Darunavir and cobicistat and Mitapivat interaction

Strong CYP3A Inhibitors and Inducers: Avoid concomitant use.

Moderate CYP3A Inhibitors: Avoid concomitant use.

Prevention or Management Avoid co-administration of strong CYP3A inhibitors with AQVESME [see Dosage and Administration (2.4) ] .

Prevention or Management Avoid co-administration of moderate CYP3A inhibitors with AQVESME [see Dosage and Administration (2.4) ] .

Effect of Other Drugs on AQVESME Strong CYP3A Inhibitors Clinical Impact Co-administration of AQVESME with strong CYP3A inhibitors increased mitapivat plasma concentrations [see Clinical Pharmacology (12.3) ] .

Co-administration of PREZCOBIX or PREZCOBIX PED with CYP3A inducers may lead to lower exposures of darunavir and cobicistat and potential loss of efficacy of darunavir and possible resistance.

Anticonvulsants with CYP3A induction effects that are NOT contraindicated: e.g. eslicarbazepine, oxcarbazepine ↓ cobicistat darunavir: effect unknown Consider alternative anticonvulsant or antiretroviral therapy to avoid potential changes in exposures.

Initiation of medications that inhibit or induce CYP3A may respectively increase or decrease concentrations of PREZCOBIX or PREZCOBIX PED.

Co-administration of PREZCOBIX or PREZCOBIX PED and drugs that induce CYP3A activity are expected to increase the clearance of darunavir and cobicistat, resulting in lowered plasma concentrations of darunavir and cobicistat which may lead to loss of therapeutic effect and development of resistance.

…metabolized by CYP3A: e.g. betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone ↓ darunavir ↓ cobicistat ↑ corticosteroids Co-administration with systemic dexamethasone or other systemic corticosteroids that induce CYP3A may result in loss of therapeutic effect and development of resistance to PREZCOBIX or PREZCOBIX PED.