Postmenopausal Osteoporosis Treatments
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Generic Name
Teriparatide
Brand Names
Bonsity, Forteo
FDA approval date: November 26, 2002
Classification: Parathyroid Hormone Analog
Form: Injection
What is Bonsity (Teriparatide)?
BONSITY is indicated: For the treatment of postmenopausal women with osteoporosis at high risk 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 at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. BONSITY is a parathyroid hormone analog, , indicated for: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy
Approved To Treat
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Brand Information
Bonsity (teriparatide)
1INDICATIONS AND USAGE
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.
2DOSAGE FORMS AND STRENGTHS
Injection: 560 mcg/2.24 mL (250 mcg/mL)
Colorless solution in a single-patient-use prefilled pen intended to deliver 28 daily doses of 20 mcg.
3CONTRAINDICATIONS
BONSITY is contraindicated in patients with a history of severe hypersensitivity to teriparatide or any of the inactive ingredients of BONSITY. Reactions have included anaphylaxis and angioedema
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
Hypersensitivity Reactions Osteosarcoma Hypercalcemia and Cutaneous Calcification Risk of Urolithiasis Orthostatic Hypotension Risk of Digoxin Toxicity
4.1Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
4.2Postmarketing Experience
Adverse Reactions from Postmarketing Spontaneous Reports
The following adverse reactions have been identified during post-approval use of teriparatide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Cases of bone tumor and osteosarcoma have been reported rarely in the postmarketing period
- Hypercalcemia greater than 13 mg/dL has been reported with teriparatide use.
Adverse events reported since market introduction that were temporally related to teriparatide therapy include the following:
- Allergic Reactions: Anaphylactic reactions, drug hypersensitivity, angioedema, urticaria
- Investigations: Hyperuricemia
- Respiratory System: Acute dyspnea, chest pain
- Musculoskeletal: Muscle spasms of the leg or back
- Other: Injection site reactions including injection site pain, swelling and bruising; oro-facial edema
Adverse Reactions from Observational Studies to Assess Incidence of Osteosarcoma
Two osteosarcoma surveillance safety studies (U.S. claims-based database studies) were designed to obtain data on the incidence rate of osteosarcoma among teriparatide-treated patients. In these two studies, three and zero osteosarcoma cases were identified among 379,283 and 153,316 teriparatide users, respectively. The study results suggest a similar risk for osteosarcoma between teriparatide users and their comparators. However, the interpretation of the study results calls for caution owing to the limitations of the data sources which do not allow for complete measurement and control for confounders.
5OVERDOSAGE
In postmarketing spontaneous reports, there have been cases of medication errors in which the entire contents (up to 800 mcg) (40 times the recommended dose) of the teriparatide prefilled delivery device (pen) have been administered as a single dose. Transient events reported have included nausea, weakness/lethargy and hypotension. No fatalities associated with overdose have been reported. Additional signs, symptoms, and complications of teriparatide overdosage may include a delayed hypercalcemic effect, vomiting, dizziness, and headache.
Overdose Management - There is no specific antidote for a teriparatide overdosage. Treatment of suspected overdosage should include discontinuation of BONSITY, monitoring of serum calcium and phosphorus, and implementation of appropriate supportive measures, such as hydration.
6DESCRIPTION
BONSITY (teriparatide injection) is a recombinant human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone.
The molecular formula of teriparatide is C
Teriparatide is manufactured using a strain of
Each cartridge, pre-assembled into a delivery device, delivers 20 mcg of teriparatide per dose each day for up to 28 days. Each device contains additional volume to allow troubleshooting of the device 2 times.
7PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Medication Guide and the User Manual) before starting BONSITY and each time the prescription is renewed. Failure to follow the instructions may result in inaccurate dosing.
Hypersensitivity Reactions
Advise patients that serious hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, can occur with BONSITY. Advise patients to discontinue BONSITY and promptly seek medical attention if signs or symptoms of hypersensitivity reactions occur
Osteosarcoma
Patients should be made aware that in rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor). Although cases of osteosarcoma have been reported in patients using teriparatide, no increased risk of osteosarcoma was observed in adult humans treated with teriparatide
Hypercalcemia
Instruct patients taking BONSITY to contact a health care provider if they develop persistent symptoms of hypercalcemia (e.g., nausea, vomiting, constipation, lethargy, muscle weakness)
Orthostatic Hypotension
When initiating BONSITY treatment, instruct patients to be prepared to immediately sit or lie down during or after administration in case they feel lightheaded or have palpitations after the injection. Instruct patients to sit or lie down until the symptoms resolve. If symptoms persist or worsen, instruct patients to consult a healthcare provider before continuing treatment
Other Osteoporosis Treatment Modalities
Patients should be informed regarding the roles of supplemental calcium and/or vitamin D.
Use of Delivery Device (Pen)
Instruct patients and caregivers who administer BONSITY on how to properly use the delivery device (refer to User Manual), to properly dispose of needles, and not to share their delivery device with other patients. Instruct patients and caregivers who administer BONSITY that the contents of the delivery device should not be transferred to a syringe.
Inform patients that each BONSITY delivery device can be used for up to 28 days. Instruct patients to discard the BONSITY delivery device 28 days after first use, even if it still contains some unused solution. Instruct patients not to use BONSITY after the expiration date printed on the delivery device and packaging.
8PRINCIPAL DISPLAY PANEL - Carton
Do NOT transfer contents to a syringe.
NDC 47781-
ATTENTION PHARMACIST: Medication Guide (attached to Prescribing Information) and device User Manual for patient inside carton.
BONSITY
teriparatide injection
560 mcg/2.24 mL (250 mcg/mL)
teriparatide injection
560 mcg/2.24 mL (250 mcg/mL)
20 mcg per dose (given once daily subcutaneously)
For Single-Patient-Use Only
Rx Only
