Efficacy

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In a clinical trial of adults with OHE

XIFAXAN cut the risk of OHE recurrence and HE-related hospitalizations in half1,2

OHE recurrences during 6 months of treatment chart

Efficacy was observed early during treatment

OHE recurrences during 6 months of treatment chart-added
HE recurrences and HE-related hospitalizations during 6 months of treatment chart

Efficacy was observed early during treatment

HE recurrences and HE-related hospitalizations during 6 months of treatment chart-two

*Comparison of Kaplan-Meier estimates of event-free curves showed XIFAXAN significantly reduced the risk of HE breakthrough by 58% during the 6-month treatment period.1

91% of patients in the placebo and XIFAXAN groups were on lactulose1

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Study design1,2
  • 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 patients
  • 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
  • Primary endpoint: Time to first breakthrough OHE episode, defined as a marked deterioration in neurological function and an increase in Conn score to grade ≥2 or an increase in Conn score and asterixis grade of 1 each if subject entered study at grade 0
  • Key secondary endpoint: HE-related hospitalization

XIFAXAN number needed to treat (NNT)2

XIFAXAN Number Needed to Treat (NNT) chart
XIFAXAN Number Needed to Treat (NNT) chart

†91% of patients in the XIFAXAN group were on concomitant lactulose.1

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Dr. Jesudian discuss some of the AASLD Guidelines for managing OHE

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Examples to help you identify patients in your practice at risk for OHE recurrence

Medical History

Medical history

  • History of cirrhosis
  • Has had several OHE episodes in recent months
  • Has been on lactulose but not currently taking any other medication for the reduction in risk of OHE recurrence

You should consider XIFAXAN as an add-on to lactulose for this patient.

Medical History

Medical history

  • Diagnosed with OHE after being hospitalized due to a moderate to severe OHE episode several months ago
  • Recently taken to the emergency department (ED) due to lethargy and reduced consciousness, later classified as a second OHE episode
  • Discharged from the ED without medications for the reduction in risk of OHE recurrence and with a note to follow up with her PCP

You should consider XIFAXAN as an add-on to lactulose for this patient.

Medical History

Medical history

  • Diagnosed with cirrhosis of the liver a few years ago; currently awaiting a transplant
  • Has had several moderate to severe OHE episodes in the past several months
  • Today, he has no symptoms associated with OHE and has been on and off lactulose therapy

You should consider prescribing XIFAXAN in addition to lactulose.

Medical History

Medical history

  • Currently on lactulose maintenance therapy after her second OHE episode in the past few months
  • Had an OHE recurrence while on lactulose therapy

You should consider XIFAXAN for this patient.

Medical History

Medical history

  • Diagnosed with OHE
  • Has experienced 2 OHE episodes over the past several months, both requiring hospitalization
  • Has been taking lactulose and is under the care of her hepatologist

You might consider XIFAXAN for this patient.

AASLD Guidelines Grade I,A,1 seal


Align with the guidelines by using the only FDA-approved agent indicated for the reduction in risk of OHE recurrence in adults1

XIFAXAN earned the highest possible recommendation (GRADE I,A,1) by the AASLD/EASL as an add-on therapy to lactulose to reduce the risk of OHE recurrence after a patient has a recurrence while on lactulose alone3,‡

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‡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.3

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XIFAXAN has a proven
safety profile

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AASLD, American Association for the Study of Liver Diseases; EASL, European Association for the Study of the Liver; HE, hepatic encephalopathy; OHE, overt hepatic encephalopathy; PCP, primary care physician.

References: 1. XIFAXAN. Prescribing information. Salix Pharmaceuticals; 2023. Accessed November 20, 2024. https://shared.salix.com/globalassets/pi/xifaxan550-pi.pdf 2. Bass NM, Mullen KD, Sanyal A, et al. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010;362(12):1071-1081. doi:10.1056/NEJMoa0907893 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. doi:10.1002/hep.27210

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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.0181.USA.23V4.0