Label Changes for:

Campath (alemtuzumab) Injection for intravenous use

May 2009

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) -- May 2009

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.

WARNINGS AND PRECAUTIONS

Immunosuppression/Infections

  • The following sentence was rewritten: "Administer only irradiated blood products to avoid transfusion associated Graft versus Host Disease (TAGVHD), unless emergent circumstances dictate immediate transfusion."

ADVERSE REACTIONS

Postmarketing Experience

  • Cardiovascular: congestive heart failure...
  • Immune disorders: ...fatal transfusion associated Graft versus Host Disease
  • Infections: ...including EBV-associated lymphoproliferative disorder...re-activation of latent viruses.

    

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