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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.