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Label Changes for:

Invirase (saquinavir mesylate) Capsules and Tablets

February 2012

Changes have been made to the WARNINGS, PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2010 and February 2012


February 2012



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 initiation of treatment.