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U.S. Department of Health and Human Services

Safety

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Fuzeon (Enfuvirtide) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Immune Reconstitution Syndrome
  • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Fuzeon…
  • Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment.
 

PATIENT COUNSELING INFORMATION

  • Patients should be advised to avoid doing things that can spread HIV-1 infection to others…
 

PATIENT INFORMATION

General information about Fuzeon
  • Fuzeon does not cure HIV infection or AIDS...
  • Avoid doing things that can spread HIV-1 infection….
 
Who should not use Fuzeon? Tell your healthcare provider
  • Do not breastfeed.We do not know if Fuzeon can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.