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U.S. Department of Health and Human Services

Safety

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Visudyne (verteporfin) for injection

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

 

Summary View

 

PRECAUTIONS

Nursing Mothers
  • The verteporfin breast milk levels were up to 66% of the corresponding plasma levels and declined below the limit of quantification (2 ng/mL) within 24 hours.
 

ADVERSE REACTIONS

Ocular Treatment Site
  • retinal pigment epithelial tear