GENVOYA(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)tablets(十)
rease of TAF concentrations is not expected upon coadministration of an additional P-gp and/or BCRP inhibitor. Drugs that induce P-gp activity are expected to decrease the absorption of TAF, resulting in decreased plasma concentration of TAF.
7.4 Drugs Affecting Renal Function
Because emtricitabine and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion, coadministration of GENVOYA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine, tenofovir, and other renally eliminated drugs and this may increase the risk of adverse reactions. Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see WARNINGS AND PRECAUTIONS (5.4)].
7.5 Established and Other Potentially Significant Interactions
Table 5 provides a listing of established or potentially clinically significant drug interactions. The drug interactions described are based on studies conducted with either GENVOYA, the components of GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as individual agents and/or in combination, or are predicted drug interactions that may occur with GENVOYA [for magnitude of interaction, see CLINICAL PHARMACOLOGY (12.3)]. The table includes potentially significant interactions but is not all inclusive.
Table 5Established and Other Potentially Significant* Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction
Concomitant Drug Class: Drug Name Effect on Concentration† Clinical Comment
* This table is not all inclusive. † ↑ = Increase, ↓ = Decrease, ↔ = No Effect ‡ Indicates that a drug-drug interaction trial was conducted.
Acid Reducing Agents:
antacids‡
e.g.,
aluminum and magnesium hydroxide ↓ elvitegravir Separate GENVOYA and antacid administration by at least 2 hours.
Antiarrhythmics:
e.g.,
amiodarone
bepridil
digoxin‡
disopyramide
flecainide
systemic lidocaine mexiletine
propafenone
quinidine ↑ antiarrhythmics
↑ digoxin Caution is warranted and therapeutic concentration monitoring, if available, is recommended for antiarrhythmics when coadministered with GENVOYA.
Antibacterials:
clarithromycin
telithromycin ↑ clarithromycin
↑ telithromycin
↑ cobicistat Patients with CLcr greater than or equal to 60 mL/minute:
No dosage adjustment of clarithromycin is required.
Patients with CLcr between 50 mL/minute and 60 mL/minute:
The dosage of clarithromycin should be reduced by 50%.
Anticoagulants:
warfarin Effect on warfarin unknown Monitor the international normalized ratio (INR) upon coadministration with GENVOYA.
Anticonvulsants:
ethosuximide
oxcarbazepine ↑ ethosuximide
↓ elvitegravir
↓ cobicistat
↓ TAF For contraindicated anticonvulsants, [see CONTRAINDICATIONS (4)]
Alternative anticonvulsants should be considered when GENVOYA is administered with oxcarbazepine.
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