Denosumab Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Osteoporosis

Treatment of men and postmenopausal women with osteoporosis at high risk for fracture, treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer, and treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer:

60 mg administered as a single subcutaneous injection in the upper arm, the upper thigh, or the abdomen once every 6 months. All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily.

Usual Adult Dose for Hypercalcemia of Malignancy

For the prevention of skeletal related events in patients with bone metastases from solid tumors:

120 mg as a subcutaneous injection in the upper arm, upper thigh, or abdomen every 4 weeks.

Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia.

Usual Adult Dose for Giant Cell Tumor of Bone

Administer 120 mg subcutaneously every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy.

Comments:
-Administer subcutaneously in the upper arm, upper thigh, or abdomen.
-Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia.

Renal Dose Adjustments

No dose adjustment is necessary in patients with renal impairment.

Liver Dose Adjustments

Data not available

Precautions

People sensitive to latex should not handle the grey needle cap on the single-use prefilled syringe, which contains dry natural rubber (a derivative of latex).

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for denosumab. It includes a Medication Guide and communication plan. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

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