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Label Changes for:

Photofrin (porfimer sodium) for injection

June 2011

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2011

 

WARNINGS AND PRECAUTIONS

Edits to various subsection plus new subsection

Thromboembolism
  • Thromboembolic events can occur following photodynamic therapy with Photofrin. Most reported events occurred in patients with other risk factors for thromboembolism including advanced cancer, following major surgery, prolonged immobilization, or cardiovascular disease.

 

ADVERSE REACTIONS

Postmarketing Experience
  • The following adverse reactions have been identified during post-approval use of Photofrin with PDT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Infusion reactions: Infusion reactions including urticaria, bradycardia, hypotension, dizziness, and hypertension
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