Fecal microbiota spores, live-brpk

What Fecal microbiota spores, live-brpk is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

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). 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 …

— FDA label: Vowst, Aimmune Therapeutics, Inc., effective April 23, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (capsule, oral), Vowst, Aimmune Therapeutics, Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Fecal microbiota spores, live-brpk side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

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%). 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%).

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(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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of VOWST was evaluated in one Phase 3, randomized, double-blind clinical study (Study 1: NCT03183128) and one Phase 3, open-label clinical study (Study 2: NCT03183141) conducted in the United States and Canada. Adults with confirmed rCDI were required to have symptoms controlled 48 to 96 hours post-antibacterial treatment to be eligible for enrollment and randomization (1:1) to receive either VOWST or placebo (capsules containing 92 ± 4% glycerol in saline) for 3 consecutive days. Participants with neutropenia (absolute neutrophil count of <500 cells/mm 3), toxic megacolon, or small bowel ileus were excluded from these studies. A total of 349 adults 18 years of age and older with rCDI were exposed to VOWST across both Study 1 (n=90) and Study 2 (n=259). Across both Study 1 and Study 2, 99.1% of adults (346/349) received all scheduled doses of VOWST. Overall, across the 2 studies, the median age of VOWST recipients was 66 years (range, 21-100 years). The racial and ethnic distribution was as follows: 92.3% were white and 5.2% were black. In Study 1, females comprised 68.9% of the VOWST arm compared to 51.1% in the placebo arm. Rates of the following comorbidities (at study entry) were similar across the VOWST and placebo arms: cardiac disease (33.3% and 31.5%, respectively), immunocompromise/immunosuppression (28.9% and 30.4%, respectively), diabetes (20.0% and 27.2%, respectively), and renal impairment (14.4% and 15.2%, respectively). In Study 2, 68.4% were females and representation of comorbidities was similar to Study 1. Adverse Reactions In Study 1, participants recorded solicited adverse events in a diary for 7 days after completion of the 3-day regimen of VOWST or placebo. In both Study 1 and Study 2, participants were monitored for unsolicited adverse events by queries during weekly encounters for a period of 8 weeks. Monitoring for serious adverse events and adverse events of special interest (i.e., invasive infections) continued for a period of 6 months after the first dose of study drug. In Study 1, a multi-center, double-blind randomized (1:1), placebo-controlled trial conducted in the United States and Canada, adults 18 years of age and older (range: 18 to 100 years of age) received three daily doses of VOWST (n=90) or placebo (n=92).

— FDA label: Vowst, Aimmune Therapeutics, Inc., effective April 23, 2026. This is part of the section. Read the full label on DailyMed →

Fecal microbiota spores, live-brpk drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

VOWST contains bacterial spores; therefore, antibacterials should not be administered concurrently with VOWST. Antibacterials should not be administered concurrently with VOWST. (7)

— FDA label: Vowst, Aimmune Therapeutics, Inc., effective April 23, 2026. Read the full label on DailyMed →

Fecal microbiota spores, live-brpk dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

For oral administration only. (2) Prior to taking the first dose: Complete antibacterial treatment for rCDI 2 to 4 days before initiating treatment with VOWST. (2.1) 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).

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(2.1) The dosage of VOWST is 4 capsules taken orally once daily for 3 consecutive days. (2.2) Take each dose (4 capsules) on an empty stomach prior to the first meal of the day. (2.2) 2.1 Prior to taking the first dose Complete antibacterial treatment for recurrent CDI 2 to 4 days before initiating treatment with VOWST. Drink 296 mL (10 oz) 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) [see Clinical Studies (14)]. Do not eat or drink, except for small amount of water, for at least 8 hours prior to taking the first dose. 2.2 Dosing regimen The dosage of VOWST is 4 capsules taken orally once daily for 3 consecutive days. Take each dose (4 capsules) on an empty stomach prior to the first meal of the day.

— FDA label: Vowst, Aimmune Therapeutics, Inc., effective April 23, 2026. Read the full label on DailyMed →

Fecal microbiota spores, live-brpk in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no data on use of VOWST in pregnant individuals. Developmental toxicity studies in animals have not been conducted with VOWST.

— FDA label: Vowst, Aimmune Therapeutics, Inc., effective April 23, 2026. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Aimmune Therapeutics, Inc.1 product

FDA approval history

• BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Vowst, Aimmune Therapeutics, Inc., effective April 23, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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