Xgeva

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.

SC Administer inj in the upper arm, upper thigh or abdomen. Multiple myeloma & bone metastasis from solid tumors 120 mg 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 of therapy.

Hypersensitivity.

Do not administer IV, IM or intradermally. Do not take w/ drugs containing the same active ingredient. 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; history of invasive dental procedures. Perform oral exam & appropriate preventive dentistry prior to initiation & periodically. Avoid invasive dental procedures. 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 Ca levels especially on 1st wk of initiating therapy; signs & symptoms of hypercalcemia. Patients at higher risk for multiple vertebral fractures including those w/ risk factors for or a history of osteoporosis or prior fractures. Renal impairment. 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.

Hypocalcemia; osteonecrosis of the jaw; atypical subtrochanteric & diaphyseal femoral fracture; hypercalcemia & multiple vertebral fracture following treatment discontinuation. Musculoskeletal pain, including severe musculoskeletal pain; lichenoid drug eruptions (eg, lichen planus-like reactions); alopecia.

Immunosuppressive therapy, angiogenesis inhibitors, systemic corticosteroids may increase risk of developing osteonecrosis of the jaw.

Agents Affecting Bone Metabolism

M05BX04 - denosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.

Rx