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.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • High-Grade Dysplasia (HGD) in Barrett’s Esophagus (BE)
  • Photosensitivity
  • Esophageal Strictures
    • Table 5: Esophageal Dilations in Patients with Treatment-Related Strictures
  • Hepatic and Renal Impairment (new subsection)

ADVERSE REACTIONS

  • Overall Adverse Reaction Profile
  • Adverse Reactions in Clinical Trials
    • High-Grade Dysplasia (HGD) in Barrett’s Esophagus (BE)

DRUG INTERACTIONS

  • Concomitant Therapy
    • Photodynamic therapy (PDT) with Photofrin causes direct intracellular damage...

USE IN SPECIFIC POPULATIONS

  • Pregnancy
  • Nursing Mothers

NONCLINICAL TOXICOLOGY

  • Carcinogenesis, Mutagenesis, and Impairment of Fertility

PATIENT COUNSELING INFORMATION

  • Photosensitivity (subsection added)
  • Common Adverse Reactions (subsection added)

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.

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