Becker's Clinical Quality & Infection Control

REBYOTA TM (fecal microbiota, live - jslm) suspension, for rectal use Brief Summary Please consult package insert for full Prescribing Information INDICATIONS REBYOTA 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 (e.g. anaphylaxis) to any of the known product components. Each 150mL dose of REBYOTA contains between 1x10 8 and 5x10 10 colony forming units (CFU) per mL of fecal microbes including >1x10 5 CFU/mL of Bacteroides, and contains not greater than 5.97 grams of PEG3350 in saline. 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 matter 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%). Clinical Trials Experience: The safety of REBYOTA was evaluated in 2 randomized, double-blind clinical studies (Study 1 and Study 2) and 3 open-label clinical studies conducted in the United States and Canada. A total of 978 adults 18 years of age and older with a history of 1 or more recurrences of Clostridioides difficile (CDI) infection and whose symptoms were controlled 24 – 72 hours post-antibiotic treatment were enrolled and received 1 or more doses of REBYOTA; 595 of whom received a single dose of REBYOTA. Adverse Reactions: Across the 5 clinical studies, participants recorded solicited adverse events in a diary for the first 7 days after each dose of REBYOTA or placebo. Participants were monitored for all other adverse events by queries during scheduled visits, with duration of follow-up ranging from 6 to 24 months after the last dose. In an analysis of solicited and unsolicited adverse events reported in Study 1, the most common adverse reactions (defined as adverse events assessed as definitely, possibly, or probably related to Investigational Product by the investigator) reported by ≥3% of REBYOTA recipients, and at a rate greater than that reported by placebo recipients, were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%).Most adverse reactions occurred during the first 2 weeks after treatment. After this, the proportion of patients with adverse reactions declined in subsequent 2-week intervals. Beyond 2 weeks after treatment only a few single adverse reactions were reported. Most adverse drug reactions were mild to moderate in severity. No life-threatening adverse reaction was reported. Serious Adverse Reactions - In a pooled analysis of the 5 clinical studies, 10.1% (60/595) of REBYOTA recipients (1 dose only) and 7.2% (6/83) of placebo recipients reported a serious adverse event within 6 months post last dose of investigational product. None of these events were considered related to the investigational product. USE IN SPECIFIC POPULATIONS Pregnancy: REBYOTA is not absorbed systemically following rectal administration, and maternal use is not expected to result in fetal exposure to the drug. Lactation: REBYOTA is not absorbed systemically by the mother following rectal administration, and breastfeeding is not expected to result in exposure of the child to REBYOTA. Pediatric Use: Safety and effectiveness of REBYOTA in individuals younger than 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 For more information, visit www.REBYOTAHCP.com You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch, or call 1-800-332-1088. Manufactured for Ferring Pharmaceuticals by Rebiotix, Inc. Roseville, MN 55113 US License No. 2112 9009000002 Rx Only Ferring and the Ferring Pharmaceuticals logo are registered trademarks of Ferring B.V. REBYOTA is a trademark of Ferring B.V. ©2022 Ferring B.V. This brief summary is based on full Rebyota Prescribing Information which can be found at www.RebyotaHCP.com US-REB-2200277

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