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I N M U LT I P L E M Y E L O M A 1
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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
www.amgen.com
© 2018 Amgen Inc.
All rights reserved.
USA-162x-057031(1) 03/18