Biocare Infusion Center is now a preferred site for Rebyota® administration. Access the Rebyota® Drug Order form via Rebyota Order Form. Additional order forms for infusions to manage other GI conditions can be found here Order Forms.
REBYOTA® is indicated for preventing recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI. (Refer to the link above for full prescribing information).
C.difficile, a superbug that can cause serious and life-threatening diarrhea. According to the FDA, the infection causes about 500,000 illnesses and is associated with 15,000 to 30,000 deaths annually in the US.
The use of certain antibiotics can contribute to infection caused by C. difficile as certain antibiotics can disrupt the balance of bacteria in the gut, allowing bacteria like C. difficile to multiply and release toxins to cause diarrhea quickly. A weakened immune system, being over the age of 65, and hospitalization can also increase susceptibility to CDI.
The risk of recurrence increases with each infection and treatment options for recurrent CDI are limited. The administration of fecal microbiota is thought to facilitate restoration of the gut flora to prevent further episodes of CDI. Rebyota® is not indicated for the first occurrence of C. difficile.
Rebyota® is delivered via enema and is designed to help restore bacterial balance in the gut. It is formulated by extracting gut microorganisms from human stool donated by individuals who qualify as donors. Despite testing both donors and the donated stool for transmissible pathogens, there is still a risk of transferring infectious agents through the therapy. Additionally, Rebyota® could contain food allergens, which poses an unknown risk for food allergen-related adverse reactions.
The FDA’s approval of Rebyota® was granted based on data from a clinical trial program that consisted of six studies involving 1,061 participants, 978 of whom were treated with Rebyota®. Of those who received the treatment, 70 percent were cleared of infection within eight weeks compared with 58 percent in the placebo group.
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Reference
Rebyota® prescribing information- accessed online 1/20/24 via Package Insert – REBYOTA (fda.gov)
FDA Approves Rebyota as First Fecal Microbiome Therapy for Recurrent C. Difficile Infection – Xtalks. Link accessed online 1/20/24
