Diagnosis

Because cirrhosis is such a strong risk factor for overt HE,

Screening for HE is critical in patients with CLD/cirrhosis1,2,*

*For patients with severe liver insufficiency with no obvious alternative causes of brain dysfunction, early identification of HE symptoms is important.3

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Dr. Flamm define the need to screen early for HE

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

As the burden of CLD/cirrhosis increases, so do hospital readmissions. HE is a common driver for such readmissions.4

West Haven criteria chart

West Haven criteria chart

Reduce the risk of overt HE recurrence and HE-related hospitalization5

EXPLORE EFFICACY DATA  

Part of a holistic approach to managing HE is considering available guidelines

AASLD recommends the following to identify patients at risk for HE and initiate care (GRADE II-2,A,1)3,*:

  • Identify and treat precipitating factors
  • Seek and treat alternative causes of altered mental status
  • Initiate care for patients with altered consciousness
  • Commence empirical HE treatment

*Per the GRADE System for Evidence: GRADE II-2=cohort or case-control analytic studies; 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.3

Excerpts from guidelines

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.3

“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 93

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

–Recommendation 113

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.3

Patient brochure

AASLD/EASL 2014 Guideline Overview

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

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Caregivers can play a critical part in the management of patients with HE6

Your patients may not exhibit outward signs of HE at the time of their appointments. Therefore, it is important to ask both patients and their caregivers whether they've experienced (or witnessed) any of the symptoms.

One study found caregivers identified

25%of HE episodes7

AASLD, American Association for the Study of Liver Diseases; CLD, chronic liver disease; EASL, European Association for the Study of the Liver; GI, gastrointestinal; HE, hepatic encephalopathy; OHE, overt hepatic encephalopathy.

References: 1. Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the Study of Liver Diseases. Hepatology. 2017;65(1):310-335. 2. 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. 3. Vilstrup H, Amodio P, Bajaj J, et al. Hepatic encephalopathy in chronic liver disease: 2014 practice guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014;60(2):715-735. 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. XIFAXAN. Prescribing information. Salix Pharmaceuticals; 2023. Accessed January 3, 2024. https://shared.salix.com/globalassets/pi/xifaxan550-pi.pdf 6. Hameed B. A primary care guide to the diagnosis and management of overt hepatic encephalopathy. Consultant 360. 2018;58(5):e161. 7. Landis CS, Ghabril M, Rustgi V, et al. Prospective multicenter observational study of overt hepatic encephalopathy. Dig Dis Sci. 2016;61(6):1728-1734. doi:10.1007/s10620-016-4031-7

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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.

XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence 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.
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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 (alone or in combination with lactulose) were:
    HE (≥10%): Peripheral edema (17%), constipation (16%), nausea (15%), fatigue (14%), insomnia (14%), ascites (13%), dizziness (13%), urinary tract infection (12%), anemia (10%), and pruritus (10%)
    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.

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.

XIF.0180.USA.23V2.0