GENVOYA(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)tablets(四)
ning events. These drugs and other contraindicated drugs (which may lead to reduced efficacy of GENVOYA and possible resistance) are listed in Table 1 [see DRUG INTERACTIONS (7.5) and CLINICAL PHARMACOLOGY (12.3)].
Table 1 Drugs that are Contraindicated with GENVOYA
Drug Class Drugs within Class that are Contraindicated with GENVOYA Clinical Comment
* Indicates that a drug-drug interaction trial was conducted. † See DRUG INTERACTIONS (7), Table 5 for sildenafil when used for erectile dysfunction. ‡ See DRUG INTERACTIONS (7), Table 5 for parenterally administered midazolam.
Alpha 1-Adrenoreceptor Antagonist Alfuzosin Potential for increased alfuzosin concentrations, which can result in hypotension.
Anticonvulsants Carbamazepine*
Phenobarbital
Phenytoin Carbamazepine, phenobarbital, and phenytoin are potent inducers of CYP450 metabolism and may cause significant decrease in the plasma concentration of elvitegravir, cobicistat, and TAF. This may result in loss of therapeutic effect to GENVOYA.
Antimycobacterial Rifampin Rifampin is a potent inducer of CYP450 metabolism and may cause significant decrease in the plasma concentration of elvitegravir, cobicistat, and TAF. This may result in loss of therapeutic effect to GENVOYA.
Antipsychotics Lurasidone Potential for serious and/or life-threatening reactions.
Pimozide Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Ergot Derivatives Dihydroergotamine
Ergotamine
Methylergonovine Potential for serious and/or life-threatening events such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
GI Motility Agent Cisapride Potential for serious and/or life-threatening events such as cardiac arrhythmias.
Herbal Products St. John's wort (Hypericum perforatum) Coadministration of products containing St. John's wort and GENVOYA may result in reduced plasma concentrations of elvitegravir, cobicistat, and TAF. This may result in loss of therapeutic effect and development of resistance.
HMG-CoA Reductase Inhibitors Lovastatin
Simvastatin Potential for serious reactions such as myopathy, including rhabdomyolysis.
Phosphodiesterase-5 (PDE5) Inhibitor Sildenafil† when dosed as REVATIO for the treatment of pulmonary arterial hypertension There is increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, priapism, and syncope).
Sedative/hypnotics Triazolam
Orally administered midazolam‡ Triazolam and orally administered midazolam are extensively metabolized by CYP3A4. Coadministration of triazolam or orally administered midazolam with GENVOYA may cause large increases in the concentration of these benzodiazepines. The potential exists for serious and/or life threatening events such as prolonged or increased sedation or respiratory depression.CLOSE
5 WARNINGS AND PRECAUTIONS
5.1 Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV
Patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) before initiating antiretroviral therapy [see DOSAGE AND ADMINISTRATION (2.1)]. GENVOYA is not approved for |
