Pregnancy: There are no adequate and well controlled studies on the use of Pasurta in pregnant women. In a cynomolgus monkey reproduction study, there were no effects on pregnancy, embryo-fetal or post-natal development (up to six months of age) when erenumab was dosed throughout pregnancy at exposure levels 40 or 17-fold higher than those achieved in patients receiving erenumab at the 70 or 140 mg once monthly dosing regimen, respectively based on area under the concentration curve (AUC). Measurable erenumab serum concentrations were observed in the infant monkeys at birth, confirming that erenumab, like other IgG antibodies, crosses the placental barrier.
Animal studies are not always predictive of human response and therefore, it is not known whether Pasurta can cause fetal harm when administered to a pregnant woman. Pasurta should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether Pasurta is present in human milk. There are no data on the effects of Pasurta on the breastfed child or the effects of Pasurta on milk production. Because drugs are excreted in human milk and because of the potential for adverse effects in nursing infants from Pasurta, a decision should be made whether to discontinue nursing or discontinue Pasurta, taking into account the potential benefit of Pasurta to the mother and the potential benefit of breast feeding to the infant.
Fertility: No data are available on the effect of Pasurta on human fertility. There were no adverse effects on surrogate markers of fertility (anatomic pathology or histopathology changes in reproductive organs) in sexually mature monkeys at systemic exposures up to 283 or 123-fold higher than the clinical dose of 70 or 140 mg once monthly, respectively based on serum AUC (see Pharmacology: Toxicology: Non-Clinical Safety Data under ACTIONS).