XIFAXAN 550 mg is indicated to reduce the risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years of age and older. XIFAXAN 550 mg is a nonsystemic antibiotic treatment option providing efficacy and tolerability for control of overt HE recurrence.
Hepatic encephalopathy is a chronic complication of cirrhosis that causes a variety of mental and physical symptoms. It is marked by a cycle of remission followed by recurrence that is difficult to break.
XIFAXAN 550 mg can help reduce the risk of overt HE recurrence and may reduce HE-related hospitalizations over a 6-month period.1
For additional information on the reimbursement process or for reimbursement assistance for XIFAXAN 550 mg, please visit Xifaxan550helpline.com.
Visit Xifaxan550.com for additional resources for your practice, including
- H.E.L.P.–the HE Living Program
- The role of gut flora in HE
*HE = hepatic encephalopathy.
Indication for XIFAXAN 550 mg
XIFAXAN® (rifaximin) 550 mg tablets are indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥ 18 years of age.
Important Safety Information about XIFAXAN 550 mg
XIFAXAN® (rifaximin) 550 mg tablets are not for everyone. Do not take XIFAXAN if you have a known hypersensitivity to rifaximin or any of the components in XIFAXAN.
XIFAXAN, like nearly all antibiotics, can alter the normal bacteria of the colon. This can lead to an overgrowth of Clostridium difficile (C. difficile) bacteria. If you take XIFAXAN, there is a chance you could experience diarrhea caused by C. difficile. C. difficile can cause symptoms ranging in severity from mild diarrhea to fatal colitis. If you suspect you have C. difficile–associated diarrhea, contact your healthcare provider immediately, as treatment may need to be discontinued.
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 that are P-glycoprotein inhibitors (such as cyclosporine) as using these drugs with XIFAXAN may lead to 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.
In the clinical study, the most common side effects 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).
Xifaxan 550 mg is licensed by Alfa Wassermann S.p.A. to Salix Pharmaceuticals, Inc.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Reference: 1. XIFAXAN [prescribing information]. Raleigh, NC: Salix Pharmaceuticals, Inc; 2011.
The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.