Rebyota

Generic name: (fecal Microbiota, Live-jslm)
Dosage form: suspension, for rectal use
Drug class: Miscellaneous uncategorized agents

Usage of Rebyota

Rebyota is a fecal microbiota product used for the prevention of recurrence of Clostridioides difficile infection (CDI).

Rebyota is a fecal transplant product manufactured from human fecal matter donated by screened individuals. It works by facilitating the restoration of the gut flora to prevent further episodes of Clostridioides difficile infection.

Rebyota is administered rectally 24 to 72 hours after the last dose of antibiotics for the treatment of recurrent CDI.

Rebyota is not indicated for treatment of CDI.

Rebyota has not been studied in patients below 18 years of age.

Rebyota side effects

Common side effects may include:

  • stomach pain
  • diarrhea,
  • bloating,
  • gas, and
  • nausea.
  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088.

    Before taking Rebyota

    Before you receive Rebyota, tell your doctor if you have any food allergies. Rebyota is manufactured from human fecal matter and may contain food allergens, although the potential for the product to cause adverse reactions due to food allergens is unknown.

    Appropriate medical treatment must be immediately available in case you experience an allergic reaction.

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    How to use Rebyota

    Usual Adult Dose for Prevention of Recurrent Clostridioides difficile Infection:

    150 mL administered rectally as a single dose

    Use: prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.

    Warnings

    You should not receive Rebyota if you have a history of a severe allergic reaction to Rebyota or any of its components.

    You should report to your doctor if you think you may have acquired any infection after administration. Rebyota is manufactured from human fecal matter and may carry a risk of transmitting infectious agents.

    You should talk to your doctor about any known food allergies and be prepared should you experience any reaction. Rebyota is manufactured from human fecal matter and may contain food allergens.

    You should not take any oral antibiotic therapy for up to 8 weeks after receiving Rebyota.

    What other drugs will affect Rebyota

    You should not take any oral antibiotic therapy for up to 8 weeks after receiving Rebyota unless directed by your doctor.

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