Label Changes for:
Photofrin (porfimer sodium) Injection
September 2008
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) -- September 2008
| The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. |
| Sections Modified |
Summary of Changes to Contraindications and Warnings |
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WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
NONCLINICAL TOXICOLOGY
PATIENT COUNSELING INFORMATION
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WARNINGS AND PRECAUTIONS High-Grade Dysplasia (HGD) in Barrett’s Esophagus (BE) ...The follow-up period of the randomized study at the time of analysis was a minimum of two years (ranging from 2 to 5.6 years). Photosensitivity Conventional ultraviolet (UV) sunscreens will only protect against UV light-related photosensitivity and will be of no value in protecting against induced photosensitivity reactions caused by visible light. Esophageal Strictures See Table 5, located after Section 5.10. Table 5: Esophageal Dilations in Patients with Treatment-Related Strictures The “Number of Patients with Strictures” has changed from 122 to 114. The number of patients and percentage in each row has also changed. Hepatic and Renal Impairment Hepatic or Renal impairment will likely prolong the elimination of porfimer sodium leading to higher rates of toxicity. Patients with severe renal impairment or mild to severe hepatic impairment should be clearly informed that the period requiring the precautionary measures for photosensitivity may be longer than 90 days. |
