Mega PTH Use In Pregnancy & Lactation

Use in Pregnancy: Pregnancy Category C: Reported studies in rabbits have shown reproductive toxicity. The potential risk for humans is unknown. Given the indication, Teriparatide should not be used during pregnancy.
In pregnant rats given subcutaneous teriparatide doses up to 1000 mcg/kg/day, there were no mortality. In pregnant mice given subcutaneous doses of 225 or 1000 mcg/kg/day (≥60 times the human dose based on surface area, mcg/m²) from gestation Day 6 through 15, the fetuses showed an increased incidence of skeletal deviations or variations (interrupted rib, extra vertebra or rib). Developmental effects in a perinatal/postnatal study in pregnant rats given subcutaneous doses of teriparatide from gestation day 6 through postpartum Day 20 included mild growth retardation in female offspring at doses ≥225 mcg/kg/day (≥120 times the human dose based on surface area, mcg/m²), and in male offspring at 1000 mcg/kg/day (540 times the human dose based on surface area, mcg/m²). There was also reduced motor activity in both male and female offspring at 1000 mcg/kg/day. There were no developmental or reproductive effects in mice or rats at a dose of 30 mcg/kg (8 or 16 times the dose based on surface area, mcg/m²). The effect of teriparatide treatment on human fetal development has not been studied. Teriparatide (rDNA origin) is not indicated for use in pregnancy.
Use in Lactation: Because Teriparatide (rDNA origin) is indicated for the treatment of osteoporosis in postmenopausal women, it should not be administered to women who are nursing their children. There have been no clinical studies to determine if teriparatide is secreted into breast milk.