Generic name: fecal microbiota spores, live-brpk
Dosage form: capsules, for oral use
Drug class: Miscellaneous uncategorized agents

Medically reviewed by Melisa Puckey, BPharm. Last updated on Nov 12, 2024.

What is Vowst?

Vowst capsules are used to prevent recurrent Clostridioides difficile infection (C. diff) from coming back after finishing antibiotic treatment for C. difficile infection. Vowst medication contains good live bacteria that restore the balance of the microbiome (gut flora) so that Clostridioides difficile is less likely to overgrow and cause problems. 

Vowst good bacteria are isolated from the stool of qualified donors. The donors are carefully screened and samples are tested routinely during the purification and manufacturing process. 

Recurrent C. diff infection is a gastrointestinal infection caused by C. diff bacteria which can be a highly debilitating and life-threatening disease. When the balance of the microorganisms in the gut is changed (usually after taking a course of antibiotics), Clostridioides difficile can grow and multiply, causing symptoms of watery diarrhea, nausea, abdominal pain, and fever. 

Vowst FDA approval was received on May 2, 2023, to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI). Vowst FDA approval was granted after positive results from Phase 3 development program that included the ECOSPOR III and ECOSPOR IV studies.  Vowst was a collaboration of Nestlé Health Science and Seres Therapeutics, Inc. 

Vowst side effects

The most common Vowst side effects include a bloated abdomen (31%), fatigue (22.2%) constipation (14.4%), chills (11.1%),  and diarrhea (10.0%). These are the side effects that occurred in 5 % or more patients in clinical trials.

These are not all the possible side effects. Be sure to tell your healthcare provider about any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to Aimmune Therapeutics, Inc. at 1-833-246-2566 or FDA at 1-800-FDA-1088 or report online to www.fda.gov/medwatch.

Related/similar drugs

Warnings

Transmissible infectious agents Because Vowst medication is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. If an infection is suspected by a healthcare provider possibly to have been transmitted by this product should be reported by the healthcare provider to Aimmune Therapeutics, Inc. at 1-833-246-2566.

Potential presence of food allergens As this medication is manufactured from human stool it may contain food allergens. The potential for this medication to cause adverse reactions due to food allergens is unknown.

What should I tell my healthcare provider before taking Vowst?

Tell your healthcare provider if you:

• have kidney disease because you may not be able to take the magnesium citrate laxative.
• have any other medical conditions now or have had before.
• take any medicines, including prescription and over-the-counter medicines, vitamins, and supplements.

Pregnancy

Tell your healthcare provider if you are pregnant or planning to get pregnant.

It is not known if Vowst is safe to use during pregnancy.

Breastfeeding

Tell your healthcare provider if you are breastfeeding.

It is not known if Vowst is excreted in breastmilk.

Before you take Vowst

Before you take Vowst, read the information provided and make sure you understand it. If you have questions or experience any side effects, talk to your healthcare provider.

How should I take Vowst?

Vowst treatment involves 3 steps

Step one: Finish antibacterial treatment, then wait 2 to 4 days

Step two: On the day before and at least 8 hours before the first Vowst dose, drink 10 oz (296 mL) of magnesium citrate laxative. Do not eat or drink, except for a small amount of water, for at least 8 hours before taking the first Vowst dose.

Step three: The next day after taking the laxative, take 4 Vowst capsules by mouth on an empty stomach prior to the first meal of the day. Take 4 Vowst capsules by mouth once daily for two more days in a row. Take the capsules on an empty stomach prior to the first meal of the day.

Vowst Dosing information

Usual Adult Dose for Prevention of Recurrence of Clostridioides Difficile Infection (CDI)

4 capsules taken orally once daily for 3 consecutive days. Take capsules on an empty stomach before the first meal of the day

See “How should I take Vowst?” information above.

What other drugs will affect Vowst?

Vowst should not be taken at the same time as antibiotics.

Antibiotics can interfere with the live bacteria contained in Vowst.

Vowst Package Insert

Review the Vowst Package Insert for more detailed information about this medicine. The Package Insert contains more detailed information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you may have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Vowst Package Insert is sometimes called Vowst Prescribing Information (PI) or FDA label.

Storage

• Keep the bottle of capsules either in the refrigerator or at room temperature (36 to 77°F, 2 to 25°C). Do not store in the freezer.
• Do not use Vowst past the expiration date stamped on the carton and the bottle.

Keep all medicines out of the reach of children and pets.

Ingredients

Active ingredient: live bacterial spores
Inactive ingredients: Glycerol, Saline

Company 

Vowst Manufactured by: Seres Therapeutics, Inc. 200 Sidney Street, Cambridge, MA 02139.

Distributed by: Aimmune Therapeutics, Inc., 1007 US Highway 202/206, Bridgewater, NJ 08807.

Vowst Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Vowst.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer