ASH Clinical News ACN_4.14_Full Issue_web | Page 125

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 fi rst 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 V I S I T XG E VA . C O M / H C P / M M FO R M O R E I N FO R M AT I O N 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/benefi t 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 signifi cant 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 fi ndings 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, defi ned 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 defi ned 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 fi le, 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. Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 www.amgen.com © 2018 Amgen Inc. All rights reserved. USA-162X-80115 07/18