inappropriate behavior or severe personality changes

Physical Signs of HE
Breath with a musty or
sweet odor
Change in sleep patterns
Worsening of handwriting or loss of other small hand movements
Movements or shaking of hands or arms
Slurred speech
Slowed or sluggish movement

Download the HE symptom tracker form below to help keep track of any HE symptoms you might be experiencing, and bring it to your next doctor's appointment.

Track your symptoms

What are the grades of overt HE?

Overt HE can begin slowly while symptoms gradually worsen, or it can begin suddenly with severe symptoms. The symptoms are graded on a scale from 0 to 4, which is:

No abnormality detected.

Patients appear slightly unaware. They may seem extremely excited or anxious. They have a shortened attention span.

Patients are very tired and may seem indifferent. They keep forgetting where they are and are confused about time. Their personality might change, and they may behave inappropriately.

Patients are extremely sleepy but respond when spoken to. They are confused and severely disoriented.

Coma—the patient is unconscious or unresponsive.

Learn what can cause HE flare-ups

Learn some tips on caring for someone with HE

Discover how Xifaxan 550 mg can help adults living with overt HE

In a randomized, placebo-controlled, double-blind, multicenter, multinational, 6-month study, the efficacy of Xifaxan 550 mg (taken orally 2 times a day) was evaluated in 299 adult subjects. Inclusion criteria: currently in remission (Conn score of 0 or 1) from HE and ≥2 episodes of HE associated with chronic liver disease in the previous 6 months. Lactulose was used concomitantly by 91% of patients (average daily dose of 3.3 cups/day [15 mL/cup]).

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.

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