Forteo ® (teriparatide [rDNA origin] 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.

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

Forteo is classified as pregnancy category C. There are no adequate and well controlled studies of Forteo in pregnant or nursing women.

Pregnancy During Teriparatide Treatment

Forteo® (teriparatide [rDNA origin] injection) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (Forteo Package Insert, 2012).

Animal Studies

Based on animal studies, use during pregnancy may cause fetal harm.

Pregnant mice received teriparatide during organogenesis at subcutaneous doses 8 to 267 times the human dose (Forteo Package Insert, 2012).

  • At doses > 60 times the human dose, the fetuses showed an increased incidence of skeletal deviations or variations (interrupted rib, extra vertebra or rib).

Nursing During Teriparatide Treatment

It is not known whether teriparatide is excreted in human milk. Because of the potential for tumorigenicity shown with teriparatide in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (Forteo Package Insert, 2012).

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 (Forteo Package Insert, 2012).

  • Mild growth retardation in female offspring occurred at doses >120 times the human dose (based on surface area, mcg/m2).

  • Mild growth retardation in male offspring and reduced motor activity in both male and female offspring occurred at maternal doses 540 times the human dose.

  • There were no developmental or reproductive effects in mice or rats at doses 8 or 16 times the human dose, respectively.

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

The published references below are available upon request by contacting 1-800-LillyRx.

References

FORTEO® [Package Insert]. Indianapolis, IN: Eli Lilly and Company; 2012.

Date of Last Review: February 28, 2017

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