BISMUTH SUBSALICYLATE SUSP,ORAL
Clinical Criteria Summary
Indication & Patient Population
- Helicobacter pylori (H. pylori) infection
- Treatment-naïve patients
- Treatment-experienced patients with persistent H. pylori despite treatment with optimized bismuth quadruple therapy or vonoprazan dual therapy
Treatment Setting & Line of Therapy
- Suggested as a first-line alternative treatment option for treatment-naïve patients when optimized bismuth quadruple therapy cannot be used
- Suggested as a salvage regimen for treatment-experienced patients with persistent H. pylori; supported by substantial data for rifabutin triple therapy given as individual components for salvage in patients with multiple treatment failures
- Can be administered without the need for susceptibility testing (the only other regimen besides optimized bismuth quadruple therapy that does not require susceptibility testing)
- Supported for use when optimized bismuth quadruple therapy and vonoprazan dual therapy cannot be used or have failed
- Note: The co-formulated combination product has not been studied in treatment-experienced patients; however, the 2024 ACG guidelines suggest it as an alternative to individual components to potentially maximize pharmacokinetics and lower the risk of myelotoxicity
Dosing & Administration
- Co-formulated in a delayed release capsule containing omeprazole, rifabutin, and amoxicillin
- Administer 4 capsules TID with food
- Provides daily doses of 120 mg omeprazole, 150 mg rifabutin, and 2-3 g/day amoxicillin
Precautions & Drug Interactions
- Rifabutin is a known CYP3A4 substrate and inducer; omeprazole inhibits CYP2C19
- Patients must be evaluated for drug-drug interactions prior to prescribing (e.g., azole antifungals, antiretrovirals, warfarin, methotrexate, cyclosporine, tacrolimus)
Formulary Status
- Listed on the VA Formulary as PA-F