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ABOUT HE

What is hepatic encephalopathy (HE) ?

HE is a possible consequence of liver disease.

Liver disease happens to many people for lots of different reasons. In fact,
approximately 30 million people in the United States have some form of liver disease.

Some of the common types of liver disease and their causes include:

Hepatitis A, B, and C,

which are 3 different strains of the hepatitis virus that can damage the liver.


Non-alcoholic fatty liver disease (NAFLD),

which is caused by too much fat in the liver cells. 


Alcohol-related liver disease,

which is the result of drinking too much alcohol.

All of these types of liver disease can damage and scar the liver.

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Liver disease can lead to other, more serious problems, such as cirrhosis.

Having liver disease over a long period of time may damage the liver and eventually lead to its soft, healthy tissue being replaced by hard scar tissue. This condition is called cirrhosis.

As cirrhosis becomes worse, the liver will have less and less healthy tissue. The liver is important because it filters everything that you eat and drink. It processes food into energy and nutrients that your body can use. It also gets rid of harmful substances called toxins.

Cirrhosis can cause symptoms and complications over time.

Cirrhosis may not cause any symptoms or complications at first, but over time it can lead to many. One serious complication of cirrhosis is hepatic encephalopathy, or HE.

HE may happen when a liver that has been damaged by cirrhosis cannot filter toxins out of the blood. These toxins can then build up in the brain and cause a range of different mental and physical symptoms.

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INDICATION

XIFAXAN® (rifaximin) 550 mg tablets are indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.

IMPORTANT SAFETY INFORMATION - XIFAXAN (rifaximin) 550 mg tablets in HE

  • 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 has not been studied in people with MELD scores over 25 and only 8.6% of people in the controlled study had MELD scores over 19. There is an increased chance that XIFAXAN will spread through your body if you have more severe hepatic dysfunction. Therefore, if you have severe hepatic impairment, which is a Child-Pugh score of C, you should talk to your healthcare provider before taking XIFAXAN.
  • Tell your doctor if you are taking drugs called P-glycoprotein inhibitors (such as cyclosporine) because using these drugs with XIFAXAN may lead to an increase in the amount of XIFAXAN absorbed by your body.
  • If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking XIFAXAN because it is unknown if XIFAXAN can harm an unborn baby or nursing infant.
  • In the clinical study, the most common side effects in HE associated with XIFAXAN 550 mg tablets—occurring in at least 10% of people receiving XIFAXAN—were peripheral edema (swelling, usually in the ankles or lower limbs), nausea (feeling sick to your stomach), dizziness, fatigue (feeling tired), and ascites (a buildup of fluid in the abdomen).

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: 1-800-508-0024
Fax: 1-510-595-8183
Email: valeantmc@dlss.com

Please click here for full Prescribing Information for XIFAXAN.

See MoreImportant Safety Information
See LessImportant Safety Information

INDICATION

XIFAXAN® (rifaximin) 550 mg tablets are indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.

IMPORTANT SAFETY INFORMATION - XIFAXAN (rifaximin) 550 mg tablets in HE

  • 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 has not been studied in people with MELD scores over 25 and only 8.6% of people in the controlled study had MELD scores over 19. There is an increased chance that XIFAXAN will spread through your body if you have more severe hepatic dysfunction. Therefore, if you have severe hepatic impairment, which is a Child-Pugh score of C, you should talk to your healthcare provider before taking XIFAXAN.
  • Tell your doctor if you are taking drugs called P-glycoprotein inhibitors (such as cyclosporine) because using these drugs with XIFAXAN may lead to an increase in the amount of XIFAXAN absorbed by your body.
  • If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking XIFAXAN because it is unknown if XIFAXAN can harm an unborn baby or nursing infant
  • In the clinical study, the most common side effects in HE associated with XIFAXAN 550 mg tablets—occurring in at least 10% of people receiving XIFAXAN—were peripheral edema (swelling, usually in the ankles or lower limbs), nausea (feeling sick to your stomach), dizziness, fatigue (feeling tired), and ascites (a buildup of fluid in the abdomen).

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: 1-800-508-0024
Fax: 1-510-595-8183
Email: valeantmc@dlss.com

Please click here for full Prescribing Information for XIFAXAN.