GENVOYA(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)tablets(二十二)
ears of age [see USE IN SPECIFIC POPULATIONS (8.5)].
Race
Based on population pharmacokinetic analyses, no dosage adjustment is recommended based on race.
Gender
Based on population pharmacokinetic analyses, no dosage adjustment is recommended based on gender.
Drug Interaction Studies
[see also CONTRAINDICATIONS (4) and DRUG INTERACTIONS (7)]
The drug-drug interaction studies described in Tables 9–11 were conducted with GENVOYA, elvitegravir (coadministered with cobicistat or ritonavir), cobicistat administered alone, or TAF (administered alone or coadministered with emtricitabine).
As GENVOYA should not be administered with other antiretroviral medications, information regarding drug-drug interactions with other antiretrovirals agents is not provided.
The effects of coadministered drugs on the exposure of elvitegravir are shown in Table 9. The effects of coadministered drugs on the exposure of TAF are shown in Table 10. The effects of GENVOYA or its components on the exposure of coadministered drugs are shown in Table 11. For information regarding clinical recommendations, see DRUG INTERACTIONS (7).
Table 9 Drug Interactions: Changes in Pharmacokinetic Parameters for Elvitegravir in the Presence of the Coadministered Drug*
Coadministered Drug Dose of Coadministered Drug (mg) Elvitegravir Dose (mg) CYP3A Inhibitor Cobicistat or Ritonavir Dose (mg) N Mean Ratio of Elvitegravir Pharmacokinetic
Parameters (90% CI); No effect = 1.00
Cmax AUC Cmin
* All interaction studies conducted in healthy volunteers. † Study conducted with GENVOYA.
Antacids 20 mL single dose given 4 hours before elvitegravir 50 single dose Ritonavir
100 single dose 8 0.95
(0.84,1.07) 0.96
(0.88,1.04) 1.04
(0.93,1.17)
20 mL single dose given 4 hours after elvitegravir 10 0.98
(0.88,1.10) 0.98
(0.91,1.06) 1.00
(0.90,1.11)
20 mL single dose given 2 hours before elvitegravir 11 0.82
(0.74,0.91) 0.85
(0.79,0.91) 0.90
(0.82,0.99)
20 mL single dose given 2 hours after elvitegravir 10 0.79
(0.71,0.88) 0.80
(0.75,0.86) 0.80
(0.73,0.89)
Carbamazepine 200 twice daily 150 once daily Cobicistat
150 once daily 12 0.55
(0.49,0.61) 0.31
(0.28,0.33) 0.03
(0.02,0.40)
Famotidine 40 once daily given 12 hours after elvitegravir 150 once daily Cobicistat
150 once daily 10 1.02
(0.89,1.17) 1.03
(0.95,1.13) 1.18
(1.05,1.32)
40 once daily given simultaneously with elvitegravir 16 1.00
(0.92,1.10) 1.03
(0.98,1.08) 1.07
(0.98,1.17)
Ketoconazole 200 twice daily 150 once daily Ritonavir
100 once daily 18 1.17
(1.04,1.33) 1.48
(1.36,1.62) 1.67
(1.48,1.88)
Ledipasvir/ Sofosbuvir 90/400 once daily 150 once daily† Cobicistat
150 once daily† 30 0.98
(0.90,1.07) 1.11
(1.02,1.20) 1.46
(1.28,1.66)
Omeprazole 40 once daily given 2 hours before elvitegravir 50 once daily
Ritonavir
100 once daily 9 0.93
(0.83,1.04) 0.99
(0.91,1.07) 0. |
