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Patient, Caregivers and Healthcare Professionals For medical/product information, product complaints, report a side effect or adverse events and other service needs relating to VOWST, please contact Aimmune Therapeutics at 1-833-AIM2KNO (1-833-246-2566). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
VOWST is 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).
Limitation of Use: VOWST is not indicated for treatment of CDI.
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For oral administration only.
o Complete antibacterial treatment for rCDI 2 to 4 days before initiating treatment with VOWST.
o Drink 296 mL (10 oz) of magnesium citrate on the day before and at least 8 hours prior to taking the first dose of VOWST. In clinical studies, participants with impaired kidney function received polyethylene glycol electrolyte solution (250 mL GoLYTELY, not approved for this use).
Capsule. A single dose is 4 capsules.
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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%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics, Inc. at 1-833-246-2566 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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Antibacterials should not be administered concurrently with VOWST.
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SERES and the Seres logo, VOWST, VOWST Voyage, and the Vowst logo are trademarks of Seres Therapeutics, Inc. Unless otherwise indicated, all trademarks are owned by Société des Produits Nestlé S.A., Vevey, Switzerland or used with permission.
GoLYTELY is a registered trademark of Braintree Laboratories, Inc.
© 2024 Nestlé. VOW-PM-USA-0242 01/24
Click here to see full Prescribing Information and Patient Information.
INDICATION
VOWST is 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).
Limitation of Use: VOWST is not indicated for treatment of CDI.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Transmissible infectious agents: Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.
Potential presence of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.
ADVERSE REACTIONS
The most common adverse reactions (reported in ≥5% of Vowst-treated participants, and at a rate greater than placebo) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%).
To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO
(1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.
DRUG INTERACTIONS
Do not administer antibacterials concurrently with VOWST.
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