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.
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