Evenity Use In Pregnancy & Lactation

Effects on fertility: No data are available on the effect of romosozumab (EVENITY) on human fertility. Animal studies in female and male rats did not show any effects on fertility at subcutaneous doses up to 300 mg/kg/week yielding 54 times the systemic exposure [serum AUC] in patients at the maximum recommended human dose of 210 mg monthly.
Use in pregnancy: Pregnancy Category: B3.
There are no studies of romosozumab (EVENITY) in pregnant women. Therefore, it is not known whether romosozumab (EVENITY) can cause fetal harm when administered to a pregnant woman.
Reproductive and developmental effects of romosozumab were assessed in the rat in a preliminary and definitive embryo-fetal development study, a combined fertility and embryo-development study, and a pre- and post-natal study. Skeletal malformations, including syndactyly and polydactyly, were observed in fetuses of rats given subcutaneous doses of romosozumab at 300 mg/kg/week during gestation. This occurred at a very high multiple of the clinical systemic exposure (with serum AUC in animals at this dose predicted to be at least 30 times higher than in patients at the maximum recommended dose) and at low incidence (1/75 litters across all studies), but the findings exceeded the upper historical control range. A relationship to treatment cannot be excluded. No adverse effects on embryofetal development were observed with romosozumab in rats at 100 mg/kg/week (estimated to yield 16 times the systemic exposure in patients). Placental transfer of romosozumab was shown in rats and, as an IgG, is expected in humans, increasing as pregnancy progresses. There were no adverse effects on post-natal growth and development.
Syndactyly occurs at a high incidence in sclerosteosis but does not occur in patients heterozygous for the genetic mutation. The risk of malformations following romosozumab exposure is expected to be low based on animal data and considering the timing of digit formation in the first trimester in humans, when placental transfer of immunoglobulins is limited.
Use in lactation: It is not known whether romosozumab (EVENITY) is present in human milk. Because many drugs are excreted in human milk and because of the potential for adverse effects in nursing infants from romosozumab (EVENITY), a decision should be made whether to discontinue nursing or discontinue romosozumab (EVENITY), taking into account the potential benefit of romosozumab (EVENITY) to the mother or the potential benefit of breastfeeding to the infant.