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| {{customText[Hello|Hi|Dear]}} {{customText[Dr|Mr|Mrs|Ms]}}. {{accLname}}, |
| You already know that XIFAXAN is the only FDA-approved agent indicated for the reduction in risk of OHE recurrence in adults.1 A new commercial is introducing it to patients and caregivers, and they may be coming to you for more information. |
| If you or your staff have any additional questions or needs after reading the information below, please don’t hesitate to contact me, {{userName}}. |
| OHE, overt hepatic encephalopathy. |
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| SELECT 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. |
| Please see additional Important Safety Information below. |
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| Remember—XIFAXAN was given the highest possible recommendation by AASLD/EASL as an add-on therapy to lactulose to reduce the risk of OHE recurrence after a patient has a recurrence while on lactulose alone2,* |
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| AASLD, American Association for the Study of Liver Diseases; EASL, European Association for the Study of the Liver. |
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Per the GRADE System for Evidence: Grade I=randomized, controlled trials; A=evidence is “high quality,” and further research is very unlikely to change our confidence in the estimated effect; and 1=recommendation is “strong,” with factors influencing strength of recommendation including the quality of evidence, presumed patient-important outcomes, and costs.2 |
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| INDICATION |
| XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults. |
| IMPORTANT SAFETY INFORMATION |
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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. |
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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. |
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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. |
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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. |
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In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with
lactulose) were:
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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%) |
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INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required. |
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XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus. |
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| 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. |
| If you have any questions or want to discuss anything further, I would be happy to chat. Reach out to me at {{User.Phone}}. |
| Very best, |
| {{userName}} |
| {{userPhoto}} |
| References: 1. XIFAXAN. Prescribing information. Salix Pharmaceuticals; 2022. Accessed March 14, 2023. https://shared.salix.com/globalassets/pi/xifaxan550-pi.pdf 2. Vilstrup H, Amodio P, Bajaj J, et al. Hepatic encephalopathy in chronic liver disease: 2014 practice guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014;60(2):715‑735. |
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