Applies to the following strength(s): 600 mcg/2.4 mL ; 750 mcg/3 mL
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Osteoporosis
20 mcg subcutaneously once a day into the thigh or abdominal wall
-Treatment of postmenopausal women with osteoporosis at high risk for fracture
-Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture
-Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
Data not available; however, hepatic impairment is unlikely to significantly affect the systemic exposure of this drug since hepatic Kupffer cells are considered its primary site of metabolism.
US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for teriparatide. It includes a medication guide and communication plan. For additional information: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
US BOXED WARNINGS:
Potential Risk of Osteosarcoma:
-This drug caused an increase in the incidence of osteosarcoma (a malignant bone tumor) in male and female rats that was dependent on dose and treatment duration. The effect was observed at systemic exposures 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, this drug should be prescribed only for patients for whom the potential benefits are considered to outweigh the potential risk. This drug 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).
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-The use of this drug for more than 2 years has not been evaluated and is not recommended.
-This drug should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur.
-Adequate intake of calcium and vitamin D should be ensured. When therapy has been ceased, patients may be continued on other osteoporosis therapies.
-Patients should receive education on the proper injection techniques of this drug.
-Data are not available on the safety or efficacy of IV or IM administration of this drug.
-The pens for subcutaneous administration should be stored between 2 to 8 degrees C (36 to 46 degrees F), and should be administered as soon as possible after removal from the refrigerator.
-Each pen should be used within 28 days after the first injection.
-This drug should not be frozen.
-The delivery device should be recapped when not in use to protect the cartridge from physical damage and light.
More about teriparatide
- Other brands: Forteo