Updates were made to the Perinatal Guideline on January 22, 2013, January 29, 2013 and April 3, 2013. For an explanation of the updates, please see the correction notice.
(Last updated:7/31/2012; last reviewed:7/31/2012)
Rilpivirine (Edurant, RPV)is classified as FDA Pregnancy Category B.
Animal carcinogenicity studies
Rilpivirine was neither mutagenic nor clastogenic in a series of in vitro and animal in vivo screening tests. Rilpivirine was not carcinogenic in rats when administered at doses 3 times higher than exposure in humans at the recommended dose of 25 mg once daily. Hepatocellular neoplasms were observed in both male and female mice at doses 21 times that of human therapeutic exposure; the observed hepatocellular findings in mice may be rodent specific.1
No effect on fertility was observed when rilpivirine was tested in rats at maternal doses up to 400 mg/kg/day, resulting in systemic drug exposure equivalent to 40 times the recommended human dose.
No evidence of embryonic or fetal toxicity or an effect on reproductive function was observed in rat and rabbit dams treated with rilpivirine during pregnancy and lactation at doses 15 and 70 times higher, respectively, than exposure in humans at the recommended dose of 25 mg once daily.
Placental and breast milk passage
No data exist on whether rilpivirine crosses the placenta or is excreted in breast milk in humans. Studies in lactating rats and their offspring indicate that rilpivirine is present in rat milk.
Human studies in pregnancy
No adequate and well-controlled studies of rilpivirine use in pregnant women have been conducted.