GENVOYA(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)tablets(十三)
naloxone No dosage adjustment of buprenorphine/naloxone is required upon coadministration with GENVOYA. Patients should be closely monitored for sedation and cognitive effects.
Inhaled Beta Agonist:
salmeterol ↑ salmeterol Coadministration of salmeterol and GENVOYA is not recommended. Coadministration of salmeterol with GENVOYA may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.
Phosphodiesterase-5 (PDE5) Inhibitors:
sildenafil
tadalafil
vardenafil ↑ PDE5 inhibitors For contraindicated PDE-5 inhibitors, [see CONTRAINDICATIONS (4)]
Coadministration with GENVOYA may result in an increase in PDE-5 inhibitor associated adverse reactions, including hypotension, syncope, visual disturbances, and priapism.
Use of PDE-5 inhibitors for pulmonary arterial hypertension (PAH):
Use of sildenafil is contraindicated when used for the treatment of pulmonary arterial hypertension (PAH).
The following dose adjustments are recommended for the use of tadalafil with GENVOYA:
Coadministration of tadalafil in patients on GENVOYA:
In patients receiving GENVOYA for at least 1 week, start tadalafil at 20 mg once daily. Increase tadalafil dose to 40 mg once daily based upon individual tolerability.
Coadministration of GENVOYA in patients on tadalafil:
Avoid use of tadalafil during the initiation of
GENVOYA. Stop tadalafil at least 24 hours prior to starting GENVOYA. After at least one week following initiation of GENVOYA, resume tadalafil at 20 mg once daily. Increase tadalafil dose to 40 mg once daily based upon individual tolerability.
Use of PDE-5 inhibitors for erectile dysfunction:
Sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours, or tadalafil at a single dose not exceeding 10 mg in 72 hours can be used with increased monitoring for PDE-5 inhibitor associated with adverse events.
Sedative/hypnotics:
buspirone
zolpidem ↑ sedatives/hypnotics For contraindicated sedative/hypnotics, [see CONTRAINDICATIONS (4)]
With sedative/hypnotics, dose reduction may be necessary and clinical monitoring is recommended.
7.6 Drugs without Clinically Significant Interactions with GENVOYA
Based on drug interaction studies conducted with the components of GENVOYA, no clinically significant drug interactions have been either observed or are expected when GENVOYA is combined with the following drugs: entecavir, famciclovir, H2 receptor antagonists, ledipasvir, lorazepam, methadone, proton pump inhibitors, ribavirin, sertraline, sofosbuvir, and velpatasvir.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to GENVOYA during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
Risk Summary
Prospective pregnancy data from the Antiviral Pregnancy Registry (APR) are not sufficient to adequately assess the risk of birth defects of miscarriage. TAF use in women during pregnancy has not been eva luated; however, elvitegravir, cobicistat, and emtricitabine use during pregnancy has been eva luated in a limited number of women as reported to |
