The first fecal microbiota product for prevention of recurrence of Clostridioides difficile infection (CDI), also referred to as Clostridium difficile infection, in adult patients, has been approved by the US Food and Drug Administration (FDA). Marketed by the name of Rebyota (fecal microbiota, live-jslm), the product is intended for use after completing the antibiotic course for recurrent CDI. However, it is not indicated for treatment of CDI. It is meant for rectal administration only.

Rebyota is prepared from fecal matter sourced from pre-screened qualified donors.

Formulation: Suspension

Dose & Administration: Single 150 mL dose administered rectally 24 to 72 hours after the last dose of antibiotics for CDI.

Contraindication: Severe allergic reactions to any component of the product

Adverse effects: Abdominal pain, diarrhea, abdominal distention, flatulence, nausea

Warning and precautions: There is a potential risk of transmitting infectious pathogens since it is prepared from human fecal matter, although the donor and the donated stool are tested for a panel of transmissible pathogens. It may also contain food allergens.

Sources

1. FDA News Release, November 30, 2022.
2. Rebyota Prescribing Information. Available at: https://www.ferringusa.com/wp-content/uploads/sites/12/2022/11/rebyota-package-insert-pdf-11.2022.pdf