Label Changes for:
Invirase (saquinavir mesylate) Capsules and Tablets
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)
- 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
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 initiation of treatment.