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Forteo ® (teriparatide injection)
20-mcg daily dose in a 2.4-mL prefilled delivery device
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Can pregnant or nursing women be treated with FORTEO® (teriparatide injection)?
Consider discontinuing teriparatide when pregnancy is recognized. Avoid teriparatide use in women who are breastfeeding.
Pregnancy During Teriparatide Treatment
There are no available data on teriparatide use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing teriparatide when pregnancy is recognized.1
Based on animal studies, use during pregnancy may cause fetal harm.1
Pregnant mice received teriparatide during organogenesis at subcutaneous doses 8 to 267 times the human dose. At doses ≥60 times the human dose, the fetuses showed an increased incidence of skeletal deviations or variations, such as interrupted rib, extra vertebra, or extra rib.1
When pregnant rats received teriparatide during organogenesis at subcutaneous doses 16 to 540 times the human dose, the fetuses showed no abnormal findings.1
Nursing During Teriparatide Treatment
It is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breastfed infant.1
Avoid teriparatide use in women who are breastfeeding.1
In a perinatal/postnatal study, pregnant rats received subcutaneous teriparatide from organogenesis through birth of the offspring and continued to receive teriparatide through lactation.1
Pregnant rats that were dosed subcutaneously from organogenesis through lactation experienced
- mild growth retardation in female offspring at doses ≥120 times the human dose
- mild growth retardation in male offspring at maternal doses 540 times the human dose, and
- reduced motor activity in both male and female offspring at maternal doses 540 times the human dose.1
There were no developmental or reproductive effects in mice or rats at doses 8 or 16 times the human dose, respectively.1
Pregnancy After Teriparatide Treatment
Pregnancy outcomes in humans have not been studied after a full course of teriparatide treatment. Eli Lilly and Company has not followed patients after a course of therapy to successful pregnancy to determine an appropriate time frame once off the drug and before becoming pregnant.
Enclosed Prescribing Information
1Forteo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.
Date of Last Review: October 18, 2022