Label Changes for:
Photofrin (porfimer sodium) for injection
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
- 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.
- 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