Rebyota has confirmed >90% coverage for commercially and government-insured patients.* Learn More
REBYOTA is the first and only single-dose microbiota-based live biotherapeutic approved to prevent recurrence of C. difficile infection starting at first recurrence1,2,a
aIn the pivotal phase 3 trial, 32.8% of patients were treated at first recurrence of C. diff infection (CDI) following antibiotic treatment of CDI.1
REBYOTA ADMINISTRATION—ONE DOSE.
ONE COMPLETE MICROBIOME-BASED BIOTHERAPEUTIC
Efficient delivery: REBYOTA is a pre-packaged 150-mL suspension that is rectally administered in any site of care by a healthcare professional.1
- No bowel prep/laxatives, fasting, anesthesia, or colonoscopy required3
- Conveniently order REBYOTA on-demand
- After administration, keep patient in position for up to 15 minutes to minimize possible cramping after which they can go home1
REBYOTA ADMINISTRATION HIGHLIGHTS1
BEFORE
- Request that patient empty bladder and bowel, if possible
- Place patient in the preferred position: either a left-side or knee-chest position
DURING
- Lubricate and insert the administration tube about 5 inches pointed slightly toward the navel
- Hold the administration tube, with other hand open pinch clamp
- Gradually raise, allow REBYOTA to flow via gravity
AFTER
- Withdraw tube
- Keep patient in position for up to 15 minutes to minimize possible cramping
- It is normal for some product to remain in tube; does not affect treatment
- No specified cleaning of facility in phase 3 trial protocol
IMPORTANT CONSIDERATIONS
- DO NOT administer REBYOTA during antibiotic treatment for CDI
- Administer REBYOTA 24 to 72 hours after the last dose of antibiotics
REBYOTA
ADMINISTRATION VIDEO
Watch this video to learn how to administer REBYOTA through instructional and simulated administration.

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Ordering Instructions
There are multiple ways to order REBYOTA: through major specialty distributors, REBYOTA @ Home, or specialty pharmacies.
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IMPORTANT SAFETY INFORMATION
INDICATION
REBYOTA (fecal microbiota, live – jslm) is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.
Limitation of Use
REBYOTA is not indicated for treatment of CDI.
IMPORTANT SAFETY INFORMATION
Contraindications
Do not administer REBYOTA to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any of the known product components.
Warnings and Precautions
Transmissible infectious agents
Because REBYOTA is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Any infection suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Ferring Pharmaceuticals Inc.
Management of acute allergic reactions
Appropriate medical treatment must be immediately available in the event an acute anaphylactic reaction occurs following administration of REBYOTA.
Potential presence of food allergens
REBYOTA is manufactured from human fecal material and may contain food allergens. The potential for REBYOTA to cause adverse reactions due to food allergens is unknown.
Adverse Reactions
The most commonly reported (≥3%) adverse reactions occurring in adults following a single dose of REBYOTA were abdominal pain (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%).
Use in Specific Populations
Pediatric Use
Safety and efficacy of REBYOTA in patients below 18 years of age have not been established.
Geriatric Use
Of the 978 adults who received REBYOTA, 48.8% were 65 years of age and over (n=477), and 25.7% were 75 years of age and over (n=251). Data from clinical studies of REBYOTA are not sufficient to determine if adults 65 years of age and older respond 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 here for full Prescribing Information.
References
- Rebyota. Prescribing Information. Parsippany, NJ: Ferring Pharmaceuticals Inc; 2022.
- US Food and Drug Administration. FDA Approves First Fecal Microbiota Product. Accessed December 1, 2022. https://www.ferring.com/ferring-receives-u-s-fda-approval-for-rebyota-fecal-microbiota-live-jslm-a-novel-first-in-class-microbiota-based-live-biotherapeutic/
- 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. doi:10.1007/s40265-022-01797-x.