Don’t wait until a patient is hospitalized:
Screen for HE today

Because cirrhosis is such a strong risk factor for overt HE, screening for HE is critical in patients with CLD/cirrhosis.1 Diagnosis requires the detection of signs suggestive of HE in a patient with severe liver insufficiency who does not have obvious alternative causes of brain dysfunction.2

You can help patients at risk of overt HE recurrence by screening today

  • As burden of CLD/cirrhosis increases, frequency of HE increases3,4
  • Disrupt the pattern: screen with West Haven Criteria (Conn score)2

How XIFAXAN is believed to work in overt HE

Gut-derived toxins, such as ammonia, are thought to be central to the pathogenesis of HE.5,6 XIFAXAN is believed to modulate gastrointestinal flora, including Gram +/–, aerobic/anaerobic, and enteric bacteria, which may help decrease production of the nitrogenous compounds associated with the pathogenesis of HE.5,7,8

Align with the Guidelines for patients at risk

XIFAXAN earned AASLD/EASL’s highest possible recommendation (GRADE I,A,1) as an add-on therapy to lactulose to reduce the risk of overt HE recurrence after a patient has a recurrence while on lactulose alone2*

  • Lactulose alone may not be sufficient2,4

*Per the GRADE System for Evidence: Grade I=randomized, controlled trials; A=evidence is “high quality,” and further research is very unlikely to change our confidence in the estimated effect; and 1=recommendation is “strong,” with factors influencing strength of recommendation, including the quality of evidence, presumed patient-important outcomes, and costs.2

Connect to AASLD

AASLD/EASL 2014 Guideline Overview

Quickly review some of the recommendations for adult patients with OHE.

Diagnosing and grading severity of OHE

Diagnosing OHE is a clinical decision based on a clinical examination, requiring the detection of signs suggestive of HE in a patient with severe liver insufficiency and/or portosystemic shunts who does not have obvious alternative causes of brain dysfunction. The recognition of precipitating factors for HE (eg, GI bleeding and infections) supports the diagnosis of HE.2

What do the guidelines say about ammonia?

”Increased blood ammonia alone does not add any diagnostic, staging, or prognostic value for HE in patients with chronic liver disease. A normal value calls for diagnostic reevaluation (GRADE II-3,A,1).” –Recommendation 9

Managing OHE

”Secondary prophylaxis after an episode for OHE is recommended (GRADE I,A,1).” –Recommendation 11

Transition from inpatient care to home care

Ongoing management and team awareness post-discharge is recommended, including educating the patient, caregivers, and providers so that everyone on the care team understands how to manage HE and reduce the risk of repeated HE-related hospitalizations.2

HE = hepatic encephalopathy

CLD = chronic liver disease

GI = gastrointestinal

AASLD = American Association for the Study of Liver Diseases

EASL = European Association for the Study of the Liver

INDICATIONS

XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

IMPORTANT SAFETY INFORMATION
  • XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, 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. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
  • There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
  • Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin.
  • In clinical studies, the most common adverse reactions for XIFAXAN were:
    • HE (≥10%): Peripheral edema (15%), nausea (14%), dizziness (13%), fatigue (12%), and ascites (11%)
    • IBS-D (≥2%): Nausea (3%), ALT increased (2%)
  • INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
  • XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information.

References: 1. Romero-Gómez M, Boza F, García-Valdecasas MS, García E, Aguilar-Reina J. Subclinical hepatic encephalopathy predicts the development of overt hepatic encephalopathy. Am J Gastroenterol. 2001;96(9):2718-2723. 2. American Association for the Study of Liver Diseases. Hepatic encephalopathy in chronic liver disease: 2014 practice guideline by AASLD and EASL. https://www.aasld.org/sites/default/files/2019-06/141022_AASLD_Guideline_Encephalopathy_4UFd_2015.pdf. Accessed April 20, 2020. 3. Peery AF, Crockett SD, Barritt AS, et al. Burden of gastrointestinal, liver, and pancreatic diseases in the United States. Gastroenterology. 2015;149(7):1731-1741. 4. Bajaj JS, Reddy KR, Tandon P, et al. The 3-month readmission rate remains unacceptably high in a large North American cohort of patients with cirrhosis. Hepatology. 2016;64(1):200-208. 5. Vince AJ, Burridge S. Ammonia production by intestinal bacteria: the effects of lactose, lactulose and glucose. J Med Microbiol. 1980;13(2):177-191. 6. Khan A, Ayub M, Khan WM. Hyperammonemia is associated with increasing severity of both liver cirrhosis and hepatic encephalopathy. Int J Hepatol. 2016;2016:6741754. 7. XIFAXAN [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals. 8. Debbia EA, Maioli E, Roveta S, Marchese A. Effects of rifaximin on bacterial virulence mechanisms at supra- and sub-inhibitory concentrations. J Chemother. 2008;20(2):186-194. 9. Data on file. Salix Pharmaceuticals. Bridgewater, NJ.

INDICATIONS

XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

IMPORTANT SAFETY INFORMATION
  • XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, 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. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.