Nurtec ODT Use In Pregnancy & Lactation

Pregnancy: There are limited data from the use of rimegepant in pregnant women. Animal studies demonstrate that rimegepant is not embryocidal, and no teratogenic potential has been observed at clinically relevant exposures. Adverse effects on embryo-foetal development (decreased foetal body weight and increased skeletal variations in rats) were only observed at exposure levels associated with maternal toxicity (approximately 200 times greater than clinical exposures) following administration of rimegepant during pregnancy (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). As a precautionary measure, it is preferable to avoid the use of NURTEC ODT during pregnancy.
Breast-feeding: In a single center study of 12 breast-feeding women treated with a single dose of rimegepant 75 mg, minimal concentrations of rimegepant were observed in breast milk. The relative percentage of a maternal dose estimated to reach the infant is less than 1%. There are no data on the effects on milk production. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for NURTEC ODT 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).