When the gut microbiome is in ruin,
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
40% to 65% of patients with rCDI may experience a subsequent recurrence.1,3
Antibiotics are the standard of care for CDI, but they don’t address the underlying microbiome disruption that leads to subsequent recurrence.4
REBYOTA is the only FDA-approved therapy that provides trillions of live Bacteroides and Firmicutes to help restore a healthy gut microbiome and prevent a CDI recurrence.1,7,8
REBYOTA is administered directly where it is needed—the gut microbiome.
Bacteroidetes (of which Bacteroides are an important group) and Firmicutes9:
One dose of REBYOTA provides1:
15 BILLION TO
7.5 TRILLION
colony-forming units (CFU)
of live fecal microbes
The mechanism of action of REBYOTA has not been established.1 It is believed that Fecal Microbiota Transplant affects repopulation and restoration of the composition and diversity of the gut microbiome. It suppresses C. diff overgrowth and prevents recurrence.10
of recurrent C. diff patients may experience a subsequent recurrence. REBYOTA is an important preventative measure to help stop C. diff from coming back.8,9
REBYOTA®: 150-mL suspension, rectally administered by a healthcare professional1
No bowel prep or fasting required11
Proprietary and GMP-adherent11
Filtrate produced via a proprietary manufacturing process following Good Manufacturing Practice (GMP)
Screening13
Consistent, rigorous health and pathogen screening and testing
No pooling11
Just single-donor traceability
Preserved live fecal microbes14
Cryogenically preserved until ready for use
“I just knew that if I had C. diff again,
I wasn’t going to survive. But my C. diff didn’t
come back after I had REBYOTA.”
FREDA, age 70s
Actual PUNCH™ CD3 Trial Patient. Freda was compensated for her time. Individual results may vary.
Freda loves traveling to visit family, spending time with her husband on their farm, and caring for their bees and chickens.
She was hospitalized for severe
CDI symptoms—several days after she received antibiotics for a toothache.
After 4 severe recurrences, she and her husband feared for her life.
Most common adverse reactions include abdominal pain (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%).1
“I got a manicure and went shopping!”
Individual results may vary.
Most common adverse reactions include abdominal pain (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%).1
“Had REBYOTA been available sooner,
I would have asked for it.”
MELISSA, age 40s
Actual PUNCH™ CD3 Trial Patient. Melissa was compensated for her time. Individual results may vary.
Melissa lives a busy life, balancing marriage, a career, pets, creative writing, and being social—all while staying active and healthy.
However, her life shifted drastically when she was diagnosed with CDI.
Chronic fatigue and nutritional deficiencies became her new normal.
Most common adverse reactions include abdominal pain (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%).1
“I made dinner for the family for the first time in months.”
Individual results may vary.
Most common adverse reactions include abdominal pain (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%).1
“For me, it was one dose and one visit,
and that was it.”
PATRICIA, age 30s
Actual PUNCH™ CD3 Trial Patient. Patricia was compensated for her time. Individual results may vary.
Patricia is a doting, working mother of two, who loves activities like playtime and tea parties with her kids.
After a wave of severe symptoms disrupted her daily routine, she was diagnosed with CDI.
When it recurred, she was isolated inside, unable to play with her children, and ashamed to talk about her symptoms.
Most common adverse reactions include abdominal pain (8.9%), diarrhea (7.2%), abdominal distension (3.9%), flatulence (3.3%), and nausea (3.3%).1
“I was finally able to tuck my girls into bed again.
I read them a story and had lots of snuggles.”
Individual results may vary.
Most common adverse reactions include abdominal pain (8.9%), diarrhea (7.2%), abdominal distension (3.9%), flatulence (3.3%), and nausea (3.3%).1
“The administration for me was simple and easy. Only took a few minutes.”
PAT, age 60s
REBYOTA Patient. Pat was compensated for his time.
Individual results may vary.
Pat enjoys spending weekends at his remote cabin, working on his collection of classic cars, or surrounded by his wife, 2 daughters, and his 3 grandchildren.
After battling severe symptoms on vacation in Mexico, Pat sought medical help to find the cause.
Putting his life on pause after
3 recurrences, Pat’s wife Jill, a gastrointestinal nurse, advocated
for REBYOTA.
Most common adverse reactions include abdominal pain (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%).1
“I was able to push play on my life and get back to doing the things I love.”
Individual results may vary.
Most common adverse reactions include abdominal pain (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%).1
Explore clinical data evaluating the efficacy and safety of REBYOTA for the prevention of recurrent CDI.
Learn how to administer REBYOTA—one dose, one complete microbiome-based biotherapeutic.
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.
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.