Vowst
Generic name: fecal microbiota spores, live-brpk
Dosage form: capsules, for oral use
Drug class: Miscellaneous uncategorized agents
What is Vowst?
Vowst is a prescription medicine used in adults to prevent Clostridioides difficile infection (CDI) from coming back after completion of antibiotic treatment for C. difficile infection.
Vowst is an oral microbiome therapeutic consisting of live bacteria. It is manufactured from human fecal matter sourced from qualified donors.
Vowst works to treat CDI by restoring the microbiome (gut flora) back to a balance that resists Clostridioides difficile colonization and growth.
What is Vowst used to treat?
Vowst is used to prevent the recurrence of CDI in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
CDI is caused by the bacterium Clostridioides difficile. 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 is not intended for treatment of Clostridioides difficile infection.
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 is taken over three consecutive days.
Before you take Vowst:
- 2 to 4 days before your first dose of Vowst, finish your antibiotic treatment for C. difficile infection.
- On the day before and at least 8 hours prior to the first dose, drink 10 oz (296 mL) of magnesium citrate laxative.
- Do not eat or drink, except for small amount of water, for at least 8 hours prior to taking the first dose.
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.
Swallow each capsule whole. DO NOT crush, chew, or break the capsules.
Dosing information
Usual Adult Dose for Prevention of Recurrence of Clostridioides Difficile Infection (CDI)
4 capsules taken orally once daily for 3 consecutive days.
Comments:
-Prior to taking the first dose: Complete antibacterial treatment for rCDI 2 to 4 days before initiating treatment with Vowst. Drink 296 mL (10 oz) of magnesium citrate on the day before and at least 8 hours prior to taking the first dose. Take each dose (4 capsules) on an empty stomach prior to the first meal of the day.
Use:
- to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
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.
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.
Vowst side effects
The most common side effects include:
- bloated abdomen
- fatigue
- constipation
- chills
- diarrhea
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.
How should I store Vowst?
- 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.
What are the ingredients in Vowst?
Active ingredient: live bacterial spores
Inactive ingredients: Glycerol, Saline
References
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.