Important Safety Information
WARNING: POTENTIAL RISK OF OSTEOSARCOMA
In male and female rats, Teriparatide Injection 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 Injection 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 Injection only for patients for whom the potential benefits are considered to outweigh the potential risk. Teriparatide Injection should not be prescribed for patients 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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Contraindications
Hypersensitivity to Teriparatide Injection or to any of its excipients. Reactions have included angioedema and anaphylaxis.
Warnings and Precautions
Teriparatide Injection should not be prescribed for patients at increased baseline risk of osteosarcoma. These patients include: Paget’s disease of bone, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy.
The safety and efficacy of Teriparatide Injection has not been evaluated beyond two years of treatment, and use for more than two years during a patient’s lifetime is not recommended.
Patients with the following should not be treated with Teriparatide Injection: bone metastases or a history of skeletal malignancies, metabolic bone diseases other than osteoporosis, or hypercalcemic disorders.
Use with caution in patients with active or recent urolithiasis because of risk of exacerbation. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered.
Teriparatide Injection should be administered so that patients can sit or lie down if symptoms of orthostatic hypotension occur. In short-term clinical studies, transient orthostatic hypotension was observed in 5% of patients.
Patients receiving digoxin should use Teriparatide Injection with caution, as it may transiently increase serum calcium and hypercalcemia may predispose patients to digitalis toxicity.
Adverse Reactions
The most common adverse reactions in clinical trials include: arthralgia (10.1% vs. 8.4% placebo), pain (21.3% vs. 20.5% placebo), and nausea (8.5% vs. 6.7% placebo). Other adverse reactions include: dizziness, leg cramps, joint aches, and injection site reactions.
Pregnancy and Lactation
There is no available data on Teriparatide Injection use in pregnant women. Consider discontinuing when pregnancy is recognized.
It is not known whether Teriparatide Injection is excreted in human milk, affects human milk production, or has effects on the breastfed infant. Breastfeeding is not recommended.
For additional safety information, please see the Prescribing Information and full User Manual that accompanies the delivery device.