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