About HE

What is HE?

Hepatic encephalopathy (HE) is a brain dysfunction caused by liver insufficiency and/or portosystemic shunting.1

In patients with cirrhosis and decreased hepatic function, toxins from the gut can enter the bloodstream and reach the brain, where they affect neurotransmission.1-3 This can cause episodes of HE, which may present as alterations in consciousness, cognition, and behavior that range from minimal to severe.1-3

CLD and cirrhosis are a growing problem4

  • Greater Mortality

    Greater mortality

    CLD and cirrhosis had greater mortality in patients aged 25 to 54 than diabetes or cerebrovascular disease (2019)5

  • Hospitalizations

    Increase in hospitalizations

    45% increase in total number of CLD-related hospitalizations from 2005 to 20176,*

  • Cause of Death

    9th leading cause of death

    CLD and cirrhosis were the 9th leading cause of death in the US in 20217

Patients with CLD/decompensated cirrhosis who have portal hypertension have a higher risk of complications, such as8,9:

  • HE

    HE

  • Varices

    Varices

  • Ascites

    Ascites

HE is a primary complication of cirrhosis1

Up to
80%
of patients with cirrhosis will eventually develop some form of HE1
SCREEN CIRRHOSIS PATIENTS

*Rates per 1000 persons.

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Dr. Flamm discuss how to recognize patients at risk for HE

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The risk of overt HE recurrence is high1

Once overt HE occurs, patients have a high risk of recurrence1:

40%

cumulative risk
  • of an overt HE recurrence at 1 year
  • of another overt HE recurrence within 6 months, despite standard-of-care treatment

HE and overt HE can be a burden for patients and families

  • HE is a progressive disease associated with both mental and physical symptoms1
  • Multiple episodes of OHE are associated with persistent deficits in: working memory, response inhibition, reaction time, divided attention10

CLD, chronic liver disease.

References: 1. 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. 2. Vince AJ, Burridge SM. Ammonia production by intestinal bacteria: the effects of lactose, lactulose and glucose. J Med Microbiol. 1980;13(2):177-191. 3. 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. 4. Hirode G, Saab S, Wong RJ. Trends in the burden of chronic liver disease among hospitalized US adults. JAMA Netw Open. 2020;3(4):e201997. 5. Xu J, Murphy SL, Kochanek KD, Arias E. Deaths: final data for 2019. Natl Vital Stat Rep. 2021;70(8):1-87. doi:10.15620/cdc:106058 6. Desai AP, Greene M, Nephew LD, et al. Contemporary trends in hospitalizations for comorbid chronic liver disease and substance use disorders. Clin Transl Gastroenterol. 2021;12(6):e00372. doi:10.14309/ctg.0000000000000372 7. Chronic liver disease and cirrhosis. Centers for Disease Control and Prevention. Updated January 17, 2023. Accessed January 4, 2024. https://www.cdc.gov/nchs/fastats/liver-disease.htm 8. Mansour D, McPherson S. Management of decompensated cirrhosis. Clin Med (Lond). 2018;18(suppl 2):s60-s65. doi:10.7861/clinmedicine.18-2-s60 9. 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. doi:10.1002/hep.28906 10. Bajaj JS, Schubert CM, Heuman DM, et al. Persistence of cognitive impairment after resolution of overt hepatic encephalopathy. Gastroenterology. 2010;138(7):2332-2340.

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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.0179.USA.23V3.0