1. Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors 2. 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 3. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy

Bone Resorption Inhibitors

Bioavailability 62% (SC). Steady-state achieved by 6 months with mean trough concentration 20.5 ± 13.5 mcg/mL. Mean elimination half-life 28 days. Clearance proportional to body weight; no effect from age, gender, race, or renal impairment.

Hypocalcemia (pre-existing hypocalcemia must be corrected prior to initiating therapy) Known clinically significant hypersensitivity to Xgeva or denosumab products

Can cause fetal harm. Verify pregnancy status prior to initiation. Advise females of reproductive potential to use effective contraception during therapy and for at least 5 months after last dose.

No information on presence in human milk. Consider benefits of breastfeeding along with mother's clinical need for Xgeva and potential adverse effects on breastfed child.

Bone metastases (?25%): Fatigue/asthenia (45%), hypophosphatemia (32%), nausea (31%). Multiple myeloma (?10%): Diarrhea (34%), nausea (32%), anemia (22%), back pain (21%), hypocalcemia (16%). Serious: Severe hypocalcemia (3.1%), osteonecrosis of jaw (1.8-7%), atypical femoral fracture.

120 mg SC every 4 weeks in upper arm, upper thigh, or abdomen. For giant cell tumor and hypercalcemia of malignancy: additional 120 mg doses on Days 8 and 15 of first month. Administer calcium and vitamin D as necessary.

Not established except in skeletally mature adolescents (12-16 years) with giant cell tumor of bone.

No adjustment required. Monitor calcium levels closely in patients with CrCl <30 mL/min or on dialysis; adequately supplement with calcium and vitamin D.

No dosage adjustments provided in manufacturer's labeling.

Store refrigerated at 2°C to 8°C in original carton. May bring to room temperature up to 25°C (takes 15-30 minutes). Once removed from refrigerator, must be used within 30 days. Do not freeze. Avoid vigorous shaking.