US darunavir label updated: drug interactions and pregnancy

Simon Collins, HIV i-Base

Recent updates to the full prescribing information for darunavir includes changes linked to drug interactions and use in pregnancy. [1, 2]

Table 11 include new information about anticonvulsants, antifungals, antipsychotics, narcotic analgesics metabolized by CYP3A, and platelet aggregation inhibitor as follows:

  • Clonazepam. Clinical monitoring of anticonvulsants that are metabolised by CYP3A is recommended
  • Perphenazine. A decrease in the dose of antipsychotics that are metabolised by CYP3A or CYP2D6 may be needed when co-administered with darunavir/ritonavir.
  • Narcotic analgesics metabolised by CYP3A: e.g. fentanyl, oxycodone. Careful monitoring of therapeutic effects and adverse reactions associated with CYP3A-metabolised narcotic analgesics (including potentially fatal respiratory depression) is recommended with co-administration.
  • Tramadol. A dose decrease may be needed for tramadol with concomitant use.
  • Platelet aggregation inhibitor ticagrelor. Co administration of darunavir/ritonavir and ticagrelor is not recommended.

The section on use in pregnancy includes a pharmacology study in 35 HIV positive pregnant women comparing once-daily and twice-daily dosing. Results included lower drug exposure during the third trimester, especially in the once-daily arm. All 29 infants with available results were HIV negative at delivery or 16 weeks postpartum.

Please see full prescribing information for full details.


  1. US FDA HIV email update. Darunavir (Prezista) label revised. (30 January 2018).
  2. US FDA HIV email update. Darunavir/cobicistat (Prezcobix) label revised. (30 January 2018).

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