ASH Clinical News ACN_4.5_FULL_ISSUE_DIGITAL - Page 3

NOW AVAILABLE 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* I N M U LT I P L E M Y E L O M A 1 Visit for clinical study results and more information 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 as sessed 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 Growing Skeletons • Clinically signifi cant 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. 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. 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. † Please see brief summary of Full Prescribing Information on the following page. Reference: 1. XGEVA ® (denosumab) prescribing information, Amgen. Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 © 2018 Amgen Inc. All rights reserved. USA-162x-057031(1) 03/18