Pontevia Use In Pregnancy & Lactation

Pregnancy: Risk Summary: There are no adequate data on the developmental risk associated with the use of PONTEVIA in pregnant women. Administration of galcanezumab to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at plasma exposures greater than that expected clinically did not result in adverse effects on development (see Data: Animal Data as follows).
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively. The estimated rate of major birth defects (2.2% - 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.
Clinical Considerations: Disease-Associated Maternal and/or Embryo/Fetal Risk: Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.
Data: Animal Data: When galcanezumab was administered to female rats by subcutaneous injection in two studies (0, 30, or 100 mg/kg; 0 or 250 mg/kg) prior to and during mating and continuing throughout organogenesis, no adverse effects on embryofetal development were observed. The highest dose tested (250 mg/kg) was associated with a plasma exposure (C_{ave, ss}) 38 times that in humans at the recommended human dose (RHD) for migraine (120 mg).
Administration of galcanezumab (0, 30, or 100 mg/kg) by subcutaneous injection to pregnant rabbits throughout the period of organogenesis produced no adverse effects on embryofetal development. The higher dose tested was associated with a plasma C_{ave, ss} 64 times that in humans at 120 mg.
Administration of galcanezumab (0, 30, or 250 mg/kg) by subcutaneous injection to rats throughout pregnancy and lactation produced no adverse effects on pre- and postnatal development. The higher dose tested was associated with a plasma C_{ave, ss} 34 times that in humans at 120 mg.
Lactation: Risk Summary: There are no data on the presence of galcanezumab in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PONTEVIA and any potential adverse effects on the breastfed infant from PONTEVIA or from the underlying maternal condition.