FDA: Drug Interactions Section Updated for Prezcobix

Prescription bottle
Prescription bottle
The FDA has updated labeling for Prezcobix with new drug interactions data.

The labeling for Prezcobix (darunavir/cobicistat; Janssen) has been updated with new drug interactions data. 

Prezcobix, a combination of an HIV-1 protease inhibitor and a CYP3A inhibitor, is indicated to treat HIV-1 infection in adults. 

Under the Drug Interactions section, the following updates have been made:

  • Prednisone has been added as an alternative corticosteroid to consider for co-administration with Prezcobix especially for long-term use
  • Dose recommendations for HMG-CoA reductase inhibitors: daily doses for atorvastatin and rosuvastatin should not exceed 20mg. 
  • When coadministering Prezcobix with drospirenone (hormonal contraceptive), clinical monitoring is recommended due to potential for hyperkalemia.
  • Concomitant administration with ticagrelor, a platelet aggregation inhibitor, is not recommended. 

In addition, clinically relevant interactions have not been observed or are not anticipated with concomitant use of rilpivirine, dolutegravir, raltegravir, abacavir, emtricitabine, emtricitabine/tenofovir alafenamide, tenofovir DF, lamivudine, stavudine, zidovudine, or acid modifying medications (eg, antacids, H2-receptor antagonists, proton pump inhibitors).

Prezcobix is available as 800mg/150mg strength tablets in 30-count bottles.

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Prezcobix® [package insert]. Beerse, Belgium: Janseen; 2016.

This article originally appeared on MPR