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Investigating an IBS-D Therapy: Key Findings From Clinical Trial & Practice Settings

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Investigating an IBS-D Therapy: Key Findings From Clinical Trial & Practice Settings

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Once you know the key clinical trial data on a treatment option for IBS-D, how can you talk to your patients about this therapeutic approach?

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Indication and Important Safety Information below.

  • Overview

    XIFAXAN® (rifaximin) is an antibiotic for adult patients with IBS-D that has been investigated in multiple trials. But knowing the safety and efficacy data that led to its FDA approval is just as important as knowing how to talk to your patients about this treatment option. That’s why Drs Mark Pimental and Darren Brenner are here to break down the data on XIFAXAN. You’ll then hear from nurse practitioner Joscelyn Greaves and patient advocate Samantha, who’ll share insights into how you can talk to your patients about IBS-D and XIFAXAN.

  • Indication

    XIFAXAN® (rifaximin) 550 mg tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

  • Important Safety Information (ISI)

    • 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.
    • 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.
    • 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.
    • 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.
    • In clinical studies, the most common adverse reactions for XIFAXAN in IBS-D (≥2%) were nausea (3%) and ALT increased (2%).
    • INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
    • XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.

    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.

    The XIFAXAN 550 mg product and the XIFAXAN trademark are licensed by 
    Alfasigma S.p.A to Salix Pharmaceuticals or its affiliates.
    © 2023 Salix Pharmaceuticals or its affiliates. XIFI.0074.USA.23

Schedule25 Feb 2024