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Bictegravir

Brand names: BIKTARVY (in combination)

Interactions

Active ingredient Bictegravir interacts in the following cases:

Inhibitors of P-gp and/or BCRP

Bictegravir is both a P-gp and a BCRP substrate. The clinical relevance of this feature is not established. Therefore, caution is recommended when bictegravir is combined with medicinal products known to inhibit P-gp and/or BCRP (e.g. macrolides, ciclosporin, verapamil, dronedarone, glecaprevir/pibrentasvir).

Pregnancy

There are no or limited data (less than 300 pregnancy outcomes) from the use of bictegravir in pregnant women.

Studies of bictegravir in animals have shown no evidence of harmful effects on fertility parameters, pregnancy, or foetal development.
Bictegravir should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Nursing Mothers

It is not known whether bictegravir 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.

There is insufficient information on the effects in newborns/infants, therefore bictegravir should not be used during breast-feeding.

Carcinogenesis, Mutagenesis and Fertility

Fertility

No human data on the effect of bictegravir on fertility are available. Animal studies indicate no effects of bictegravir on mating or fertility.