ASH Clinical News ACN_4.5_FULL_ISSUE_DIGITAL - Page 2

Y O U A N O W D I F F E R E N T H A V E O P T I O N * 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,