Fecal Microbiota Spores, Live-brpk
Generic Name: fecal microbiota spores, live-brpk
Brand Names:
Vowst
11 DESCRIPTION VOWST (fecal microbiota spores, live-brpk) is a bacterial spore suspension in capsules for oral administration. VOWST is manufactured from human fecal matter sourced from qualified donors. Human fecal matter donations are routinely tested for a panel of transmissible pathogens. Donors do not have dietary restrictions with respect to potential food allergens.
Overview
11 DESCRIPTION VOWST (fecal microbiota spores, live-brpk) is a bacterial spore suspension in capsules for oral administration. VOWST is manufactured from human fecal matter sourced from qualified donors. Human fecal matter donations are routinely tested for a panel of transmissible pathogens. Donors do not have dietary restrictions with respect to potential food allergens.
Uses
1 INDICATIONS AND USAGE 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). ( 1 ) Limitation of Use: VOWST is not indicated for treatment of CDI. Limitation of Use: VOWST is not indicated for treatment of CDI.
Dosage
2 DOSAGE AND ADMINISTRATION 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). ( 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.
Side Effects
6 ADVERSE REACTIONS 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%). ( 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.
Interactions
7 DRUG INTERACTIONS VOWST contains bacterial spores; therefore, antibacterials should not be administered concurrently with VOWST. Antibacterials should not be administered concurrently with VOWST. ( 7 )
Warnings
5 WARNINGS AND PRECAUTIONS 5.1 Transmissible infectious agents Because VOWST 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. 5.2 Potential presence of food allergens VOWST is manufactured from human fecal matter and may contain food allergens. The potential for VOWST to cause adverse reactions due to food allergens is unknown. 4 CONTRAINDICATIONS None . None. ( 4 )
Pregnancy
8.1 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.
Storage
Store VOWST in the original packaging at 2° to 25°C (36° to 77°F). Do not store in the freezer.
Frequently Asked Questions
What is Fecal Microbiota Spores, Live-brpk used for?▼
1 INDICATIONS AND USAGE 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). ( 1 ) Limitation of Use: VOWST is not indicated for treatment of CDI. Limitation of Use: VOWST is not indicated for treatment of CDI.
What are the side effects of Fecal Microbiota Spores, Live-brpk?▼
6 ADVERSE REACTIONS 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%). ( 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.
Can I take Fecal Microbiota Spores, Live-brpk during pregnancy?▼
8.1 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.
What are the important warnings for Fecal Microbiota Spores, Live-brpk?▼
5 WARNINGS AND PRECAUTIONS 5.1 Transmissible infectious agents Because VOWST 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. 5.2 Potential presence of food allergens VOWST is manufactured from human fecal matter and may contain food allergens. The potential for VOWST to cause adverse reactions due to food allergens is unknown. 4 CONTRAINDICATIONS None . None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.