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U.S. Department of Health and Human Services

Safety

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Omontys (Peginesatide) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2012

Summary View

 

CONTRAINDICATIONS

  • 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.