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.
