back Back to Video Library

Efficacy of XIFAXAN for overt hepatic encephalopathy

Dr. Fred Poordad

Professor at University of Texas Health Science Center San Antonio (UTHSCSA) in San Antonio, Texas

Watch Dr. Poordad describe the Phase 3 clinical trial that assessed the efficacy of XIFAXAN in reducing the risk of recurrence for overt HE and HE-related hospitalizations.

  • 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
  • Primary endpoint: Time to first breakthrough overt HE episode, defined as a marked deterioration in neurological function (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
  • 91% of patients in the placebo and XIFAXAN groups were on lactulose1
  • Select Important Safety Information
    In a clinical study, the most common adverse reactions for XIFAXAN in HE (≥10%) were peripheral edema (15%), nausea (14%), dizziness (13%), fatigue (12%), and ascites (11%).

    Please see additional Important Safety Information below.

Related videos

Hepatic encephalopathy is a problem hiding in plain sight video thumbnail

Hepatic encephalopathy is a problem hiding in plain sight
Screening cirrhosis patients early for HE, before hospitalization video thumbnail

Recognizing patients at risk for hepatic encephalopathy
Screening cirrhosis patients early for HE, before hospitalization video thumbnail

Screening cirrhosis patients early for HE, before hospitalization
Watch the
TV Spot Connect With Us
Watch the TV Spot Connect With Us

HE, hepatic encephalopathy.

References: 1. XIFAXAN [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals. 2. Bass NM, Mullen KD, Sanyal A, et al. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010;362(12):1071-1081.

See More

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.
See Less

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.0190.USA.23V2.0