Omontys (Peginesatide) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2012
Serious allergic reactions to OMONTYS which may include anaphylaxis
WARNINGS AND PRECAUTIONS
Serious Allergic Reactions
Serious allergic reactions, including anaphylactic reactions, hypotension, bronchospasm, angioedema and generalized pruritus, may occur in patients treated with Omontys. Immediately and permanently discontinue Omontys and administer appropriate therapy if a serious allergic reaction occurs.