Symtuza Use In Pregnancy & Lactation

Pregnancy: There are no adequate and well controlled trials with darunavir, cobicistat, emtricitabine, or tenofovir alafenamide, alone or in combination, in pregnant women. Studies in animals do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Treatment with darunavir/cobicistat (two of the components of Symtuza) during pregnancy results in low darunavir exposure (see Pharmacology: Pharmacokinetics under Actions), which may be associated with an increased risk of treatment failure and an increased risk of HIV transmission to the child. Therefore, therapy with Symtuza should not be initiated during pregnancy, and women who become pregnant during therapy with Symtuza should be switched to an alternative regimen (see Dosage & Administration and Precautions).
Breast-feeding: Emtricitabine is excreted in human milk. It is not known whether darunavir, cobicistat, or tenofovir alafenamide are excreted in human milk. Studies in animals have demonstrated that darunavir, cobicistat and tenofovir are excreted in milk.
Because of both the potential for HIV transmission and the potential for adverse reactions in breast-fed infants, mothers should be instructed not to breast-feed if they are receiving Symtuza.
Fertility: No human data on the effect of darunavir, cobicistat, emtricitabine, or tenofovir alafenamide on fertility are available. There was no effect on mating or fertility in animals (see Pharmacology: Toxicology: Preclinical safety data under Actions). Based on animal studies, no effect on reproduction or fertility is expected with Symtuza.