FORTEO® (teriparatide [rDNA origin] injection): During and After Pregnancy

Introduction

Teriparatide should not be administered to women who are pregnant or nursing. Lilly has not studied the effect of teriparatide treatment on human fetal development or if teriparatide is secreted in breast milk.

Pregnancy During Teriparatide Treatment

Teriparatide should be discontinued when pregnancy is determined. The effect of teriparatide on human fetal development has not been studied and the potential risk for humans is unknown.

Animal Studies

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

Animal Studies

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 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. Lilly 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

FORTEO® (teriparatide [rDNA origin] injection), Lilly

Reference

1. Forteo [package insert]. Indianapolis IN: Eli Lilly and Company; 2019.