Change condition: IBS-D
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SAFETY
& DOSING

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In this section:

In adults with IBS-D

XIFAXAN has a well-established safety profile1

Side effects at rates similar to placebo

safety profile chart

safety profile chart
safety profile chart
TARGET 3 study design1

ALT, alanine aminotransferase; NA, not available.

*Most of the events of ALT increase were due to transient increases that resolved over time and were not temporally associated with study drug treatment.2

  • Constipation was observed in 0.3%-0.6% of patients treated with XIFAXAN2,3
  • Did not cause any clinically relevant antibiotic resistance after 1 to 3 treatment cycles4
  • 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 discontinued1

2 weeks of XIFAXAN delivered 
lasting relief of multiple symptoms1,2,5

Most treatments manage symptoms with continuous daily therapy, 
but XIFAXAN is different1,6,7

  • tablet icon

    One 550-mg tablet 3 times a day with or without food1

  • calendar icon

    2 weeks of treatment, not continuous, daily prescription medication1

  • physical

    Patients who complete initial treatment can be retreated up to 2 times for recurrence1

  • physical

    Provided relief of multiple IBS-D symptoms: abdominal pain, diarrhea, bloating, and urgency1,5,8,9

Patient brochure

XIFAXAN Dosing Flashcard

A summary of dosing information for prescribing XIFAXAN.

Download

ICD-10 code for IBS-D10,†

K58.0 Irritable bowel syndrome with diarrhea

Rx

XIFAXAN 550 mg

3 times a day for 14 days

#42 tablets

Can retreat up to 2 times

Patient brochure

XIFAXAN Dosing Flashcard

A summary of dosing information for prescribing XIFAXAN.

Download

WATCH

Dr. Pimentel discuss XIFAXAN dosing

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IBS-D, irritable bowel syndrome with diarrhea.

†The ICD-10 codes and all other patient-access–related information are provided for informational purposes only. It is the treating physician’s responsibility to determine the proper diagnosis, treatment, and applicable ICD-10 code. Salix Pharmaceuticals does not guarantee coverage or reimbursement for the product.

References: 1. XIFAXAN. Prescribing information. Salix Pharmaceuticals; 2023. Accessed January 3, 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. 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. 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. 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 January 4, 2024. https://pdf.hres.ca/dpd_pm/00041275.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 December 1, 2021. Accessed January 4, 2024. www.cms.gov/Medicare/Coding/ICD10

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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.

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