Usual Adult Dose for Osteoporosis

20 mcg subcutaneously once a day into the thigh or abdominal wall

• Duration of Therapy: Lifetime use greater than 2 years should only be considered if fracture risk remains high

• This drug is indicated for men and women as described below who are at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.
• High fracture is defined as history of osteoporotic fracture or multiple risk factors for fracture.
• Supplemental calcium and vitamin D should be taken if daily dietary intake is inadequate.

• For the treatment of postmenopausal women with osteoporosis
• To increase bone mass in men with primary or hypogonadal osteoporosis
• For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid (equivalent to prednisone 5 mg/day or greater)

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active ingredient or any product ingredients; hypersensitivity reactions have included angioedema and anaphylaxis

Dialysis

Data not available

Other Comments

Administration advice:

• For subcutaneous administration only; not for IM or IV use
• Administer subcutaneously once a day into thigh or abdominal region
• Patients should be instructed on proper administration technique
• Initial doses of this drug should be administered in settings where patient can sit or lie down if symptoms of orthostatic hypotension occur

• Store under refrigeration 2 to 8 degrees C (36 to 46 degrees F) at all times except when administering product; limit time out of refrigerator
• Once opened, can be used for up to 28 days; discard after 28 days
• Do not freeze; do not use if it has been frozen
• Store with cap on to protect from physical damage and light

• Supplemental calcium and vitamin D should be given if dietary intake is inadequate.
• In postmenopausal women with osteoporosis, this drug has been shown to reduce the risk of vertebral and nonvertebral fractures.
• Use for more than 2 years during a patient's lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture as there is limited data assessing the risk of osteosarcoma beyond 2 years of use.

• Observe for orthostatic hypotension, especially with first few doses
• Consider measuring urinary calcium excretion in patients with active or recent urolithiasis

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Patients should be aware that an increased incidence of osteosarcoma has been observed in rat studies, but observational human studies have not shown this risk for use up to 2 years.
• Patients should be instructed to notify their healthcare provider if they develop persistent symptoms of hypercalcemia.

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