diagnosis

Watch the
TV Spot
Request
a Rep
Watch the TV Spot Request a Rep

The majority of IBS-D patients suffer with multiple symptoms1

Make a symptom-based diagnosis within your office2-4

Undiagnosed in

%
of patients5

Irritable bowel syndrome with diarrhea (IBS-D) affects approximately 4.8 million adults in the US.5-7 Diagnosis is based on clinical history, symptoms, physical examination, limited diagnostic testing, and exclusion of alarm features.2-4 In fact, the American College of Gastroenterology does not recommend routine diagnostic testing in patients when symptom-based criteria are fulfilled and alarm features are not present.8

WATCH

Dr. Pimentel discuss the diagnostic criteria for patients with IBS-D.

SEE MORE FROM YOUR PEERS

IBS-D can be diagnosed in adults based on symptoms alone2-4

Icon history

Evaluate patient history based on Rome IV criteria for IBS-D

  • Abdominal pain at least 1 day per week for the past 3 months* associated with 2 or more of the following: . Defecation . Change in stool frequency . Change in stool form . <25% hard lumpy stool, >25% loose watery stool

    *With symptom onset at least 6 months prior to diagnosis.2

Icon alarm

Exclude alarm features

  • Symptom onset after age 50
  • Severe or worsening symptoms
  • Weight loss
  • Nocturnal diarrhea
  • Rectal bleeding
  • Iron-deficiency anemia
  • Family history of colorectal cancer, celiac disease, IBD
Icon physical

Use physical exam and limited diagnostic testing

In diagnosed patients,

97.1%

were accurately diagnosed with IBS, using symptom-based criteria9,†

Population sample of 5931 adults using Rome IV Diagnostic Questionnaires.9

XIFAXAN Patient Brochure

Inform your patients with IBS-D about XIFAXAN

Download Download

WATCH

Dr. Moussa discuss diagnosing IBS-D and treating with XIFAXAN

SEE MORE FROM YOUR PEERS

Use the 25% Rule to determine IBS-D type2

On days with at least one abnormal bowel movement2

  • <25% of bowel movements with hard, lumpy stool (type 1 or 2 on the Bristol Stool Form Scale)
  • >25% of bowel movements with loose, watery stool (type 6 or 7 on the Bristol Stool Form Scale)
BSS chart

The Bristol Stool Form Scale has been shown to be a reliable surrogate marker for colonic transit. Copyright Rome Foundation, Bristol Stool Form Scale developed by Dr. Ken Heaton, University of Bristol, UK

Interpreting Rome IV for healthcare providers10

In 2021, the Rome Foundation proposed modified criteria for application of the Rome IV diagnostic criteria to the clinical practice setting. The intent was to allow clinicians to make a diagnosis and reduce unnecessary diagnostic testing. These criteria do not replace the standard Rome IV criteria for clinical trials or epidemiologic or pathophysiologic studies.

Nature of symptoms

The qualitative features of the Rome IV criteria must be met.

Bothersomeness

Patients should have sufficiently bothersome symptoms to seek care or affect daily activity.

Frequency

A frequency lower than the Rome IV threshold is permitted, provided that the symptoms are bothersome enough to interfere with daily activity or require treatment.

Bothersomeness

Patients should have sufficiently bothersome symptoms to seek care or affect daily activity.

Frequency

A frequency lower than the Rome IV threshold is permitted, provided that the symptoms are bothersome enough to interfere with daily activity or require treatment.

Duration

To provide some assurance that other diagnoses have been excluded, symptoms should be present for the previous 8 weeks. The Rome IV requirement of a 3-month duration* of symptoms is not required.

*With symptom onset at least 6 months prior to diagnosis.2

Exceptions are when a clinician needs to make an earlier diagnosis and is satisfied that the medical evaluation excludes other disease or for diagnoses where the symptoms occur infrequently and intermittently.10

IBS-D, irritable bowel syndrome with diarrhea.

References: 1. American Gastroenterological Association. IBS in America: survey summary findings. December 2015. Accessed January 4, 2024. http://www.multivu.com/players/English/7634451-aga-ibs-in-america-survey/docs/survey-findings-pdf-635473172.pdf 2. Lacy BE, Pimentel M, Brenner DM, et al. ACG clinical guideline: management of irritable bowel syndrome. Am J Gastroenterol. 2021;116(1):17-44. 3. Lacy BE, Patel NK. Rome criteria and a diagnostic approach to irritable bowel syndrome. J Clin Med. 2017;6(11):99. 4. Lembo A, Sultan S, Chang L, Heidelbaugh JJ, Smalley W, Verne GN. AGA Clinical Practice guideline on the pharmacological management of irritable bowel syndrome with diarrhea. Gastroenterology. 2022;163:137-151. 5. US Census Bureau. National demographic analysis tables: 2020. Updated March 10, 2022. Accessed January 8, 2024. https://www.census.gov/data/tables/2020/demo/popest/2020-demographic-analysis-tables.html 6. Palsson OS, Whitehead W, Törnblom H, Sperber AD, Simren M. Prevalence of Rome IV functional bowel disorders among adults in the United States, Canada, and the United Kingdom. Gastroenterology. 2020;158(5):1262-1273.e3. 7. Sperber AD, Bangdiwala SI, Drossman DA, et al. Worldwide prevalence and burden of functional gastrointestinal disorders, results of Rome Foundation Global Study. Gastroenterology. 2021;160(1):99-114.e3. doi:10.1053/j.gastro.2020.04.014 8. Ford AC, Moayyedi P, Lacy BE, et al; Task Force on the Management of Functional Bowel Disorders. American College of Gastroenterology monograph on the management of irritable bowel syndrome and chronic idiopathic constipation. Am J Gastroenterol. 2014;109(suppl 1):S2-S26. 9. Palsson OS, Whitehead WE, van Tilburg MAL, et al. Development and validation of the Rome IV diagnostic questionnaire for adults. Gastroenterology. 2016;150(6):1481-1491. 10. Drossman DA, Tack J. Rome Foundation clinical diagnostic criteria for disorders of gut-brain interaction. Gastroenterology. 2022;162(3):675-679. doi:10.1053/j.gastro.2021.11.019 11. Pimentel M, Lembo A, Chey WD, et al. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011;364(1):22-32. 12. Zhong W, Lu X, Shi H, et al. Distinct microbial populations exist in the mucosa-associated microbiota of diarrhea predominant irritable bowel syndrome and ulcerative colitis. J Clin Gastroenterol. 2019;53(9):660-672. 13. Sundin J, Aziz I, Nordlander S, et al. Evidence of altered mucosa-associated and fecal microbiota composition in patients with irritable bowel syndrome. Nature News. January 17, 2020. Accessed January 4, 2024. https://www.nature.com/articles/s41598-020-57468-y

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 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.
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.

XIFI.0144.USA.23V2.0