Skip to Content

Denosumab Dosage

Medically reviewed on January 23, 2018.

Applies to the following strengths: 60 mg/mL; 120 mg/1.7 mL

Usual Adult Dose for Osteoporosis

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

Comments:
-This drug should be injected into the upper arm, upper thigh, or abdomen.
-If a dose is missed, the injection should be administered as soon as possible. Thereafter, injections should be scheduled every 6 months from the date of the last injection.

Uses:
-For postmenopausal women with osteoporosis at high risk for fracture (e.g., history of osteoporotic fracture, or multiple risk factors for fracture) or patients who have failed or are intolerant to other osteoporosis therapy; this drug reduces the incidence of vertebral, nonvertebral, and hip fractures
-To increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy
-Treatment of bone loss in men receiving androgen deprivation therapy for prostate cancer to reduce the incidence of vertebral fractures
-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): 120 mg subcutaneously every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy

Comments:
-This drug should be injected into the upper arm, upper thigh, or abdomen.
-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:
-This drug should be injected into the upper arm, upper thigh, or abdomen.
-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

Usual Adult Dose for Hypercalcemia of Malignancy

Xgeva(R): 120 mg subcutaneously every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy

Comment:
-This drug should be injected into the upper arm, upper thigh, or abdomen.

Use: Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy

Usual Pediatric Dose for Giant Cell Tumor of Bone

13 years and older and 45 kg or more:
Xgeva (R): 120 mg subcutaneously every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy

Comment:
-Xgeva (R) was studied in adolescent patients aged 13 to 17 years with giant cell tumor of bone who had reached skeletal maturity, defined by at least 1 mature long bone (e.g., closed epiphyseal growth plate of the humerus), and had a body weight of 45 kg or more.

Use: Treatment of skeletally mature adolescents with giant cell tumor of bone

Renal Dose Adjustments

Mild to moderate renal dysfunction: Data not available
Severe renal dysfunction (CrCl less than 30 mL/min): Use with caution.
.

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 a communication plan. For additional information: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

Safety and efficacy have not been established in patients younger than 18 years, except skeletally mature adolescents 13 years and older and 40 kg or more with giant cell tumor of bone.

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.
-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 30 days.
-Protect from direct light and heat

Monitoring:
-Monitoring of calcium levels in patients with severe renal impairment (CrCl less than 30 mL/min) or receiving dialysis is recommended. If hypocalcemia occurs while receiving this drug, additional calcium supplementation may be necessary.

Patient advice:
-Patients should report any problems with mouth or teeth before starting treatment; if patients wear dentures they should make sure their dentures fit properly before starting treatment.
-Maintain good oral hygiene and get routine dental check-ups during treatment.
-Healthcare providers and the dentist should know that patients are receiving this drug if they need dental treatment or dental surgery.
-Patients should report immediately any problems with their mouth or teeth during treatment (e.g., loose teeth, pain, swelling, non-healing sores or discharge).

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide