Pregnancy: There are no adequate and well-controlled studies on pregnancy outcome with darunavir in pregnant women. Studies in animals have not shown evidence of developmental toxicity or effect on reproductive function and fertility (see Pharmacology: Toxicology under Actions).
To monitor maternal-fetal outcomes of pregnant women, an Antiretroviral Pregnancy Registry has been established (http://www.apregistry.com). This is a voluntary prospective, exposure-registration, observational study designed to collect and evaluate data on the outcomes of pregnancy exposures to antiretroviral products. For darunavir, sufficient first trimester exposures are available to allow detection of at least a two-fold increase in risk of overall birth defects. No such increases have been detected to date.
Darunavir/ritonavir (600/100 mg twice daily. or 800/100 mg once daily) in combination with a background regimen was evaluated in a clinical trial of 36 pregnant women during the second and third trimesters, and postpartum. The pharmacokinetic data demonstrate that exposure to darunavir and ritonavir as part of an antiretroviral regimen was lower during pregnancy compared with postpartum (6-12 weeks). Virologic response was preserved throughout the study period in both arms. No mother to child transmission occurred in the infants born to the 31 subjects who stayed on the antiretroviral treatment through delivery. Darunavir/ritonavir was well tolerated during pregnancy and postpartum. There were no new clinically relevant safety findings compared with the known safety profile of darunavir/ritonavir in HIV-1 infected adults (see Pharmacology: Pharmacokinetics: Special Populations - Pregnancy and Postpartum under Actions).
PREZISTA/ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk.
Breast-feeding: It is not known whether darunavir is excreted in human milk. Studies in rats have demonstrated that darunavir is excreted in milk. Because of both the potential for HIV transmission and the potential for serious adverse events in nursing infants, mothers should be instructed not to breastfeed if they are receiving PREZISTA.
Fertility: There was no effect on mating or fertility with PREZISTA treatment in rats (see Pharmacology: Toxicology under Actions).