Xgeva®: A single, subcutaneous injection once every 4 weeks
Convenient Administration1
- 120-mg dose (1.7-mL injection) administered with a 27-gauge needle
- Administered once every 4 weeks
- Does not require reconstitution or IV infusion equipment and resources
Treatment considerations1-9
- Xgeva® (denosumab) is not cleared by the kidneys and does not require dose adjustments, regardless of renal function
- Supplement with calcium ≥ 500 mg and vitamin D ≥ 400 IU daily as necessary to prevent or treat hypocalcemia
Storage1
- Must be refrigerated at 36°F to 46°F (2°C to 8°C)
- Upon removal from refrigeration, must not be exposed to temperatures above 77°F (25°C) or direct light and must be used within 14 days
Indication
XGEVA® (denosumab) is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.
XGEVA® is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.
Important Safety Information
Hypersensitivity-
XGEVA® (denosumab) is contraindicated in patients with clinically significant hypersensitivity to any component of the product.
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XGEVA® (denosumab) can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct pre-existing hypocalcemia prior to XGEVA® treatment. Monitor calcium levels 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.
Based on clinical trials using a lower dose of denosumab, patients with a creatinine clearance less than 30 mL/min or receiving dialysis are at greater risk of severe hypocalcemia compared to patients with normal renal function. The risk of hypocalcemia at the recommended dosing schedule of 120 mg every 4 weeks has not been evaluated in patients with a creatinine clearance less than 30 mL/min or receiving dialysis.
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Osteonecrosis of the jaw (ONJ) can occur in patients receiving XGEVA® (denosumab), 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.
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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®.
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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.
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Atypical femoral fracture has been reported with XGEVA® (denosumab). Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with anti-resorptive agents. A number of reports note that patients were also receiving treatment with glucocorticoids at the time of fracture. 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. Interruption of XGEVA® therapy should be considered, pending a risk/benefit assessment, on an individual basis.
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Women should be advised not to become pregnant when taking XGEVA® (denosumab). If the patient is pregnant or becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
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The most common adverse reactions in patients receiving XGEVA® (denosumab) 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.
