About XIFAXAN

What is XIFAXAN (zī-fax-an)?

XIFAXAN is the only FDA-approved medicine that reduces the risk of overt HE (hepatic encephalopathy) recurrence in adults. In addition, it helps reduce the risk of HE-related hospitalizations. XIFAXAN is a medicine that can be part of your doctor's plan to help manage overt HE.

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

XIFAXAN is an antibiotic that does not affect the entire body but slows bacteria growth in the gut. These bacteria are believed to be linked to symptoms of overt HE.

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

XIFAXAN OHE Living Kit Flashcard

Download this brief guide to managing overt HE with XIFAXAN, including dosing and savings program details.

“XIFAXAN helped reduce my risk of further OHE episodes and HE-related hospitalizations.”

— Mark, a real XIFAXAN patient.

Results with XIFAXAN

XIFAXAN reduced 2 risks associated with overt HE

In a clinical study of 299 adults with a history of overt HE, patients took either one XIFAXAN 550 mg tablet 2 times a day (n=140) or placebo 2 times a day (n=159) for 6 months. 91% of patients took lactulose at the same time. The results were:

brain

Reduced risk of another
overt HE episode by

%

compared with placebo

XIFAXAN group: 22% of patients reported breakthrough HE episodes

Placebo group: 46% of patients reported breakthrough HE episodes

brain

Reduced risk of another
HE-related hospitalization by

%

compared with placebo

XIFAXAN group: 14% of patients had a hospitalization involving HE

Placebo group: 23% of patients had a hospitalization involving HE

Common side effects of XIFAXAN

In the same clinical study, the most common side effects reported by patients taking XIFAXAN (occurring in at least 10% of them and at a higher rate than in patients taking placebo) were:

  • 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)
  • Itching

These are not all of the side effects of XIFAXAN. Please see additional Important Safety Information below and click here for full Prescribing Information.

The safety and efficacy of XIFAXAN in adults with overt HE has not been studied for longer than 24 months in clinical trials. If patients recover a significant amount of liver function, they may be able to discontinue overt HE therapy only if instructed by their doctor.

common side effect

Taking XIFAXAN

  • X2

    XIFAXAN for overt HE comes as a 550 mg tablet that is taken 2 times a day, as recommended by a doctor

  • with without food

    XIFAXAN tablets can be taken with or without food

  • RX

    XIFAXAN should be taken as long as a doctor recommends

XIFAXAN is part of guideline-based care

Overt HE can be managed using guideline-based care

Your doctor may put you on guideline-recommended therapy that can include more than one medicine. These medicines help reduce the risk of additional overt HE episodes. Some of the most commonly used medicines are lactulose and XIFAXAN.

Guidelines recommend adding XIFAXAN

Expert guidelines recommend using both lactulose and XIFAXAN together to help reduce the risk of overt HE recurrence.

What is lactulose?

Lactulose is an artificial sugar. It comes as a very sweet liquid that is taken by mouth. It can also be given as an enema for people who cannot swallow.

Lactulose works by helping to cause more bowel movements. This helps to flush out toxins that may travel through your blood to your brain.

An adult with overt HE will work with his/her doctor to find the right amount of lactulose to take each day so that he/she can have 2-3 bowel movements each day.

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OHE, overt hepatic encephalopathy.

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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 reduction in risk of overt hepatic encephalopathy (HE) recurrence 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.

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.

XIF.0211.USA.23