Concise Prescribing Info
Prevention of skeletal-related events in patients w/ multiple myeloma & bone metastases from solid tumors. Giant cell tumor of the bone that is unresectable or where surgical resection is likely to result in severe morbidity in adults or skeletally mature adolescents. Hypercalcemia of malignancy refractory to bisphosphonate therapy.
Dosage/Direction for Use
SC Administer inj in the upper arm, upper thigh or abdomen. Multiple myeloma & bone metastasis from solid tumors 120 mg once every 4 wk. Giant cell tumor of bone & hypercalcemia of malignancy 120 mg every 4 wk, w/ additional 120 mg on days 8 & 15 of 1st mth therapy.
Hypersensitivity. Hypocalcemia.
Special Precautions
Do not administer IV, IM or intradermally. Do not take w/ Prolia. Discontinue in case of anaphylaxis or other clinically significant allergic reactions. Correct pre-existing hypocalcemia prior to initiation of therapy. Osteonecrosis of the jaw, w/ risk factors eg, immunosuppressive therapy, treatment w/ angiogenesis inhibitors, systemic corticosteroids, diabetes & gingival infections. Perform oral exam & appropriate preventive dentistry prior to initiation & periodically. Avoid invasive dental procedures. Atypical femoral fracture. Hypercalcemia following treatment discontinuation in patients w/ giant cell bone tumor & growing skeleton. Patient who presents w/ thigh or groin pain should be suspected of having an atypical fracture & should be evaluated to rule out an incomplete femur fracture. Monitor calcium levels especially on 1st wk of initiating therapy; signs & symptoms of hypercalcemia. Assess serum Ca periodically. Evaluate the patient's risk for multiple vertebral fractures especially those w/ risk factors for or a history of osteoporosis or prior fractures. Severe renal impairment (CrCl <30 mL/min) &/or on dialysis. Effective contraception in females of reproductive potential should be used during therapy, & for at least 5 mth after the last dose. Pregnancy & lactation. Childn except in skeletally mature adolescents w/ giant cell tumor bone tumor. May impair bone growth in childn w/ open growth plates & may inhibit eruption of dentition.
Adverse Reactions
Fatigue/asthenia, hypophosphatemia, nausea; dyspnea; osteonecrosis of the jaw, hypocalcemia; diarrhea; back pain; peripheral edema; headache; anemia. In bone metastases from solid tumors: Asthenia. In multiple myeloma: Thrombocytopenia, upper resp tract infection, rash; pneumonia. In giant cell bone tumor: Arthralgia & pain in extremity; osteomyelitis, tooth abscess or infection. In hypercalcemia of malignancy: Decreased appetite, vomiting, constipation. Infection; hypomagnesemia, hypokalemia.
Drug Interactions
Immunosuppressive therapy, angiogenesis inhibitors, systemic corticosteroids.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BX04 - denosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
Xgeva 120 mg/1.7 mL (70 mg/mL)
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