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.

FORTEO® (teriparatide [rDNA origin] injection): Osteosarcoma Data

Forteo should not be prescribed for patients at increased baseline risk for osteosarcoma.

Introduction

In rats, teriparatide caused a dose-dependent increase in the incidence of osteosarcoma, a malignant bone tumor.1

Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe teriparatide only for patients for whom potential benefits outweigh potential risk.1

Teriparatide should not be prescribed for patients at increased baseline risk for osteosarcoma. Increased risks include

  • Paget’s disease of bone

  • unexplained elevations of ALP (elevations in ALP may signal undiagnosed Paget’s disease of bone)

  • pediatric and young adult patients with open epiphyses, and

  • prior external beam or implant radiation therapy involving the skeleton.1

Teriparatide treatment has been shown to elevate BSAP as part of its mechanism of action; this elevation is expected.1

Clinical Experience

An analysis conducted in 2012 found that in the more than 16,000 patients who received teriparatide in controlled clinical trials and observational studies, there were no cases of osteosarcoma reported.2

Postmarketing Experience

Cases of bone tumor and osteosarcoma have been reported rarely in the postmarketing period. The causality to teriparatide use is unclear.1

The cumulative number of spontaneous reports with a pathology-confirmed diagnosis of osteosarcoma in the teriparatide-treated population does not exceed what would be predicted based on background incidence alone.3

Osteosarcoma continues to be the focus of long-term postmarketing surveillance efforts. Any communication to Lilly that includes a potential report of osteosarcoma is further investigated and reported expeditiously to the FDA and to other regulatory authorities.

Enclosed Prescribing Information

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

References

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).

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

2. Andrews EB, Gilsenan AW, Midkiff K, et al. The US postmarketing surveillance study of adult osteosarcoma and teriparatide: study design and findings from the first 7 years. J Bone Miner Res. 2012;27(12):2429-2437. https://doi.org/10.1002/jbmr.1768

3. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

ALP = bone alkaline phosphatase

BSAP = bone-specific alkaline phosphatase

FDA = Food and Drug Administration

Date of Last Review: February 11, 2020

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