Support for you and appropriate patients with HE

The resources below include information that may help when prescribing XIFAXAN, insurance requirements, and videos about HE. You'll also find materials to share with appropriate patients with HE, including the H.E.L.P. Support Guide. These resources may help you get appropriate patients on XIFAXAN, and help them reach your goals for their treatment.

AASLD/EASL 2014 Guideline Overview

Quickly review the recommended options for adult patients with overt HE.

Considerations for PAs Handout

Provides directions for submitting a PA for XIFAXAN when needed.

Letter of Medical Necessity

A standard form for a patient‐specific letter of medical necessity to explain your clinical decision-making in choosing a therapy.

Tier Exception Request

A Tier Exception request to reduce the cost-share of a medication. Follows submission of a PA or Utilization Management request.

HE = hepatic encephalopathy.

H.E.L.P. = Hepatic Encephalopathy Living Program.

AASLD = American Association for the Study of Liver Diseases.

EASL = European Association for the Study of the Liver.

PA = Prior Authorization.

Wrestling the Monster

Study the face of HE in 4 patients and their caregivers as they describe the toll HE takes on them and their families.

HE = hepatic encephalopathy.

H.E.L.P. Support Guide

A guide to help patients and caregivers find answers and details about living with HE.

HE Symptom Checklist

A handy tool to help patients and caregivers recognize the mental and physical symptoms of HE.

HE Hospital Discharge Guide

Information about HE that hospitalized patients should know before and after discharge from the hospital.

Low-income Subsidy Brochure

Learn about Extra Help/LIS program benefits. Identify the two ways patients can receive Extra Help/LIS benefits. Discover how you can help patients apply for Extra Help/LIS benefits.

Instant Savings Card

Available for eligible,* commercially insured patients.

H.E.L.P. = Hepatic Encephalopathy Living Program.

HE = hepatic encephalopathy.

LIS = Low-income subsidy.

*Patient is not eligible if he/she participates in or seeks reimbursement or submits a claim for reimbursement to any federal or state healthcare program with prescription drug coverage, such as Medicaid, Medicare, Medigap, VA, DOD, TRICARE, or any similar federal or state health care program (each a Government Program), or where prohibited by law. Patient must be enrolled in, and must seek reimbursement from or submit a claim for reimbursement to, a commercial insurance plan. Offer excludes full cash-paying patients. Maximum benefits and other restrictions apply. Visit https://xifaxan.copaysavingsprogram.com/ or call 1-866-XIFAXAN for full eligibility criteria, terms and conditions.

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 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 were:
    • HE (≥10%): Peripheral edema (15%), nausea (14%), dizziness (13%), fatigue (12%), and ascites (11%)
    • IBS-D (≥2%): Nausea (3%), 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.

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 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.