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Coadministration | SYMTUZA® (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) HCP


Coadministration With SYMTUZA®

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Darunavir and cobicistat are both inhibitors of the cytochrome P450 3A (CYP3A) isoform. SYMTUZA® should not be coadministered with medicinal products that are highly dependent on CYP3A for clearance and for which increased plasma concentrations are associated with serious and/or life-threatening events.

Darunavir and cobicistat are both substrates of the cytochrome P450 3A (CYP3A) isoform. Coadministration of SYMTUZA® with CYP3A inducers is expected to lower plasma concentrations of darunavir and cobicistat which may lead to loss of efficacy of darunavir and development of resistance.

These recommendations are based on drug interaction trials conducted with the components of SYMTUZA®, as individual agents or in combination, or are predicted interactions. No drug interaction trials have been performed with SYMTUZA® or with all the components administered together.

Examples of drugs that are contraindicated
Alpha 1-adrenoreceptor antagonist alfuzosin
Anticonvulsants carbamazepine, phenobarbital, phenytoin
Antigout colchicine in patients with renal and/or hepatic impairment
Antimycobacterial rifampin
Antipsychotics lurasidone, pimozide
Cardiac disorders dronedarone, ivabradine, ranolazine
Ergot derivatives dihydroergotamine, ergotamine, methylergonovine
Hepatitis C direct-acting antivirals elbasvir/grazoprevir
Herbal product St. John’s wort (Hypericum perforatum)
Lipid-modifying agents lomitapide, lovastatin, simvastatin
Opioid antagonist naloxegol
PDE-5 inhibitor sildenafil when used for treatment of pulmonary arterial hypertension
Sedatives/hypnotics midazolam, triazolam
Examples of drugs where coadministration is not recommended
Anticoagulant rivaroxaban
Anticonvulsants eslicarbazepine, oxcarbazepine
Antifungal voriconazole
Antimycobacterials rifabutin, rifapentine
Corticosteroids betamethasone, budesonide, ciclesonide, dexamethasone (systemic), fluticasone, methylprednisolone, mometasone, triamcinolone
Hepatitis C direct-acting antivirals glecaprevir/pibrentasvir
Immunosuppressant/neoplastic everolimus, irinotecan
Inhaled beta agonist salmeterol
PDE-5 inhibitor avanafil
Platelet aggregation inhibitors clopidogrel, ticagrelor

The information presented here is a subset of clinical information in Table 4 of the Prescribing Information; it is not a complete list of all information in Table 4.

PDE-5=phosphodiesterase type 5.

Reference: SYMTUZA® [package insert]. Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP.