Vectibix (panitumumab) Injection for Intravenous Use

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

Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS Dermatologic Toxicity ADVERSE REACTIONS Initial Section Pulmonary Embolism CLINICAL TRIALS EXPERIENCE Table 1 Metabolic/Nutritional Immunogenicity USE IN SPECIFIC POPULATIONS Pregnancy Nursing Mothers Pediatric Use PATIENT COUNSELING INFORMATION Advise patients to contact a healthcare professional for any of the following... (see highlighted section for changes) Advise patients of the need for... (see highlighted section for changes)

WARNINGS AND PRECAUTIONS ...Withhold Vectibix for severe or life-threatening dermatologic toxicity...