RIFAXIMIN TAB
Clinical Criteria Summary
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Exclusion Criteria
- Known hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any other component of rifaximin
- Inclusion Criteria (Patient must meet one of the following sets; both endpoints in each set must be documented in the medical record)
- Refractory to lactulose: Recurrent or persistent hepatic encephalopathy despite receiving lactulose at a dose that obtains 2–3 loose stools per day
- Intolerance to lactulose: Treated with lactulose for recurrent or persistent hepatic encephalopathy and experiencing ≥4 loose stools per day despite lactulose dosage reductions
- Non-adherence to lactulose: Recurrent or persistent hepatic encephalopathy secondary to non-adherence of lactulose despite provision of patient education on more than one visit regarding the importance of adherence
Dosage and Administration
- 550mg orally twice daily, with or without food
- Each prescription limited to no more than a 3-month supply
Monitoring and Clinical Considerations
- May be used in combination with lactulose for hepatic encephalopathy
- Reassess medical treatment every 3 months after evaluating initial response and tolerability
- Monitor clinical signs and symptoms of hepatic encephalopathy, nutrition status, hydration status, and electrolytes
- Titrate lactulose dose to maintain two to three bowel movements per day; avoid overuse due to risks of aspiration, dehydration, hypernatremia, severe perianal skin irritation, and precipitation of hepatic encephalopathy
- Use with caution in patients with severe hepatic impairment (Child-Pugh C) due to increased systemic exposure; no dosage adjustment is recommended as rifaximin presumably acts locally
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Indication & Patient Population
- IBS-D (with or without SIBO)
- FDA-approved for treatment of IBS-D in adults; not FDA-approved for treatment of SIBO
- Restricted to patients with the IBS-D subtype who have not responded to effective and less costly symptom-based alternative therapies
Exclusion Criteria
- Known hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any other component of rifaximin
- No documented benefit from prior rifaximin therapy for irritable bowel syndrome with diarrhea (IBS-D)
Inclusion Criteria (All must be met)
- Patient is under the care of a VA or VA Community Care gastroenterologist or locally designated provider qualified to diagnose and treat both symptomatic small intestinal bacterial overgrowth (SIBO) and IBS-D
- Moderate to severe IBS-D (with or without SIBO)
- Moderate to severe symptoms (e.g., pain, bloating) continue or recur despite treatment
Prior Therapy Requirements
- Trial of soluble fiber (e.g., psyllium) for 4 weeks unless medically inadvisable or not tolerated
- Trial of a tricyclic antidepressant (e.g., desipramine, nortriptyline) for 4 weeks unless medically inadvisable (e.g., elderly, suicidal ideation, QT prolongation, etc.) or not tolerated
- For females with severe, chronic IBS-D (generally ≥ 6 months): Trial of alosetron for 4 weeks unless medically inadvisable or not tolerated
Dosage & Administration
- Approved dose for IBS-D: 550 mg 3 times a day for 14 days
Dispensing Limits
- Authorize one course of rifaximin with a maximum dispensing limit of three 200-mg or 550-mg tablets per day for up to 14 days
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Patient & Provider Eligibility
- Patient must be under the care of a VA or VA Community Care gastroenterologist or locally designated provider qualified to diagnose and treat symptomatic SIBO.
Diagnosis & Clinical Presentation
- Documented diagnosis or working diagnosis of SIBO without irritable bowel syndrome with diarrhea (IBS-D).
- Diagnosis based on typical clinical presentation and, if testing is feasible, positive carbohydrate breath test or jejunal aspirate culture.
Prior Therapy & Treatment History
- Documented lack of benefit from prior metronidazole or other antibiotic therapy for SIBO.
- Documented benefit from prior rifaximin for SIBO.
- ≥ 4 distinct and well-documented SIBO episodes in one year.
- Presence of risk factors for recurrent SIBO (e.g., small intestinal strictures [Crohn’s disease, radiation, surgery]; surgically created blind loops [end-to-side anastomosis]).
Dosing & Administration
- Prescription must be written for periodic administration (e.g., 5–10 days out of every month or every other week).
- For SIBO without IBS-D: 200 mg 3 times a day for 7 days to 550 mg 3 times a day for 10 days.
- Clinical study doses range from 200 to 550 mg 3 times a day, with durations often 7 to 10 days (range 5 to 28 days). Optimal dosage regimen has not been determined.
Dispensing & Retreatment Policies
- Maximum dispensing limit of three 200-mg or 550-mg tablets per day for up to 14 days.
- Additional retreatments (renewals or refills) do not require re-evaluation of the patient if an initial course was previously approved.
Exclusion Criteria
- Known hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any other component of rifaximin.
- No documented benefit from prior rifaximin therapy for SIBO.
- Reoccurrences of SIBO after durable response (≥ 3 months) to one antibiotic regimen for SIBO (these should be retreated rather than proceed to rifaximin).
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Patient Eligibility & Provider Qualifications
- Patient must be under the care of a VA or VA Community Care gastroenterologist or locally designated provider qualified to diagnose and treat symptomatic SIBO.
Diagnostic Criteria
- Documented diagnosis or working diagnosis of SIBO without irritable bowel syndrome with diarrhea (IBS-D).
- Diagnosis based on typical clinical presentation and, if testing is feasible, positive carbohydrate breath test or jejunal aspirate culture.
Prior Therapy Requirements (Additional Inclusion Criteria)
- Symptoms must not respond to a 7- to 10-day therapeutic trial of ONE of the following regimens (unless medically inadvisable or patient has history of intolerance):
- Metronidazole alone (250–500 mg 2–3 times a day; maximum two courses in a 6-month period)
- Metronidazole combined with cephalexin (500 mg 3–4 times a day) or sulfamethoxazole/trimethoprim double-strength (1 tab 2 times a day)
- Amoxicillin-clavulanate (500 mg 3 times a day or 875 mg 2 times a day)
- Neomycin (500 mg 2 times a day)
- Previous ciprofloxacin (250–500 mg twice a day) for SIBO (may count as required prior antibiotic; not recommended due to adverse effect profile)
- Ciprofloxacin-naïve patients with SIBO should first be tried on one of the other listed antibiotics.
Exclusion Criteria
- Known hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any other component of rifaximin.
- No documented benefit from prior rifaximin therapy for SIBO.
- Reoccurrences of SIBO after a durable response (e.g., ≥ 3 months) to one of the listed antibiotic regimens (these reoccurrences should be retreated rather than proceed to rifaximin).
Dosage & Administration
- For SIBO without IBS-D: 200 mg 3 times a day for 7 days to 550 mg 3 times a day for 10 days.
- Clinical study doses range from 200 to 550 mg 3 times a day, with duration often 7 to 10 days (range 5 to 28 days). Optimal dosage regimen has not been determined.
Dispensing Limits & Retreatment Guidelines
- Authorize one course of rifaximin with a maximum dispensing limit of three 200-mg or 550-mg tablets per day for up to 14 days.
- Additional retreatments (renewals or refills) do not require re-evaluation of the patient if an initial course was previously approved.
- Prophylaxis for recurrent SIBO: If the patient benefited from metronidazole or other prior antibiotic therapy, has 4 or more distinct and well-documented SIBO episodes in one year, and has risk factors for recurrent SIBO, that antibiotic may be used for prophylaxis (per separate criteria).
- Rifaximin is not FDA-approved for the treatment of SIBO; it is FDA-approved for IBS-D.