Label Changes for:

Humira (adalimumab) Injection, Solution For Subcutaneous Use

January 2008

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.


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

  • Malignancies

ADVERSE REACTIONS

  • Immunogenicity
  • Plaque Psoriasis Clinical Studies

PATIENT COUNSELING INFORMATION

  • Medication Guide

MEDICATION GUIDE (new)

WARNINGS AND PRECAUTIONS

See highlighted text for labeling revisions.

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