When bone lesions from multiple myeloma weaken his bone 1
PREVENTING BONE COMPLICATIONS*
HELPS KEEP WHAT MATTERS INTACT
* 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. 2
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,
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