Following the Dear Healthcare Professional communication in July 2010 regarding the association of saquinavir (Invirase) with arrhythmogenic risk due to prolongation of the QT and PR intervals, the European Medicines Agency have reviewed the consolidated pharmacokinetic and safety data for saquinavir. It is now recommended that for treatment-naive patients initiating treatment with saquinavir/ritonavir, the starting dose of saquinavir is 500 mg (1 x 500 mg film-coated tablet) two times daily with ritonavir 100mg two times daily in combination with other antiretroviral agents for the first 7 days of treatment. After 7 days, the recommended dose of saquinavir is 1000 mg two times daily with ritonavir 100mg two times daily in combination with other antiretroviral agents.
The latest Summary of Product Characteristics for Invirase 500 mg film-coated tablets can be accessed through the electronic medicines compendium website:
Notification of the revised recommendation for the starting dose of Invirase 500 mg film-coated tablets in treatment-naive patients.
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