Version May 2024
Note: On the day prior to the first dose, administer a bowel prep according to the manufacturer's directions.
Clostridioides difficile infection, prophylaxis: Oral: 4 capsules once daily for 3 consecutive days, beginning 2 to 4 days after completion of C. difficile treatment regimen (Ref).
There are no dosage adjustments provided in the manufacturer's labeling; however, not expected to be systemically absorbed.
There are no dosage adjustments provided in the manufacturer's labeling; however, not expected to be systemically absorbed.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Gastrointestinal: Abdominal distention (31%), constipation (14%)
Nervous system: Chills (11%)
1% to 10%: Gastrointestinal: Diarrhea (3% to 10%), flatulence (4%), nausea (3%)
There are no contraindications listed in the manufacturer's labeling.
Dosage form specific issues:
• Food allergies: Because product is manufactured from human fecal matter, may contain food allergens; however, potential for the product to cause adverse reactions due to food allergens is unknown.
• Transmissible infectious agents: Manufactured from human fecal matter; may carry risk of transmitting infectious agents. Infections thought to be transmitted by this product should be reported to the manufacturer.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Vowst: Fecal microbiota spores, live-brpk
No
Oral: Swallow capsules whole; do not open, crush, dissolve, or chew.
First dose: Administer a bowel prep according to manufacturer's directions and do not eat or drink, except small amounts of water, for ≥8 hours prior to first dose.
Subsequent doses: Administer on an empty stomach before the first meal of the day.
Clostridioides difficile infection, prophylaxis: Prevention of recurrence of C. difficile infection (CDI) in patients ≥18 years of age following antibiotic treatment of recurrent CDI.
Limitations of use: Not indicated for treatment of CDI.
Fecal microbiota (live) (oral) may be confused with fecal microbiota (live) (rectal).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Antibiotics: Fecal Microbiota (Live) (Oral) may diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Animal developmental toxicity studies have not been conducted.
It is not known if fecal microbiota (live) would be present in breast milk following oral administration.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Do not eat or drink, except small amounts of water, for ≥8 hours prior to first dose. Administer subsequent doses on an empty stomach before the first meal of the day.
Live purified Firmacutes spores modulate bile acid concentrations and restore short chain fatty acids resulting in colonization resistance to C. difficile and restoration of intestinal eubiosis (Martinez-Gili 2020; Soveral 2022).
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