Budget Impact Analysis of REBYOTA for Preventing Recurrent Clostridioides difficile Infection in the US

Do not administer REBYOTA to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any of the known product components.

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.

Appropriate medical treatment must be immediately available in the event an acute anaphylactic reaction occurs following administration of REBYOTA.

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.

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%).

Safety and efficacy of REBYOTA in patients below 18 years of age have not been established.

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.