Edurant Use In Pregnancy & Lactation

Pregnant Women: No well-controlled clinical or pharmacokinetic studies of EDURANT use in pregnant women have been conducted. Studies in animals have shown no evidence of relevant embryonic or fetal toxicity or an effect on reproductive function (see Pharmacology: Toxicology: Non-Clinical Toxicology: Reproductive and Developmental Toxicity under Actions).
There was no teratogenicity with rilpivirine in rats and rabbits. The exposures at the embryo-fetal No Observed Adverse Effects Levels (NOAELs) in rats and rabbits were respectively 15 and 70 times higher than the exposure in humans at the recommended dose of 25 mg once daily (see Pharmacology: Toxicology: Non-Clinical Toxicology: Reproductive and Developmental Toxicity under Actions). EDURANT should not be used during pregnancy unless the potential benefits outweigh the potential risks.
Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 pregnant women during the second and third trimesters, and postpartum. The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks). Virologic response was preserved throughout the trial period. No mother to child transmission occurred in all 10 infants born to the mothers who completed the trial and for whom the HIV status was available. Rilpivirine was well tolerated during pregnancy and postpartum. There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults. (See Pharmacology: Pharmacokinetics: Special Populations and Conditions: Pregnancy and Breast-feeding: Pregnancy and Postpartum under Actions.)
Breast-feeding: It is not known whether rilpivirine is secreted in human milk. Because of both the potential for HIV transmission and the potential for adverse reactions in nursing infants, mothers should be instructed not to breast-feed if they are receiving EDURANT (see Pharmacology: Toxicology: Non-Clinical Toxicology: Reproductive and Developmental Toxicity under Actions).