FDA Approves New Labeling Updates for Prezcobix

opioid epidemic
opioid epidemic
The Food and Drug Administration has approved labeling updates for Prezcobix tablets for HIV.

The Food and Drug Administration (FDA) has approved labeling updates for Prezcobix (darunavir/cobicistat; Janssen) tablets.

Under Drug Interactions, new data on coadministration with MATE1 transporters and systemic/inhaled nasal/ophthalmic corticosteroids (eg, betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, prednisone, triamcinolone) have been added. Coadministration of Prezcobix with substrates of MATE1 transporters may increase plasma concentrations of such drugs, which may prolong or increase their therapeutic effect, and can be associated with adverse events.

Concomitant systemic dexamethasone or other corticosteroids that induce CYP3A activity may reduce the therapeutic effect of Prezcobix, and may result in development of resistance. Coadministration with corticosteroids potentiated by strong CYP3A inhibitors may increase the risk for Cushing’s syndrome and adrenal suppression. 

The label recommends considering alternative corticosteroids (eg, beclomethasone and prednisolone) for which the pharmacokinetics and pharmacodynamics are less affected by strong CYP3A inhibitors, especially for long term use.

Under Clinical Pharmacology, the sub-section on Darunavir Cardiac Electrophysiology has been abridged, and the sub-section on DrugInteractions has been updated to reflect new MATE1 transporter information.

Prezcobix, a protease inhibitor and CYP3A inhibitor combination, is indicated for the treatment of HIV-1 in adults with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M T74P, L76V, I84V, L89V), in combination with other antiretroviral agents. It is available as fixed-dose darunavir 800mg/cobicistat 150mg tablets.

Related Articles


PREZCOBIX® [package insert]. Titusville, NJ: Janssen Therapeutics; 2017.

This article originally appeared on MPR