XGEVA ® was proven to prevent bone complications in the largest international trial ever conducted in multiple myeloma 2 , 4
The # 1 oncologist-prescribed bone-targeting agent to prevent bone complications in patients with bone metastases from solid tumors is also indicated for patients with multiple myeloma 2 , 3 †
XGEVA ® was proven to prevent bone complications in the largest international trial ever conducted in multiple myeloma 2 , 4
XGEVA ® was found to be noninferior to zoledronic acid ( ZA ) in delaying time to first on-study bone complication in patients with bone lesions from multiple myeloma . XGEVA ® prevented bone complications for a median of 22.8 months vs 24 months for ZA ( HR = 0.98 [ 95 % CI : 0.85-1.14 ]) 2 ‡
Start XGEVA ® for your patients with multiple myeloma to prevent bone complications 2
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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 Giant Cell Tumor of Bone ( GCTB ) and in
Patients with Growing Skeletons
• Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in XGEVA ® -treated patients with GCTB and in patients with growing skeletons within one year of treatment discontinuation . Monitor patients for signs and symptoms of hypercalcemia after treatment discontinuation and treat appropriately .
Multiple Vertebral Fractures ( MVF ) Following Treatment Discontinuation
• 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 .
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 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 .
Please see brief summary of Full Prescribing Information on the following page .
†
Based on the Oncology Services Comprehensive Electronic Records ( OSCER ) electronic health record database including patients with a diagnosis of a solid tumor and bone metastases ( ICD-9 198.5 ) who were treated with a bone-targeting agent , defined as pamidronate , zoledronic acid , or denosumab . A 3-month rolling average was applied to the data , and current at the time of publication . 3
‡
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 .
References : 1 . Roodman GD . Pathogenesis of myeloma bone disease . Leukemia . 2009 ; 23 ( 3 ): 435-441 . 2 . XGEVA ® ( denosumab ) prescribing information , Amgen . 3 . Data on file , Amgen . 4 . Raje N , Terpos E , Willenbacher W , et al . Denosumab versus zoledronic acid in bone disease treatment of newly diagnosed multiple myeloma : an international , double-blind , double-dummy , randomised , controlled , phase 3 study . Lancet Oncol . 2018 ; 19 ( 3 ): 370-381 .
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