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XIFAXAN is believed to affect an underlying factor of IBS-D

by directly attacking bacteria in the gut that may be linked to IBS-D symptoms1-6

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Blocks one of the steps in the transcription of bacterial DNA to RNA1

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Inhibits bacterial
protein synthesis1

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Inhibits bacterial growth1

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See how XIFAXAN is believed to work

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Mechanism of action is unknown and does not imply clinical efficacy

XIFAXAN is the only FDA-approved, nonsystemic IBS-D treatment that alters the microbiome1,3

Less than 0.4% is absorbed from the GI tract

There is an increased systemic exposure in patients with severe hepatic impairment (Child-Pugh Class C). Caution should be exercised when administering XIFAXAN to these patients.

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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XIFAXAN has a well-established safety profile1

COMPARE TO PLACEBO

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Healthcare professionals discuss different approaches used to manage IBS-D symptoms

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Make a symptom-based
diagnosis of IBS-D
with confidence7-9

FIND ROME IV CRITERIA

Bacterial imbalance, or gut dysbiosis, has been linked to symptoms of IBS-D2,10,11

GET THE FACTS

CDAD, Clostridium difficile-associated diarrhea; FDA, US Food and Drug Administration; GI, gastrointestinal.

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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 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.
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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.

References: 1. XIFAXAN. Prescribing information. Salix Pharmaceuticals; 2023. Accessed November 27, 2024. https://shared.salix.com/globalassets/pi/xifaxan550-pi.pdf 2. Lembo A, Pimentel M, Rao SS, et al. Repeat treatment with rifaximin is safe and effective in patients with diarrhea-predominant irritable bowel syndrome. Gastroenterology. 2016;151(6):1113-1121. doi:10.1053/j.gastro.2016.08.003 3. Schoenfeld P, Pimentel M, Chang L, et al. Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double-blind, placebo-controlled trials. Aliment Pharmacol Ther. 2014;39(10):1161-1168. doi:10.1111/apt.12735 4. Pimentel M, Cash BD, Lembo A, Wolf RA, Israel RJ, Schoenfeld P. Repeat rifaximin for irritable bowel syndrome: no clinically significant changes in stool microbial antibiotic sensitivity. Dig Dis Sci. 2017;62(9):2455-2463. doi:10.1007/s10620-017-4598-7 5. Pimentel M, Lembo A, Chey WD, et al; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011;364(1):22-32. doi:10.1056/NEJMoa1004409 6. Viberzi. Prescribing information. Allergan; 2020. Accessed January 4, 2024. https://www.rxabbvie.com/pdf/viberzi_pi.pdf 7. Amitriptyline HCl. Prescribing information. Sandoz; 2020. Accessed November 27, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085966s095,085969s084,085968s096,085971s075,085967s076,085970s072lbl.pdf 8. Schoenfeld PS, Brenner DM, Pichetshote N, Heimanson Z, Lacy BE. Rifaximin significantly improves bowel movement urgency in patients with irritable bowel syndrome with diarrhea: a pooled analysis of three phase 3 trials. Poster presented at: Digestive Disease Week; May 21-23, 2021; virtual. 9. Pimentel M, Cash BD, Lacy BE, Heimanson Z, Lembo A. Assessing the efficacy of rifaximin in diarrhea-predominant irritable bowel syndrome: a post hoc analysis of two phase 3, randomized, placebo-controlled trials. Poster presented at: World Congress of Gastroenterology; October 13-18, 2017; Orlando, FL. 10. ICD-10. Centers for Medicare & Medicaid Services. Updated September 26, 2024. Accessed November 27, 2024. www.cms.gov/Medicare/Coding/ICD10

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