ASH Clinical News ACN_4.4_FULL_ISSUE_DIGITAL | Page 49
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 XGEVA.com/hcp/mm for clinical study results and more information
shaft from just below the lesser trochanter to above the
supracondylar fl are and are transverse or short oblique in
orientation without evidence of comminution.
• Atypical femoral fractures most commonly occur with
minimal or no trauma to the affected area. They may be
bilateral and many patients report prodromal pain in the
affected area, usually presenting as dull, aching thigh pain,
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 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 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.
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 highly
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 02/18