Vowst (Fecal Microbiota Spores, Live-Brpk)

VOWST is indicated to prevent the recurrence of

• Prior to taking the first dose:
  • Complete antibacterial treatment for rCDI 2 to 4 days before initiating treatment with VOWST. (
    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.
    )
  • 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 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.
    )
• The dosage of VOWST is 4 capsules taken orally once daily for 3 consecutive days. (
  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.
  )
• Take each dose (4 capsules) on an empty stomach prior to the first meal of the day. (
  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.
  )

Capsule. A single dose is 4 capsules.

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.

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.