(Last updated: March 28, 2014; last reviewed: March 28, 2014)
Dolutegravir is classified as Food and Drug Administration Pregnancy Category B.
Animal Carcinogenicity Studies
Dolutegravir was not genotoxic or mutagenic in vitro. No carcinogenicity was detected in 2-year long-term studies in mice at exposures up to 14-fold higher than that achieved with human systemic exposure at the recommended dose, or in rats at exposures up to 10-fold higher in males and 15-fold higher in females than human exposure at the recommended dose.
Reproduction/Fertility Animal Studies
Dolutegravir did not affect fertility in male and female rats and rabbits at exposures approximately 27-fold higher than human clinical exposure, based on area under the curve, at the recommended dose.
Teratogenicity/Developmental Toxicity Animal Studies
Studies in rats and rabbits have shown no evidence of developmental toxicity, teratogenicity or effect on reproductive function with dolutegravir.
Placental and Breast Milk Passage
Studies in rats have demonstrated that dolutegravir crosses the placenta in animal studies and is excreted into breast milk in rats. No human data on placental passage or breast milk excretion are available.
Human Studies in Pregnancy
No studies of dolutegravir use in human pregnancy have been reported.How to Cite the Guidelines