Norvir, an HIV protease inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. The sNDAs proposed updates to the Contraindications, Warning and Precautions, Drug Interactions, and Patient Information sections.
The Contraindications section now includes the addition of dronedarone, an antiarrhythmic medication, and colchicine, an anti-gout medication. Concomitant dronedarone has the potential for cardiac arrhythmias; concomitant colchicine can lead to potentially serious and/or life-threatening reactions in patients with renal and/or hepatic impairment.
The Warnings and Precautions section has been updated with glucose monitoring information to state that monitoring for hyperglycemia, new onset diabetes mellitus, or an exacerbation of diabetes mellitus should be considered in patients treated with ritonavir.
The Drug Interactions section has been updated with colchicine and strong CYP3A inhibitor data for patients with renal and/or hepatic impairment. Concomitant administration with colchicine is contraindicated in patients with renal and/or hepatic impairment and specific dosing is listed for patients with normal renal or hepatic function.
In the Patient Information section, dronedarone and colchicine information has been listed under the “Who should not take Norvir?” explanation.
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