Manufacturer: Lilly, France, for Eli Lilly and Company, Indianapolis, IN
Indication: Stimulation of new bone formation in patients with osteoporosis
Drug Class: Teriparatide is a recombinant human parathyroid hormone (PTH), which is the primary regulator of calcium and phosphate metabolism in bones. It has an identical sequence to the 34N-terminal amino acids (the biologically active region) of the 84-amino acid human PTH.
Uniqueness of Drug: Patients taking teriparatide 20 mcg/day, along with calcium and vitamin D supplementation, experience statistically significant increases in bone mineral density at the spine and hip compared with patients who are receiving only calcium and vitamin D supplementation. Teri-paratide works by increasing the action of osteoblasts, the body’s bone-building cells. As a result, the bones become denser and more resistant to fractures. Teriparatide reduces the risk of vertebral and nonvertebral fractures in post-menopausal women.
“Black-Box” Warnings: In male and female rats, teri-paratide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and duration of treatment. The effect was observed at systemic exposures to teriparatide ranging from three to 60 times the exposure in humans who were given a 20-mcg dose.
Because of the uncertain relevance of the osteosarcoma finding to humans, teriparatide should be prescribed only when the potential benefits are considered to outweigh the risks in each patient. Teriparatide is contraindicated for the following groups:
- patients who are at increased risk, at baseline evaluation, for osteosarcoma, including patients with Paget’s disease of bone or with unexplained elevations of alkaline phosphatase, open epiphyses, or prior radiation therapy involving the skeleton
- children or growing adults
- patients with bone metastases or with a history of skeletal malignancies
- patients with metabolic bone diseases other than osteoporosis
- patients with high levels of calcium in the blood, because of the possibility of increasing the degree of hypercalcemia.
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Dosage and Administration: Teriparatide 20 mcg is administered once a day as a subcutaneous self-injection into the thigh or abdominal wall. For the initial dose, the patient should be able to sit or lie down if symptoms of orthostatic hypotension occur. The drug is available in a 3-ml disposable pen device that can be used for up to 28 days after the first dose has been taken.
P&T Committee Considerations: Teriparatide injection is based on the patient’s level of PTH, which is ordinarily secreted by tiny glands in the neck. It is the first in a new class of drugs called bone-formation agents, which stimulate new bone by increasing the number and action of osteoblasts.
Teriparatide injection is intended for the treatment of osteoporosis in postmenopausal women who are at high risk for bone fractures, and the drug is approved as a means of increasing bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. The drug is also indicated for men (or women) with a history of osteoporosis-related fracture, individuals with multiple risk factors for fracture, or patients who have not responded to, or who were intolerant to, previous osteoporosis therapy.
Teriparatide injection should not be considered the primary medication in the formulary for the treatment of osteoporosis, but prescribing physicians should carefully consider it for possible use.
The AWP for a single 3-ml pen device is $560.00.