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Indication

Xgeva^® is indicated for the prevention of skeletal-related events (SREs) 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

• Hypocalcemia: Xgeva^® can cause severe hypocalcemia. 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.
• Osteonecrosis of the Jaw (ONJ): Osteonecrosis of the jaw (ONJ) can occur 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.
  • 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^®.
  • 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.
• Adverse Reactions: The most common adverse reactions in patients receiving Xgeva^® were fatigue/asthenia, hypophosphatemia, and nausea.
  • The most common serious adverse reaction in patients receiving Xgeva^® was dyspnea.
  • The most common adverse reactions resulting in discontinuation of Xgeva^® were osteonecrosis and hypocalcemia.

References

1. Xgeva^® (denosumab) prescribing information, Amgen.
2. Roodman GD. Mechanisms of bone metastasis. N Engl J Med. 2004;350:1655-1664
3. Mundy GR.Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer. 2002;2:584-593.
4. Lipton A, Siena S, Rader M, et al. Comparison of denosumab versus zoledronic acid (ZA) for treatment of bone metastases in advanced cancer patients: an integrated Analysis of 3 pivotal trials. Ann Oncol.2010;21(suppl 8):380. Abstract 1249P. Poster presented at: 35^th Congress of the European Society of Medical Oncology;  October 2010; Milan , Italy.
5. Data on file, Amgen.