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Label Changes for:

Invirase (saquinavir mesylate) Capsules and Tablets

April 2015

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

April 2015

ADVERSE REACTIONS

Drug Integrations
  • Concomitant use of fusidic acid and saquinavir/ritonaviris not recommended due to potential for increased mutual toxicities.The interaction between INVIRASE/ritonavir and fusidic acid has not been formally evaluated. Co-administration of fusidic acid and INVIRASE/ritonavir can cause increased plasma concentrations of fusidic acid, saquinavir and ritonavir

 

February 2012

WARNINGS AND PRECAUTIONS

Immune Reconstitution Syndrome
  • Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-BarrĂ© 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.
 
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