Rifaximin (Xifaxan)

ORAL ADMINISTRATION

Indications for Prior Authorization:

  • Treatment of patients at least 12 years of age with traveler's diarrhea caused by noninvasive strains of Escherichia coli
  • Reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients at least 18 years of age
  • Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults

Patients must meet the following criteria for the indication(s) above:

  • Traveler's diarrhea
    • Patient is 18 years of age or older with traveler's diarrhea, AND failure or clinically significant adverse effects to ciprofloxacin OR
    • Patient is 12-17 years of age with traveler's diarrhea
  • Hepatic Encephalopathy
    • Treatment or prophylaxis of hepatic encephalopathy, AND failure or clinically significant adverse effects to lactulose
  • Small Intestinal Bacterial Overgrowth (SIBO)
    • Patient has SIBO, AND failure or clinically significant adverse effect to ciprofloxacin AND amoxicillin/clavulanate
  • Crohn's Disease
    • Patient has Crohn's Disease, AND failure or clinically significant adverse reaction to metronidazole OR ciprofloxacin
  • Irritable Bowel Syndrome with Diarrhea (IBS-D)
    • Patient has IBS-D, AND failure of or clinically significant adverse effects to TWO of the following:
      • Bulk forming agent (e.g., psyllium)
      • Anti-diarrhea agent (e.g., bismuth subsalicylate, loperamide)
      • Antispasmodic agent (e.g., diphenoxylate-atropine, dicyclomine, hyocyamine, hyoscyamine/atropine/scopolamine/phenobarbital)

The following conditions do not meet the criteria for use as established by WHA P&T committee:

  • Any condition not listed above in the indications section (examples below)
    • C. difficile infection
    • Diverticulitis and inflammatory bowel disease

Dosing:

  • Traveler's Diarrhea
    • Adults and children at least 12 years of age: 200 mg orally three times daily for 3 days (authorization limit 9 tablets/month)
  • Hepatic Encephalopathy
    • 550 mg orally twice daily
  • SIBO
    • 200 mg orally three times daily for 7 days OR
    • 550 mg orally twice daily for 14 days
  • IBS with SIBO
    • 550 mg orally three times daily for 7 days
  • Crohn's disease
    • 200 mg orally three times daily (authorization limit 12 weeks) OR
    • 800 mg orally twice daily (authorization limit 12 weeks)
  • IBS-D
    • 550 mg orally three times daily (authorization limit 550 mg orally three times daily for 14 days; patients who experience recurrence can be retreated up to two times with the same regimen)

Approval:

  • Hepatic Encephalopathy: 1 year
  • IBS-D
    • Initial: 1 treatment
    • Recurrence: 2 treatments
  • Crohn's disease: 3 months
  • All other approved indications: 1 treatment

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