About XIFAXAN

What is XIFAXAN (zī-fax-an)?

XIFAXAN is a 2-week prescription treatment that provided lasting relief from abdominal pain and diarrhea in clinical trials.*

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2 week prescription treatment*

Intestine

FDA approved for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults

#1 doctor

#1 doctor-prescribed medication approved for IBS-D

Recommendation

Recommended by the American College of Gastroenterology

*In clinical trials, more patients taking XIFAXAN vs placebo for 2 weeks had relief of IBS-D symptoms for the month following treatment. Median time of symptom relief was 10 weeks (range of 6 to 24 weeks). You can be treated again up to 2 times if symptoms come back. Individual results may vary.

Based on aggregated total of all prescribers as of June 2022.

The American College of Gastroenterology has given Xifaxan (rifaximin) a strong recommendation to treat global IBS-D symptoms. This is based on moderate clinical information.

Gut bacteria

XIFAXAN works by slowing the growth of some bacteria in your gut.

The exact cause of IBS-D is unknown; however, it is believed that an imbalance in gut bacteria may be linked to IBS-D symptoms.

Talk to your doctor before taking XIFAXAN if you have severe hepatic (liver) impairment, as this may cause increased effects of the medicine.

Results with XIFAXAN

2 weeks of XIFAXAN provided relief from both abdominal pain and diarrhea compared to placebo*

Relief from abdominal pain and diarrhea

%
XIFAXAN

(n=291/624)

%
Placebo

(n=237/634)

Relief from abdominal pain

%
XIFAXAN

(n=324/624)

%
Placebo

(n=270/634)

Relief from diarrhea

%
XIFAXAN

(n=477/624)

%
Placebo

(n=418/634)

  • XIFAXAN
  • Placebo

In a pooled analysis of TARGET 1 and 2 clinical trials. Efficacy responder rates in TARGET trials 1 and 2 during the month following 2 weeks of treatment. No rescue medication was allowed in these clinical trials.

*You can be re-treated up to 2 times if symptoms return. Individual results may vary.

Composite endpoint.

TARGET 1 and 2 study design: Two identical phase 3, randomized, double-blind, placebo-controlled trials were conducted over a 3-month period. A total of 1258 patients meeting Rome II criteria for IBS-D were to receive XIFAXAN 550 mg 3 times a day (n=624) or placebo (n=634) for 14 days.

Primary endpoint: Adequate relief of IBS-D signs and symptoms for at least 2 of 4 weeks during the month following 14 days of treatment, with adequate relief defined as a response of “yes” to the weekly Subject Global Assessment (SGA) question: “In regards to your IBS-D symptoms, compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS-D symptoms? [Yes/No].”

Primary endpoint results: 41% of patients (254 of 624) in the XIFAXAN 550-mg group, 31% of TARGET 1 trial placebo group (98 of 314), and 32% of TARGET 2 trial placebo group (103 of 320) experienced adequate relief of IBS-D signs and symptoms.

Secondary endpoint: In both studies, more patients in the XIFAXAN 550-mg group had adequate relief of global IBS-D symptoms (see primary endpoint for definition) within the first month compared with the placebo group. Relief continued during the first 2 months and throughout all 3 months in both studies.

Composite endpoint: ≥30% decrease from baseline in abdominal pain, with a weekly mean stool consistency score of <4 (loose stool) for ≥2 weeks during the month following 2 weeks of treatment.

In adults with IBS-D, XIFAXAN provided relief from bloating and urgency

Relief from bloating

Percentage of bloating responders based on weekly responses in a pooled analysis of TARGET 1 and 2 trials.

%
XIFAXAN

(n=251/624)

%
Placebo

(n=192/634)

Key secondary endpoint: The proportion of subjects who achieved adequate relief of IBS-D–related bloating (ie, responders) for at least 2 of 4 weeks during the month following 14 days of treatment. A bloating responder was defined as a patient who responded “yes” to the weekly questions: “In regards to your IBS-D symptom of bloating, compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS-D symptom of bloating? [Yes/No].”

Responses were given during the first 4 weeks of the treatment-free period following 2 weeks of active treatment (primary evaluation period).

Relief from urgency

Percentage of urgency responders based on weekly responses in TARGET 1, 2, and 3 trials in a pooled post hoc analysis.

%
XIFAXAN

(n=323/609)

%
Placebo

(n=264/618)

Secondary endpoint: Change from baseline to each week during the 12-week study duration for sense of urgency. An urgency responder was defined as a patient with a ≥30% decrease from baseline in the percentage of days with urgency for at least 2 of 4 weeks during the month following 14 days of treatment. Urgency was determined based on a patient response of “yes” to the daily question: “Have you felt or experienced a sense of urgency today? [Yes/No].”

Stool frequency (number of bowel movements per day) was assessed as a secondary endpoint, but there was no meaningful difference between XIFAXAN and placebo.

  • XIFAXAN
  • Placebo

XIFAXAN Re-Treatment Study Emphasizes Effectiveness and Safety for Re-Treated Patients

Re-treatment graphics Re-treatment graphics

§36% of open-label responders did not experience relapse during the 18-week observation phase before being withdrawn from the trial for any reason.

TARGET 3 study design: This trial included an open-label phase followed by a randomized, placebo-controlled phase, with the aim of determining the efficacy and safety of repeat treatment with XIFAXAN in patients with IBS-D who had responded to a 2-week course of XIFAXAN and subsequently experienced IBS-D symptom recurrence.

A responder was defined as a patient experiencing a ≥30% improvement from baseline in the weekly average abdominal pain score (based on daily self-reports) and a ≥50% reduction in the number of days in a week with a daily stool consistency of Bristol Stool Form Scale type 6 or 7 (mushy or watery) for ≥2 of the 4 weeks after treatment.

Recurrence was defined as the return of abdominal pain or lack of stool consistency for 3 weeks of a rolling 4-week period.

Primary endpoint: The proportion of patients who were responders to repeat treatment in both IBS-D–related abdominal pain and stool consistency during the 4 weeks following the first repeat treatment course.

Taking XIFAXAN

XIFAXAN is a short-term treatment that you take 3 times a day for 2 weeks.

Doctor icon

Follow your doctor’s instructions exactly when taking XIFAXAN

Pill icon

XIFAXAN comes in a tablet form that can be taken by mouth

Food icon

XIFAXAN tablets can be taken with or without food

Two icon

You can be treated again up to 2 times if symptoms come back

Side effects with XIFAXAN treatment

In clinical studies, the most common side effects with XIFAXAN for IBS-D were:

  • Nausea (feeling sick to your stomach)*
  • An increase in liver enzymes

Constipation was observed in 0.3%-0.6% of patients treated with XIFAXAN.

*Nausea was observed in 3% of patients taking XIFAXAN vs 2% taking placebo.

Liver enzymes increase observed in 2% of patients taking XIFAXAN vs 1% taking placebo.

Other important considerations

  • NOT a controlled substance
  • NOT contraindicated for patients without a gallbladder
  • NO association of pancreatitis was observed in patients taking XIFAXAN in the clinical trials

XIFAXAN is an antibacterial medication, or antibiotic, that did not cause any clinically relevant antibiotic resistance after 1 to 3 treatment cycles. If you take antibiotics, like XIFAXAN, there is a chance you could experience diarrhea caused by an overgrowth of bacteria (C. difficile). This can cause symptoms ranging in severity from mild diarrhea to life-threatening colitis. Contact your doctor if your diarrhea does not improve or worsens.

ACG badge

The American College of Gastroenterology (ACG), a leading authority in GI disorders, has given XIFAXAN (rifaximin) a strong recommendation to treat global IBS-D symptoms. This is based on a moderate level of clinical trial data.

If you want to learn more about the clinical data supporting the recommendation to see if XIFAXAN is right for you, talk to your doctor.

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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 not for everyone. Do not take XIFAXAN if you have a known hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN.
  • If you take antibiotics, like XIFAXAN, there is a chance you could experience diarrhea caused by an overgrowth of bacteria (C. difficile). This can cause symptoms ranging in severity from mild diarrhea to life-threatening colitis. Contact your healthcare provider if your diarrhea does not improve or worsens.
  • XIFAXAN is not for everyone. Do not take XIFAXAN if you have a known hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN.
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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 not for everyone. Do not take XIFAXAN if you have a known hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN.
  • If you take antibiotics, like XIFAXAN, there is a chance you could experience diarrhea caused by an overgrowth of bacteria (C. difficile). This can cause symptoms ranging in severity from mild diarrhea to life-threatening colitis. Contact your healthcare provider if your diarrhea does not improve or worsens.
  • Talk to your healthcare provider before taking XIFAXAN if you have severe hepatic (liver) impairment, as this may cause increased effects of the medicine.
  • Tell your healthcare provider if you are taking drugs called P-glycoprotein and/or OATPs inhibitors (such as cyclosporine) because using these drugs with XIFAXAN may lead to an increase in the amount of XIFAXAN absorbed by your body.
  • In clinical studies, the most common side effects for XIFAXAN were:
    • - HE: Peripheral edema (swelling, usually in the ankles or lower limbs), constipation, nausea (feeling sick to your stomach), fatigue (feeling tired), insomnia (trouble sleeping), ascites (a buildup of fluid in the abdomen), dizziness, urinary tract infection, anemia (low red blood cell levels), and itching
    • - IBS-D: Nausea (feeling sick to your stomach) and an increase in liver enzymes
  • XIFAXAN may affect warfarin activity when taken together. Tell your healthcare provider if you are taking warfarin because the dose of warfarin may need to be adjusted to maintain proper blood-thinning effect.
  • If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking XIFAXAN because XIFAXAN may cause harm to an unborn baby or nursing infant.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-321-4576
Fax: 1-510-595-8183
Salix Product Information Call Center
Phone: 1-800-321-4576
Fax: 1-510-595-8183

Please click here for full Prescribing Information. RX only.

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