Indicated for:

Multiple Myeloma and Bone Metastasis from Solid Tumors:

• The prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

Giant Cell Tumor of Bone:

• The 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.

Hypercalcemia of Malignancy:

• The treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Xgeva is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally.

Patients receiving Xgeva should not take Prolia.

Pre-existing hypocalcemia must be corrected prior to initiating therapy with Xgeva. Xgeva can cause severe symptomatic hypocalcemia, and fatal cases have been reported.

Osteonecrosis of the jaw (ONJ) has been reported in patients receiving Xgeva, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Avoid invasive dental procedures during treatment with Xgeva.

Atypical femoral fracture has been reported with Xgeva. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs.

Multiple vertebral fractures (MVF) have been reported following discontinuation of treatment with denosumab. Patients at higher risk for MVF include those with risk factors for or a history of osteoporosis or prior fractures. When Xgeva treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures.

Clinically significant hypersensitivity including anaphylaxis has been reported with use of Xgeva. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria.

Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in Xgeva-treated patients with giant cell tumor of bone and patients with growing skeletons. Hypercalcemia has been reported within the first year after treatment discontinuation.

Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use highly effective contraception. Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of Xgeva.

There is no information regarding the presence of Xgeva (denosumab) in human milk, the effects on the breastfed child, or the effects on milk production. Denosumab was detected in the maternal milk of cynomolgus monkeys up to 1 month after the last dose of denosumab (≤ 0.5% milk:serum ratio) and maternal mammary gland development was normal, with no impaired lactation.

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• Combined teriparatide and denosumab treatment for women with postmenopausal osteoporosis. GoToSource

• Combined denosumab and tocilizumab treatment for paget’s disease. GoToSource

• Fibrous dysplasia. GoToSource

• Prevention of bone loss due to androgen deprivation therapy in non metastatic prostate cancer, prevention of bone loss in aromatase inhibitor therapy in breast cancer and treatment of bone destruction in patients with rheumatoid arthritis. GoToSource

• Use in patients under the age of 13. GoToSource

Osteonecrosis of the jaw. GoToSource

Severe hypocalcemia (low calcium level). GoToSource

Atypical subtrochanteric and diaphyseal femoral fracture (fractures in the bone just below the hip joint). GoToSource

Endocarditis (infection of inner lining of the heart or valves) and pancreatitis (inflammation of pancreas). GoToSource

Cataracts. GoToSource

Impairment of fracture healing, upper respiratory tract infection, eczema and urinary tract infections. GoToSource

Anaphylaxis (allergic reaction), upper airway edema, lip swelling, rash, sciatica (pain along the sciatic nerve), constipation and limb pain. GoToSource

Lawsuits filed for hypocalcemia.