ed when starting coadministration of bictegravir with metformin, due to the increased risk for lactic acidosis in these patients. A dose adjustment of metformin should be considered if required.
ORAL CONTRACEPTIVES
Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinylestradiol (0.025 mg once daily), Bictegravir1
Norelgestromin:
AUC:
Cmin:
Cmax:
Norgestrel:
AUC:
Cmin:
Cmax:
Ethinylestradiol:
AUC:
Cmin:
Cmax:
No dose adjustment is required upon co-administration.
Norgestimate (0.180/0.215/0.250 mg once daily), Ethinylestradiol (0.025 mg once daily), Emtricitabine/Tenofovir alafenamide4
SEDATIVES/HYPNOTICS
Midazolam (2 mg, oral syrup, single dose), Bictegravir/Emtricitabine/ Tenofovir alafenamide
Midazolam:
AUC:
Cmax:
No dose adjustment is required upon co-administration.
1 This study was conducted using bictegravir 75 mg single dose
2 This study was conducted using bictegravir/emtricitabine/tenofovir alafenamide 75/200/25 mg once daily
3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients
4 This study was conducted using emtricitabine/tenofovir alafenamide 200/25 mg once daily
5 Maximum strength antacid contained 80 mg aluminium hydroxide, 80 mg magnesium hydroxide, and 8 mg simethicone per mL
6 This study was conducted using elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150/150/200/10 mg once daily
Based on drug interaction studies conducted with Biktarvy or the components of Biktarvy, no clinically significant drug interactions are expected with: amlodipine, atorvastatin, buprenorphine, drospirenone, famciclovir, famotidine, fluticasone, naloxone, norbuprenorphin, omeprazole or rosuvastatin.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no or limited data (less than 300 pregnancy outcomes) from the use of bictegravir or tenofovir alafenamide in pregnant women. A large amount of data on pregnant women (more than 1,000 exposed outcomes) indicate no malformative nor foetal/neonatal toxicity associated with emtricitabine.
Animal studies do not indicate direct or indirect harmful effects of emtricitabine with respect to fertility parameters, pregnancy, foetal development, parturition or postnatal development. Studies of bictegravir and tenofovir alafenamide, administered separately, in animals have shown no evidence of harmful effects on fertility parameters, pregnancy, or foetal development (see section 5.3).
Biktarvy should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Breast-feeding
It is not known whether bictegravir or tenofovir alafenamide is excreted in human milk. Emtricitabine is excreted in human milk. In animal studies, bictegravir was detected in the plasma of nursing rat pups likely due to the presence of bictegravir in milk, without effects on nursing pups. In animal studies it has been shown that tenofovir is excreted in milk.
There is insufficient information on the effects of all the components of Biktarvy in newborns/infants, therefore Biktarvy should not be used during breast-feeding.
In order to avoid transmission of HIV to the infant it is recommended that HIV-infected women do not breast-feed their infants under any circumstances.
Fertility
No human data on the effect of Biktarvy on fertility are available. Animal studies indicate no effects of bicte |
