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Detailed View: Trasylol Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- December 2006

Detailed View: Trasylol Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) — December 2006

Trasylol (aprotinin injection)

Prescribing Information

See MedWatch Safety Alert posted 12/15/2006.

BOXED WARNING (new)

CONTRAINDICATIONS

WARNINGS

• Anaphylactic or Anaphylactoid Reactions
• Re-exposure to Aprotinin
• Renal Dysfunction

PRECAUTIONS

• General
  

  * Initial (Test) Dose

  * Renal Dysfunction

ADVERSE REACTIONS

• Myocardial Infarction
  

  * Table: Incidence of Myocardial Infarctions
  by Treatment Group Population

• Laboratory Findings
  

  * Serum Creatinine

  * Serum Transaminases

BOXED WARNING

Trasylol 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) dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior aprotinin exposure and a history of any prior aprotinin exposure must be sought prior to Trasylol administration. The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent prior aprotinin exposure…..

CONTRAINDICATIONS

Administration of Trasylol to patients with a known or suspected previous aprotinin exposure during the last 12 months is contraindicated. For patients with known or suspected history of exposure to aprotinin greater than 12 months previously, see WARNINGS. Aprotinin may also be a component of some fibrin sealant products and the use of these products should be included in the patient history.

WARNINGS

See highlighted WARNINGS section of prescribing information for revisions.