Label Changes for:

Ziagen (abacavir sulfate) Tablets and Oral Solution

November 2011

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) – November 2011

  • Combivir (lamivudine/zidovudine) tablets
  • Emtriva (emtricitabine) Capsules and Oral Solution
  • Epivir(lamivudine) Tablets and Oral Solution
  • Epzicom (abacavir sulfate and lamivudine) Tablets
  • Retrovir  (zidovudine) IV Infusion, Capsules, Tablets, and Syrup
  • Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets
  • Videx (didanosine) Pediatric Powder Oral Solution
  • Videx EC (didanosine, USP) Capsules
  • Viread (tenofovir disoproxil fumarate) Tablets
  • Zerit (stavudine) Capsules and Oral Solution
  • Ziagen (abacavir sulfate) Tablets and Oral Solution

 

WARNINGS AND PRECAUTIONS

Immune Reconstitution Syndrome
  • 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 initiationof treatment.

 

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