What is REBYOTA?
REBYOTA is the first and only single-dose, FDA-approved microbiome-based therapy to keep recurrent C. diff infection from coming back, after you’ve already taken antibiotics.1
REBYOTA is…
A microbiome-based therapy
REBYOTA is a microbiome- based therapy to keep recurrent C. diff infection from coming back. It is not an antibiotic.1
A mix of important bacteria
REBYOTA is made up of a consistent mix of important bacteria.1
Delivered where it’s needed
In one dose and one visit, REBYOTA is delivered right where it’s needed—your gut microbiome.
Administered within minutes
REBYOTA is administered within minutes, and unlike other options, it does not require laxatives/bowel prep, fasting, anesthesia, or colonoscopy.2
In a major clinical study with REBYOTA1,a:
REBYOTA After
Antibiotics
71%
success rate1,b
Antibiotics
Alone
58%
success rate1,b
Of those patients who saw success with REBYOTAb…
~90% stayed free of C. diff at 6 months.2
Most common side effects may include stomach pain (8.9%), diarrhea (7.2%), bloating (3.9%), gas (3.3%), and nausea (3.3%).1 In clinical studies, there were no serious adverse events related to REBYOTA.1
aThe study was conducted in approximately 300 adult patients with recurrent C. diff infection for up to 8 weeks to find out how well REBYOTA prevented recurrent C. diff infection. Patients in this study first completed treatment with antibiotics.1,2
bSuccess rate indicates no other recurrence of C. diff infection at 8 weeks.2
Download the REBYOTA patient brochure
Learn more about recurrent C. diff infection and how REBYOTA keeps it from coming back.
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Getting REBYOTA
Learn how REBYOTA can be administered at your doctor’s office or in your home.
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References
- REBYOTA. Prescribing Information. Parsippany, NJ: Ferring Pharmaceuticals Inc; 2022.
- Khanna S, Assi M, Lee C, et al. Efficacy and safety of RBX2660 in PUNCH CD3, a phase III, randomized, double blind, placebo controlled trial with a Bayesian primary analysis for the prevention of recurrent Clostridioides difficile infection. Drugs. 2022;82(15):1527-1538.
Please see Important Safety Information and full Prescribing Information
INDICATION
REBYOTA (fecal microbiota, live – jslm) is indicated for the prevention of recurrence of Clostridioides difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection.
Limitation of Use
REBYOTA is not indicated for the treatment of C. diff infection.
Important Safety Information
- You should not receive REBYOTA if you have a history of a severe allergic reaction (e.g., anaphylaxis) to REBYOTA or any of its components.
- You should report to your doctor any infection you think you may have acquired after administration.
- REBYOTA may contain food allergens.
- Most common side effects may include stomach pain (8.9%), diarrhea (7.2%), bloating (3.9%), gas (3.3%), and nausea (3.3%).
- REBYOTA has not been studied in patients below 18 years of age.
- Clinical studies did not determine if adults 65 years of age and older responded differently than younger adults.
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088.
Please click to see the full Prescribing Information.