Anaphylactic or Anaphylactoid Reactions

• Aprotinin administration may cause fatal anaphylactic or anaphylactoid reactions.
• Fatal reactions have occurred with an initial (test) dose as well as with any of the components of the dose regimen.
• Fatal reactions have also occurred in situations where the initial (test) was tolerated.
• The risk for anaphylactic or anaphylactioid reactions is increased among patients with prior aprotinin exposure. A history of any prior aprotinin exposure must be sought prior to administration of this agent.
• The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent prior aprotinin exposure.
• Aprotinin should be administered only in operative settings where cardiopulmonary bypass can be rapidly initiated.
• The benefit of aprotinin to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis associated with any subsequent exposure to aprotinin (SEE CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).