Denosumab Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Osteoporosis

Prolia(R): 60 mg subcutaneously once every 6 months

Comments:
-If a dose is missed, the injection should be administered as soon as the patient is available. Thereafter, injections should be scheduled every 6 months from the date of the last injection.

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

Usual Adult Dose for Giant Cell Tumor of Bone

Xgeva (R): Initial dose: 120 mg subcutaneously on Days 8 and 15 of the first month of therapy in the upper arm, upper thigh, or abdomen
Maintenance dose: 120 mg subcutaneously every 4 weeks in the upper arm, upper thigh, or abdomen

Comments:
-Calcium and vitamin D should be administered to treat or prevent hypocalcemia.

Use: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Usual Adult Dose for Osteolytic Bone Metastases of Solid Tumors

Xgeva(R): 120 mg subcutaneously every 4 weeks

Comments:
-Calcium and vitamin D should be administered to treat or prevent hypocalcemia.

Use: Prevention of skeletal-related events in patients with bone metastases from solid tumors

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Data not available

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Prolia. It includes a medication guide and communication plan. For additional information: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Administer injection in the upper arm, the upper thigh, or the abdomen. Adequately supplement all patients with calcium and vitamin D.
-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).

Storage requirements:
-Store this drug in a refrigerator at 2C to 8C (36F to 46F).
-Do not freeze.
-Prior to administration, this drug may be allowed to reach room temperature (up to 25C/77F).
-Once removed from the refrigerator, this drug should not be exposed to temperatures above 25C/77F and should be used within 14 days.
-Protect from direct light and heat

Reconstitution/preparation techniques:
-Refer to manufacturer product information

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