Nurtec Use In Pregnancy & Lactation

Pregnancy: There are no adequate human data on the developmental risk associated with the use of rimegepant in pregnancy. Animal studies demonstrate that at clinically relevant exposures rimegepant does not result in embryo-foetal death or foetal malformations. There were no developmental effects in rats at doses up to 60 mg/kg/day (exposures 46 times the human AUC at the maximum recommended human dose [MRHD] of 75 mg/day) or in rabbits at up to the highest dose tested of 50 mg/kg/day (exposures 10 times the MRHD of 75 mg/day). As a precautionary measure, it is preferable to avoid the use of NURTEC during pregnancy.
Lactation and breastfeeding: A lactation study was conducted in 12 healthy adult lactating women who were between 2 weeks and 6 months post-partum and were administered a single oral dose of rimegepant 75 mg. The results have established an average milk-to-plasma ratio of 0.20 and a relative infant dose of less than 1% of the maternal weight-adjusted dose. These data support that transfer of rimegepant into breast milk is low. There are no data on the effects of rimegepant on a breastfed infant or on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for NURTEC and any potential adverse reactions on the breastfed infant from rimegepant or from the underlying maternal condition.
Fertility: Animal studies showed no clinically relevant impact on female and male fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).