Hepatic encephalopathy (HE) is a disease marked by a cycle of relapse and remission that is difficult to break. All too often, patients can experience a discouraging prognosis and declining quality of life without proper treatment.
HE is a disease marked by an intractable cycle of relapse and remission, followed almost inevitably by relapse. Episodes of acute encephalopathy can be reversed; however, people with chronic liver disease are consistently susceptible to future relapse.1
It is estimated that 50-70% of cirrhotic patients will go on to develop overt HE.2 The more advanced a patient’s liver disease, the more likely the patient will experience an HE episode.3
Furthermore, development of an HE episode is associated with a poor prognosis in patients with liver disease, and, in some cases, a potential predictor of mortality.4,5
HE has a serious negative impact on patients’ quality of life, beyond the detrimental effects already experienced from their underlying liver disease. HE alters patients’ mental health perception and ability to interact and engage with others.6
Patients can find themselves disabled—unable to drive, hold a regular job, or care for themselves independently.3
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%).
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References: 1. Merck Manual Home Edition. http://www.merck.com/mmhe/index.html. Accessed January 7, 2010. 2. Tavares de Melo R, Charneski L, Hilas O. Rifaximin for the treatment of hepatic encephalopathy. Am J Health-Syst Pharm. 2008;65:818-822. 3. Muñoz SJ. Hepatic encephalopathy. Med Clin North Am. 2008; 92(4):795-812. 4. Rama Rao KV, Norenberg MD. Cerebral energy metabolism in hepatic encephalopathy and hyperammonemia. Metab Brain Dis. 2001;16:67-78. 5. Bustamante J, Rimola A, Ventura P-J, et al. Prognostic significance of hepatic encephalopathy in patients with cirrhosis. J Hepatol. 1999;30:890-895. 6. Arguedas MR, DeLawrence TG, McGuire BM. Influence of hepatic encephalopathy on health-related quality of life in patients with cirrhosis. Dig Dis Sci. 2003;48(8):1622-1626.
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