Medically reviewed by Drugs.com. Last updated on Dec 4, 2017.
Applies to the following strengths: 3120 mcg/1.56 mL
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Osteoporosis
80 mcg subcutaneously once a day
-Cumulative use of this drug and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient's lifetime is not recommended.
-Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
Use: For the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy; in postmenopausal women with osteoporosis, this drug reduces the risk of vertebral fractures and nonvertebral fractures
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
Data not available
US BOXED WARNINGS:
RISK OF OSTEOSARCOMA:
-This drug caused a dose-dependent increase in the incidence of osteosarcoma, a malignant bone tumor, in animal studies. The effect was observed at systemic exposures ranging from 4 to 28 times the exposure in humans receiving the 80 mcg dose. It is unknown whether it can cause osteosarcoma in humans. Use is not recommended in patients at increased risk for osteosarcoma including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external beam or implant radiation therapy involving the skeleton. Cumulative use of this drug and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient's lifetime is not recommended.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Administer as a subcutaneous injection into the periumbilical region of the abdomen; rotate the site of the injection every day.
-Administer at approximately the same time every day.
-Do not administer IV or IM.
-Administer the first several doses where the patient can sit or lie down if necessary, in case symptoms of orthostatic hypotension occur.
-This drug is supplied as a clear and colorless solution. Visually inspect for particulate matter and discoloration prior to administration. Do not use if solid particles appear or if the solution is cloudy or colored.
-Provide appropriate training to patients and caregivers on the proper use of the delivery pen.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Side Effects
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- En Español
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- Drug class: parathyroid hormone and analogs
Other brands: Tymlos