VOWST (fecal microbiota spores, live-brpk), formerly SER-109, is the first and only FDA-approved orally administered microbiota-based therapeutic indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
Limitations of use: VOWST is not indicated for the treatment of CDI.
IMPORTANT SAFETY INFORMATION
The most common adverse reactions (reported in ≥ 5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%). To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.
See below for Full Prescribing Information.
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