Important Safety Information
Indications for use
BONSITY is indicated:
- For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, BONSITY reduces the risk of vertebral and nonvertebral fractures.
- To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.
- For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.
Contraindications
BONSITY is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. Reactions have included angioedema and anaphylaxis.
Warnings and Precautions
Osteosarcoma: An increased incidence of osteosarcoma was observed in male and female rats treated with BONSITY. Osteosarcoma has been reported in patients treated with BONSITY in the post marketing setting. There are limited data assessing the risk of osteosarcoma beyond 2 years of BONSITY use. Avoid use in patients with: open epiphyses; metabolic bone diseases including Paget's disease of the bone; bone metastases or history of skeletal malignancies; prior external beam or implant radiation therapy involving the skeleton; and hereditary disorders predisposing to osteosarcoma.
Hypercalcemia and Cutaneous Calcification: BONSITY may cause hypercalcemia and may exacerbate hypercalcemia. Avoid BONSITY in patients known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism.
Serious reports of calciphylaxis and worsening of previously stable cutaneous calcification have been reported in patients taking BONSITY. Risk factors include underlying autoimmune disease, kidney failure, and concomitant warfarin or systemic corticosteroid use. Discontinue in patients developing calciphylaxis or worsening of previously stable cutaneous calcification.
Risk of Urolithiasis: BONSITY has not been studied in patients with active urolithiasis. If BONSITY-treated patients have pre-existing hypercalciuria or suspected/known active urolithiasis, consider measuring urinary calcium excretion. Consider the risks and benefits in patients with active or recent urolithiasis because of risk of exacerbation.
Orthostatic Hypotension: BONSITY should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur.
Risk of Digoxin Toxicity: Hypercalcemia may predispose patients to digitalis toxicity because BONSITY transiently increases serum calcium.
Adverse reactions
The most common adverse reactions in clinical trials included: arthralgia, pain, and nausea. Other adverse reactions include dizziness and leg cramps.
Use in specific populations
Pregnancy and Lactation
There is no available data on BONSITY use in pregnant women. Consider discontinuing when pregnancy is recognized.
It is not known whether teriparatide 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 full Prescribing Information, including Medication Guide, and full User Manual that accompanies the delivery device.
You are encouraged to report negative side effects of prescription drugs to Alvogen at 1-866-770-3024 or the FDA at www.fda.gov/medwatch, or call 1-800-FDA-1088.
