XIFAXAN significantly reduced the risk of overt he recurrence2†

Primary Endpoint

image show chart of secondary endpoints. HE related hospitalizatins during 6 months of treatment with XIFAXAN (rifaximin).

†Study Design2: In a randomized, placebo-controlled, double-blind, multicenter, multinational, 6-month study, the efficacy of XIFAXAN 550 mg (taken orally twice 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. The primary endpoint was the time to first breakthrough overt HE episode, defined as a marked deterioration in neurological function (an increase of Conn score to grade ≥2 or an increase in Conn score and asterixis grade of 1 each if subject entered study at grade 0). Overt HE hospitalization was a key secondary endpoint.

NNT–4 patients would need to take XIFAXAN 550 mg twice daily for 6 months to reduce the risk of 1 episode of overt HE.3

‡Lactulose was used concomitantly by 91% of patients in both arms of the study.2

XIFAXAN significantly reduced the risk of HE-related hospitalizations2†

In a clinical trial, patients with a history of overt HE were randomized to receive either XIFAXAN and lactulose or lactulose and placebo for 6 months.2†

During that time, 14% of patients taking XIFAXAN and lactulose were hospitalized for HE-related reasons, compared with 23% of patients taking lactulose and placebo.2†

This represents a 50% reduction in the risk of HE-related hospitalizations with XIFAXAN.2†

Secondary Endpoint

image show chart of secondary endpoints. HE related hospitalizatins during 6 months of treatment with XIFAXAN (rifaximin).

†Study Design2: In a randomized, placebo-controlled, double-blind, multicenter, multinational, 6-month study, the efficacy of XIFAXAN 550 mg (taken orally twice 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. The primary endpoint was the time to first breakthrough overt HE episode, defined as a marked deterioration in neurological function (an increase of Conn score to grade ≥2 or an increase in Conn score and asterixis grade of 1 each if subject entered study at grade 0). Overt HE hospitalization was a key secondary endpoint.

NNT–9 patients would need to be treated with XIFAXAN 550 mg twice daily for 6 months to reduce the risk of 1 HE-related hospitalization.3

‡Lactulose was used concomitantly by 91% of patients in both arms of the study.2

Xifaxan has a low number needed to treat3

Compared to other therapeutic classes, the number of patients needed to treat (NNT) to prevent an event was very low.3-6

The information above is not intended to be a comparison of NNT among different therapies but is rather to provide an overview of published data on NNT.

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Manage patients with Xifaxan1

  • 1 tablet twice per day—no dose adjustments or titrations2
  • XIFAXAN can be taken with or without food2
  • §The safety and efficacy of XIFAXAN in HE have not been studied beyond 6 months in randomized, placebo-controlled clinical trials2
  • If patients recover a significant amount of liver function, they may be able to discontinue HE therapy1
Image shows a Rx tablet page with XIFAXAN 550mg one tablet twice daily.

XIFAXAN ADDED TO LACTULOSE IS THE BEST DOCUMENTED REGIMEN ACCORDING TO THE 2014 AASLD/EASL GUIDELINES1||

||To maintain remission in patients who have already experienced one or more overt HE recurrences while on lactulose alone.1

AASLD/EASL 2014 PRACTICE GUIDELINE

High risk of overt HE recurrence1

Once an episode of overt HE has occurred, the risk of another episode in the next 12 months is 40%. After a second episode, the risk of another episode becomes 40% within the next 6 months.1

#Risk of recurrence is cumulative in the given time periods.

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Recurrences may cause persistent neurological dysfunction1

Evidence suggests that overt HE may be associated with persistent cumulative defects in memory and learning.1

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Adding XIFAXAN to lactulose is recommended to reduce the risk of overt HE recurrence1

The guideline recommendation to add rifaximin to lactulose after a recurrence of overt HE (while on lactulose alone) is based on an evidence GRADE of I, A , 1.1**

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Secondary prophylaxis is recommended after an overt HE episode1

The guideline recommends that under circumstances where the precipitating factors have been well controlled (ie, infections and variceal bleeding) or liver or nutritional status improved, prophylactic therapy may be discontinued (GRADE III, C, 2).1††

The safety and efficacy of XIFAXAN in HE has not been studied beyond 6 months in randomized, placebo-controlled clinical trials.2

If patients recover a significant amount of liver function, they may discontinue HE therapy.1

**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 included the quality of evidence, presumed patient-important outcomes, and costs.1

††Per the GRADE System for Evidence: Grade III=evidence is opinions of respected authorities, descriptive epidemiology; C=evidence is “low quality” and further research is likely to have an important impact on the committee’s confidence in the estimate effect and is likely to change the estimate (any change of estimate is uncertain); and 2=recommendation is “weak” with variability in preferences and values, or more uncertainty (recommendation is made with less certainty, higher costs, or resource consumption).1

demonstrated safety profile2

Percentage of HE patients taking XIFAXAN with adverse reactions occurring at an incidence ≥8% in a randomized, double-blind, multicenter trial2†

†Study Design2: In a randomized, placebo-controlled, double-blind, multicenter, multinational, 6-month study, the efficacy of XIFAXAN 550 mg (taken orally twice 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. The primary end point was the time to first breakthrough overt HE episode, defined as a marked deterioration in neurological function (an increase of Conn score to grade ≥2 or an increase in Conn score and asterixis grade of 1 each if subject entered study at grade 0). Overt HE hospitalization was a key secondary endpoint.

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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. XIFAXAN [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals. 3. Bass NM, Mullen KD, Sanyal A, et al. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010;362(12):1071-1081. 4. Wiysonge CS, Bradley H, Mayosi BM, et al. Beta-blockers for hypertension. Cochrane Database Syst Rev. 2007;1:1-39. doi:10.1002/14651858.CD002003.pub2. 5. DeVries JH. Intensified glucose lowering in type 2 diabetes: don't throw the baby out with the bathwater. Diabetologia. 2011;54(3):705-706. 6. Mcelduff P, Jaefarnezhad M, Durrington PN. American, British and European recommendations for statins in the primary prevention of cardiovascular disease applied to British men studied prospectively. Heart. 2006;92(9):1213-1218.

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.

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.