POTENTIAL RISK OF OSTEOSARCOMA: In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. The effect was observed at systemic exposures to teriparatide ranging from 3 to 60 times the exposure in humans given a 20-mcg dose. Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe teriparatide (rDNA origin) injection only for patients for whom the potential benefits are considered to outweigh the potential risk. Teriparatide (rDNA origin) injection should not be prescribed for patents who are at increased baseline risk for osteosarcoma including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy involving the skeleton.
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