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* Bone complications, also known as skeletal-related events (SREs), are defi ned as radiation to bone, pathologic
fracture, surgery to bone, and spinal cord compression. 1
In a randomized, double-blind, phase 3 study (N=1,718) assessing time to fi rst on-study bone complication in patients with
bone lesions from multiple myeloma, XGEVA ® was noninferior to zoledronic acid in delaying time to fi rst on-study bone
complication (median 22.8 months vs 24 months, respectively) (HR=0.98 [95% CI: 0.85-1.14]). 1†
Indication
XGEVA is indicated for the prevention of skeletal-related
events in patients with multiple myeloma and in patients
with bone metastases from solid tumors.
®
Important Safety Information
Hypocalcemia
• Pre-existing hypocalcemia must be corrected prior to
initiating therapy with XGEVA ® . XGEVA ® can cause severe
symptomatic hypocalcemia, and fatal cases have been
reported. Monitor calcium levels, especially in the fi rst
weeks of initiating therapy, and administer calcium,
magnesium, and vitamin D as necessary. Monitor levels
more frequently when XGEVA ® is administered with other
drugs that can also lower calcium levels. Advise patients
to contact a healthcare professional for symptoms of
hypocalcemia.
• An increased risk of hypocalcemia has been observed in
clinical trials of patients with increasing renal dysfunction,
most commonly with severe dysfunction (creatinine
clearance less than 30 mL/minute and/or on dialysis), and
with inadequate/no calcium supplementation. Monitor
calcium levels and calcium and vitamin D intake.
Hypersensitivity
• XGEVA ® is contraindicated in patients with known clinically
signifi cant hypersensitivity to XGEVA ® , including anaphylaxis that
has been reported with use of XGEVA ® . Reactions may include
hypotension, dyspnea, upper airway edema, lip swelling, rash,
pruritus, and urticaria. If an anaphylactic or other clinically
signifi cant allergic reaction occurs, initiate appropriate therapy
and discontinue XGEVA ® therapy permanently.
Drug Products with Same Active Ingredient
• Patients receiving XGEVA ® should not take Prolia ®
(denosumab).
Osteonecrosis of the Jaw
• Osteonecrosis of the jaw (ONJ) has been reported in patients
receiving XGEVA ® , manifesting as jaw pain, osteomyelitis,
osteitis, bone erosion, tooth or periodontal infection,
toothache, gingival ulceration, or gingival erosion. Persistent
pain or slow healing of the mouth or jaw after dental surgery
may also be manifestations of ONJ. In clinical trials in
patients with cancer, the incidence of ONJ was higher with
longer duration of exposure.
• Patients with a history of tooth extraction, poor oral hygiene, or
use of a dental appliance are at a greater risk to develop
ONJ. Other risk factors for the development of ONJ include
immunosuppressive therapy, treatment with angiogenesis
inhibitors, systemic corticosteroids, diabetes, and gingival infections.
• Perform an oral examination and appropriate preventive
dentistry prior to the initiation of XGEVA ® and periodically
during XGEVA ® therapy. Advise patients regarding oral hygiene
practices. Avoid invasive dental procedures during treatment
with XGEVA ® . Consider temporarily interrupting XGEVA ®
therapy if an invasive dental procedure must be performed.
• Patients who are suspected of having or who develop ONJ
while on XGEVA ® should receive care by a dentist or an oral
surgeon. In these patients, extensive dental surgery to treat
ONJ may exacerbate the condition.
Atypical Subtrochanteric and Diaphyseal Femoral Fracture
• Atypical femoral fracture has been reported with XGEVA ® .
These fractures can occur anywhere in the femoral
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,