Revised SPC: Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide fumarate) film coated tablets

Updates to section 4.5 include a new note that in vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving tenofovir alafenamide with other medicinal products is low.

The full paragraph that has been added to section 4.5 of the SPC, under the tenofovir alafenamide subsection, is as follows:

 

“Based on data from an in vitro study, co-administration of tenofovir alafenamide and xanthine oxidase inhibitors (e.g., febuxostat) is not expected to increase systemic exposure to tenofovir in vivo. In vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving tenofovir alafenamide with other medicinal products is low. Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6. Tenofovir alafenamide is not an inhibitor of CYP3A4 in vivo. Tenofovir alafenamide is a substrate of OATP in vitro. Inhibitors of OATP and BCRP include ciclosporin.”