miércoles, 31 de enero de 2018

Prezcobix Label Revised

U.S. Food and Drug Administration Header

The PREZCOBIX (darunavir/cobicistat) label was recently revised:
  • To update the DRUG INTERACTIONS Section (subsection 7.3, Table 2) with the following:
    • Addition of prednisone as an alternative corticosteroid to consider for co-administration with PREZCOBIX, particularly for long term use
    • Dosage recommendations for HMG-Co A reductase inhibitors (atorvastatin and rosuvastatin) as follows:
      • atorvastatin dosage should not exceed 20 mg/day
      • rosuvastatin dosage should not exceed 20 mg/day
    • Addition of the following clinical comment regarding coadministration of PREZCOBIX and hormonal contraceptives, drospirenone and ethinyl estradiol
      • For co-administration with drospirenone, clinical monitoring is recommended due to the potential for hyperkalemia
    • Information regarding co-administration with the platelet aggregation inhibitor ticagrelor, specifically, coadministration of PREZCOBIX and ticagrelor is not recommended
  • To update the DRUG INTERACTIONS subsection 7.4 Drugs without Clinically Significant Interactions with PREZCOBIX as follows:
    • Clinically relevant drug-drug interactions have not been observed or are not anticipated with concomitant use of darunavir and cobicistat with rilpivirine, dolutegravir, raltegravir, abacavir, emtricitabine, emtricitabine/tenofovir alafenamide, tenofovir DF, lamivudine, stavudine, zidovudine, or acid modifying medications (antacids, H2-receptor antagonists, proton pump inhibitors).
The updated label will soon be available at drugs@fda or DailyMed
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
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