Forteo ® (teriparatide [rDNA origin] injection)

20-mcg daily dose in a 2.4-mL prefilled delivery device

The below information is provided in response to your request and may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above.

Osteosarcoma Data in Patients Treated with FORTEO® (teriparatide [rDNA origin] injection)

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

Potential risk of osteosarcoma

In rats, Forteo® (teriparatide [rDNA origin] injection) caused a dose-dependent increase in the incidence of osteosarcoma, a malignant bone tumor. Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe teriparatide only for patients for whom potential benefits outweigh potential risk (Forteo Package Insert, 2012).

Teriparatide should not be prescribed for patients at increased baseline risk for osteosarcoma. Increased risks include (Forteo Package Insert, 2012):

  • Paget’s disease of bone

  • Unexplained elevations of alkaline phosphatase (elevations in alkaline phosphatase may signal undiagnosed Paget’s disease of bone)*

  • Pediatric and young adult patients with open epiphyses

  • Prior external beam or implant radiation therapy involving the skeleton

*Note: teriparatide treatment has been shown to elevate bone specific alkaline phosphatase as part of its mechanism of action; this elevation is expected.

Clinical experience

Among the more than 16000 patients who received teriparatide in controlled clinical trials and observational studies over a span of 15 years, the largest of which included approximately 4000 patients treated for up to 2 years and followed for an additional 2 years, no cases of osteosarcoma have been reported (Andrews, 2012).

Postmarketing Experience

Cases of bone tumor and osteosarcoma have been reported rarely in the postmarketing period. The causality to teriparatide use is unclear (Forteo Package Insert, 2012).

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 (Forteo Package Insert, 2012).

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

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

References

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.

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

Date of Last Review: February 09, 2017

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