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T O P R E V E N T B O N E C O M P L I C A T I O N S *
IN MULTIPLE MYELOMA 1
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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 . A number of reports note that patients were also receiving treatment with glucocorticoids ( e . g . prednisone ) at the time of fracture . During XGEVA ® treatment , patients should be advised to report new or unusual thigh , hip , or groin pain . Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture . Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb . Interruption of XGEVA ® therapy should be considered , pending a risk / benefit assessment , on an individual basis .
Hypercalcemia Following Treatment Discontinuation in Patients with Growing Skeletons
• Clinically significant hypercalcemia has been reported in XGEVA ® treated patients with growing skeletons , weeks to months following treatment discontinuation . Monitor patients for signs and symptoms of hypercalcemia and treat appropriately .
Embryo-Fetal Toxicity
• XGEVA ® can cause fetal harm when administered to a pregnant woman . Based on findings in animals , XGEVA ® is expected to result in adverse reproductive effects .
• Advise females of reproductive potential to use highly effective contraception during therapy , and for at least 5
months after the last dose of XGEVA ® . Apprise the patient of the potential hazard to a fetus if XGEVA ® is used during pregnancy or if the patient becomes pregnant while patients are exposed to XGEVA ® .
Adverse Reactions
• The most common adverse reactions in patients receiving XGEVA ® with bone metastasis from solid tumors were fatigue / asthenia , hypophosphatemia , and nausea . The most common serious adverse reaction was dyspnea . The most common adverse reactions resulting in discontinuation were osteonecrosis and hypocalcemia .
• For multiple myeloma patients receiving XGEVA ® , the most common adverse reactions were diarrhea , nausea , anemia , back pain , thrombocytopenia , peripheral edema , hypocalcemia , upper respiratory tract infection , rash , and headache . The most common serious adverse reaction was pneumonia . The most common adverse reaction resulting in discontinuation of XGEVA ® was osteonecrosis of the jaw .
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Hazard ratio ( HR ) is defined as the increase or decrease in likelihood of an event of interest ( in this case , a bone complication ) for one group relative to a comparator group .
Please see brief summary of Full Prescribing Information on the following page .
Reference : 1 . XGEVA ® ( denosumab ) prescribing information , Amgen .
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