Bone-Modifying Agent; Monoclonal Antibody

Indications:

Tumors: Prevention of skeletal-related events (eg, fracture, spinal cord compression, bone pain requiring surgery/radiation therapy) in patients with bone metastases from solid tumors.

Treatment of giant cell tumor of the bone in adults and skeletally mature adolescents that is unresectable or where surgical resection is likely to result in severe morbidity.

Note: NOT indicated for prevention of skeletal-related events in patients with multiple myeloma.

Note: Duplicate therapy issues: Prolia contains denosumab, which is the same ingredient contained in Xgeva; patients receiving Xgeva should not be treated with Prolia.

Contra-indications: Hypersensitivity to denosumab or any component of the formulation; preexisting hypocalcemia.

Renal impairment: increased risk of hypocalcaemia if eGFR less than 30 ml/minute/1.73 m2—monitor plasma- calcium concentration.

Pregnancy: avoid

Breast-feeding: avoid

Side Effects: diarrhoea, constipation, dyspnea, urinary tract infection, upper respiratory tract infection, pain in extremity, sciatica, hypocalcaemia (fatal cases reported), hypophosphataemia, cataracts, rash, sweating; less commonly diverticulitis, cellulitis (seek prompt medical attention), ear infection; rarely osteonecrosis of the jaw, atypical femoral fractures.

Dose: Note: Administer calcium and vitamin D as necessary to prevent or treat hypocalcemia.

Prevention of skeletal-related events in bone metastases from solid tumors SubQ: 120 mg every 4 weeks.

Treatment of giant cell tumor of the bone (Xgeva): SubQ: 120 mg once every 4 weeks; during the first month, give an additional 120 mg on days 8 and 15.