FECAL MICROBIOTA-JSLM SUSP,RTL

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
• Not indicated for the treatment of active CDI
• Applicable to adults with recurrent CDI (rCDI), defined as beginning within 8 weeks after treatment for a primary episode
• Patients must have completed at least 10 days of antibiotics for CDI with symptoms controlled (< 3 loose stools per day)

• Rectal enema, suspension: single 150 mL dose for rectal administration
• Typically administered 24-72 hours after receipt of antibiotic treatment for CDI
• Oral antibiotics should be avoided for up to 8 weeks after use

• Contraindicated in patients with severe allergic reactions (e.g., anaphylaxis) to any component of REB
• Carries risk for transmitting infectious agents; requires rigorous screening and appropriate patient selection
• Avoid use in patients with immune compromise, including those on corticosteroids (≥ 20mg/day prednisone or equivalent), absolute neutrophil count < 1000 cells/uL, or other conditions/therapies causing a compromised immune system
• Appropriate treatment for acute allergic reactions must be available following administration due to potential anaphylactic reaction risk
• May contain food allergens as it is manufactured from human fecal matter

• Pregnancy: Not absorbed systemically following rectal administration; maternal use not expected to result in fetal exposure
• Lactation: Breastfeeding is not expected to result in exposure of the child to REB
• Geriatrics: Clinical trial data are insufficient to determine if adults 65 years of age or greater respond differently than younger adults

• Store carton in ultracold freezer (−60°C to −90°C) upon receipt, or refrigerated at 2°C to 8°C for up to 5 days including thaw time; do not refreeze
• Store administration set separately at 10°C to 34°C; do not store in the freezer

• Intended as adjunct therapy following a course of standard CDI antibiotic therapy
• Specialists (e.g., Infectious Diseases or Gastroenterology providers) should be included in the decision to use REB to ensure appropriate patient selection and safe use
• Not approved for use in other gastrointestinal or non-GI conditions (e.g., IBD, IBS)

History of severe allergic reactions to any component of REBYOTA
Asymptomatic Clostridioides difficile colonization
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
Severe immunosuppression (includes neutropenia, early post solid organ or peripheral blood stem cell transplant, or equivalent degree of immunosuppression from other diseases or medications)

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 PO vancomycin)
Administration within 1-3 days after completion of standard of care CDI antibiotics (fidaxomicin or PO vancomycin)
At least one episode of CDI was treated with fidaxomicin, unless not tolerated or contraindicated

Single dose of 150 mL rectally as an enema, 24-72 hours after the last dose of antibiotics for CDI

Not studied and not FDA indicated for an initial episode of CDI
Should be avoided in immunocompromised patients; further data required before making a recommendation in this population