FECAL MICROBIOTA-BRPK CAP,ORAL

Clinical Criteria Summary

• Prevention of recurrence of Clostridioides difficile infection (CDI) after completion of antibiotic treatment for recurrent CDI in individuals 18 years of age and older
• Adults with recurrent CDI (rCDI), specifically those with 3 or more episodes within 12 months

• Adjunct therapy following a course of standard CDI antibiotic treatment
• Consider for patients at high risk for rCDI who cannot use bezlotoxumab (e.g., active congestive heart failure or previously treated with bezlotoxumab)
• Bezlotoxumab should generally be tried prior to fecal microbiota therapy unless not medically advisable or practicable
• Ideally, specialists such as Infectious Diseases or Gastroenterology providers should be included in the decision for patient selection and safe use
• Not approved for off-label indications; intent to use off-label requires discussion with local P&T and case adjudication

• Rigorous screening required due to risk of transmitting infectious agents from human fecal matter (e.g., shiga-toxin producing E.coli, extended-spectrum beta-lactamase producing E.coli, norovirus, SARS-CoV-2, monkeypox)
• Potential presence of food allergens
• Not appropriate for patients requiring continued or concomitant antibiotic therapy, as antibiotics may reduce effectiveness and were excluded from clinical trials
• Patients with toxic megacolon, history of active inflammatory bowel disease within 3 months, or absolute neutrophil count < 500 cells/uL were excluded from trials; efficacy in these populations cannot be determined

• Initiate 2-4 days after completion of CDI treatment
• Dose: 4 capsules taken orally once daily for 3 consecutive days on an empty stomach prior to the first meal of the day
• Pre-treatment requirement: 296 mL magnesium citrate the day before the first dose (or 250 mL polyethylene glycol if unable to take magnesium citrate)
• Patients must be able to comply with administration procedures and laxative pretreatment

• Pregnancy: No data on use in pregnant individuals
• Lactation: Unknown whether excreted in human milk
• Geriatrics: Clinical trial data are not sufficient to determine if adults 65 years of age or greater respond differently than younger adults

History of severe allergic reactions to any component of VOWST
Asymptomatic Clostridioides difficile colonization
Absolute neutrophil count < 500 cells/mm3
Likely to require antibiotic therapy for a condition other than Clostridioides difficile infection (CDI) OR planned surgery requiring perioperative antibiotics within 8 weeks after treatment
Inability to use magnesium citrate or polyethylene glycol pretreatment or comply with administration on an empty stomach prior to the first meal of the day

At least 2nd episode of recurrent CDI (3rd episode overall) in the previous 12 months (defined as CDI recurring within 8 weeks of completion of standard CDI treatment)
Successful treatment of current episode of CDI with standard of care CDI antibiotics (fidaxomicin or oral vancomycin)
Administration occurs within 2-4 days after completion of standard of care CDI antibiotics (fidaxomicin or oral vancomycin)
At least one episode of CDI was treated with fidaxomicin, unless not tolerated or contraindicated

Pretreatment: 296 mL magnesium citrate on the day before and at least 8 hours prior to the FIRST dose (250 mL polyethylene glycol can be used as an alternative in patients with impaired kidney function)
Fasting requirement: No food or drink, except a small amount of water, for at least 8 hours prior to the FIRST dose
Dosing regimen: 4 capsules orally on an empty stomach prior to the first meal of the day once daily for 3 consecutive days

Not FDA indicated or studied for an initial episode of CDI
Should be avoided in patients with an absolute neutrophil count < 500 cells/mm3 (further data required before making a recommendation in this population)