Becker's Clinical Quality & Infection Control


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RESTORE HOPE a In the pivotal phase 3 trial, 32.8% of patients were treated at first recurrence of CDI following antibiotic treatment of CDI. 1 Where dysbiosis once left the gut microbiome in ruin, RISE ABOVE RECURRENT C. DIFFICILE INFECTION and restore hope with REBYOTA TM The first and only FDA-approved microbiota-based live biotherapeutic to prevent recurrence of C. difficile infection starting at first recurrence. 1,2,a Scan to visit website 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. All rights reserved. US-REB-2200129 1/23 INDICATION REBYOTA (fecal microbiota, live - jslm) is indicated for the prevention of recurrence of Clostridioides diff icile 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 f rom 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 f rom 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 eff icacy 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 f rom clinical studies of REBYOTA are not suff icient 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, or call 1-800-332-1088. Please see Brief Summary on next page and full Prescribing Information at References 1. REBYOTA. Prescribing Information. Parsippany, NJ: Ferring Pharmaceuticals; 2022. 2. US Food and Drug Administration. FDA Approves First Fecal Microbiota Product. https:// announcements/fda-approves-f irst- fecal-microbiota-product. Accessed December 1, 2022.

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