Aquipta Use In Pregnancy & Lactation

Pregnancy: Risk Summary: There are no adequate data on the developmental risk associated with the use of AQUIPTA in pregnant women. In animal studies, oral administration of atogepant during the period of organogenesis (rats and rabbits) or throughout pregnancy and lactation (rats) resulted in adverse developmental effects (decreased fetal and offspring body weight in rats; increased incidence of fetal structural variations in rabbits) at exposures greater than those used clinically. Atogepant is not recommended during pregnancy and in women of childbearing potential not using contraception.
Data (animal and/or human): Animal Data: Oral administration of atogepant (0, 5, 15, 125, or 750 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreased fetal body weight and an increased incidence of fetal variations at the two highest doses tested (125 and 750 mg/kg) which was associated with maternal toxicity. At the no-effect dose (15 mg/kg/day) for adverse effects on embryofetal development, plasma exposure (AUC) was approximately 4 times that in humans at the maximum recommended human dose (MRHD) of 60 mg/day.
Oral administration of atogepant (0, 30, 90, or 130 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in an increase in fetal visceral and skeletal variations at the highest dose tested (130 mg/kg/day), which was associated with minimal maternal toxicity. At the no-effect dose (90 mg/kg/day) for adverse effects on embryofetal development, plasma exposure (AUC) was approximately 3 times that in humans at the MRHD.
Oral administration of atogepant (0, 15, 45, or 125 mg/kg/day) to rats throughout gestation and lactation resulted in decreased pup body weight at the highest dose tested (125 mg/kg/day), which persisted into adulthood. At the no-effect dose (45 mg/kg/day) for adverse effects on pre- and postnatal development, plasma exposure (AUC) was approximately 5 times that in humans at the MRHD.
Lactation: In a study of 12 breast-feeding women administered a single oral dose of atogepant 60 mg, transfer of atogepant into breast milk was minimal. The relative infant dose was approximately 0.19% of the maternal weight-adjusted dose with a milk-to-plasma ratio of 0.08. The cumulative amount of atogepant excreted in breast milk over 24 hours was minimal, at less than 0.01 mg. There are no data on the effects of atogepant on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for AQUIPTA and any potential adverse effects on the breastfed infant from AQUIPTA or from the underlying maternal condition.