Fecal Microbiota Spores, Live-brpk (Monograph)

Brand name: Vowst
Drug class: GI Drugs, Miscellaneous

Medically reviewed by Drugs.com on May 10, 2024. Written by ASHP.

Introduction

Fecal microbiota spores, live-brpk is a bacterial spore suspension in capsules prepared from human fecal matter sourced from qualified donors.

Uses for Fecal Microbiota Spores, Live-brpk

Fecal microbiota spores, live-brpk has the following uses:

Fecal microbiota spores, live-brpk 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.

The Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) has published guidelines on the management of CDI. The guidelines state that fecal microbiota transplantation (FMT) is recommended only for patients with multiple recurrences of CDI who have failed appropriate antibiotic treatments and where appropriate screening of donor and donor fecal specimens has been performed.

Fecal microbiota spores, live-brpk is not indicated for treatment of CDI.

Fecal Microbiota Spores, Live-brpk Dosage and Administration

General

Fecal microbiota spores, live-brpk is available in the following dosage form(s) and strength(s):

Bacterial spore suspension in capsules; each capsule contains between 1×10⁶ and 3×10⁷ Firmicutes spore colony forming units (CFU) in 92 ± 4% (w/w) glycerol in saline.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

For oral administration only.

Prior to taking the first dose, complete antibacterial treatment for recurrent CDI 2 to 4 days before initiating treatment with fecal microbiota spores, live-brpk.

Drink 296 mL (10 oz) of magnesium citrate on the day before and at least 8 hours prior to taking the first dose of fecal microbiota spores, live-brpk. In clinical studies, participants with impaired kidney function received polyethylene glycol electrolyte solution (250 mL GoLYTELY, not approved for this use).

Do not eat or drink, except for small amount of water, for at least 8 hours prior to taking the first dose.

The dosage of fecal microbiota spores, live-brpk 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.

Cautions for Fecal Microbiota Spores, Live-brpk

Contraindications

None.

Warnings/Precautions

Transmissible Infectious Agents

Because fecal microbiota spores, live-brpk is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Any infection 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

Fecal microbiota spores, live-brpk is manufactured from human fecal matter and may contain food allergens. The potential for fecal microbiota spores, live-brpk to cause adverse reactions due to food allergens is unknown.

Specific Populations

Pregnancy

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 fecal microbiota spores, live-brpk in pregnant individuals. Developmental toxicity studies in animals have not been conducted with fecal microbiota spores, live-brpk.

Lactation

It is not known whether fecal microbiota spores, live-brpk is excreted in human milk. Data are not available to assess the effects of fecal microbiota spores, live-brpk on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for fecal microbiota spores, live-brpk and any other potential adverse effects on the breastfed child from fecal microbiota spores, live-brpk or from the underlying maternal condition.

Pediatric Use

The safety and effectiveness of fecal microbiota spores, live-brpk in individuals younger than 18 years of age have not been established.

Geriatric Use

Of the 349 adults who received fecal microbiota spores, live-brpk, 52.4% were ≥65 years of age (n=183), and 28.1% were ≥75 years of age (n=98). Data from clinical studies of fecal microbiota spores, live-brpk are not sufficient to determine if adults ≥65 years of age respond differently than younger adults.

Common Adverse Effects

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%).

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Antibacterials should not be administered concurrently with fecal microbiota spores, live-brpk.

Actions

Mechanism of Action

The mechanism of action of fecal microbiota spores, live-brpk has not been established.

Advice to Patients

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform patients not to take fecal microbiota spores, live-brpk concurrently with antibacterials.

Additional Information

AHFSfirstRelease^™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.