Rebyota (fecal microbiota, live-jslm) · Ferring Pharmaceuticals Inc.

The effectiveness of REBYOTA was evaluated using a Bayesian analysis of data from a randomized, double-blind, placebo-controlled, multicenter Phase 3 study (Study 1), which formally integrated treatment success rates from a placebo-controlled Phase 2 study (Study 2). Enrolled adults in both studies were 18 years of age or older and had a confirmed diagnosis of recurrent CDI (one or more episodes in Study 1; two or more episodes in Study 2) which was defined as diarrhea (passage of 3 or more loose bowel movements within a 24-hour period for 2 consecutive days) and a positive stool test for C. d...

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%). 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%) ( Table 1 ). To report SUSPECTED ADVERSE REACTIONS, contact F...

Do not administer REBYOTA to individuals with a history of a severe allergic reaction (e.g. anaphylaxis) to any of the known product components [see Description 11 ] . Severe allergic reactions (e.g. anaphylaxis) to any component of REBYOTA. ( 4 )

5.1 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. 5.2 Management of acute allergic reactions Appropriate medical treatment must be immediately available in the event an acute anaphylactic reaction occurs following adm...