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
 
Visit the FDA Patient Network for more Information about the HIV Liaison Program 

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