DCSIMG

Xgeva®: A single, subcutaneous injection once every 4 weeks

XGEVA® product

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

Dosing considerations

  • Xgeva® is a monoclonal antibody and is not cleared by the kidneys; no dose adjustments are required1-6
    • Patients with creatinine clearance
      < 30 mL/min were excluded from XGEVA® clinical trials

Dose adjustments/withholdings in head-to-head phase 3 studies of XGEVA® vs zoledronic acid

  • Xgeva® (n = 2,862)7
    • No dose adjustments or dose withholdings were required due to renal function
  • Zoledronic acid arm (n = 2,861)7
    • 18% of patients (n = 502) required dose adjustments for baseline creatinine clearance
    • 10% of patients (n = 277) required dose withholding due to increased serum creatinine during therapy

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
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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

XGEVA® (denosumab) is contraindicated in patients with pre-existing hypocalcemia and clinically significant hypersensitivity to XGEVA®. XGEVA® can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Osteonecrosis of the jaw and atypical femoral fracture have been reported. XGEVA® can cause fetal harm. Females of reproductive potential should use highly effective contraception during therapy, and for at least 5 months after the last dose of XGEVA®.

Xgeva® was evaluated in 3 head-to-head studies including more than 50 solid tumor types.

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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

Hypocalcemia Hypersensitivity Drug Products with Same Active Ingredient Osteonecrosis of the Jaw (ONJ) Atypical Subtrochanteric and Diaphyseal Femoral Fracture Embryo-Fetal Toxicity Adverse Reactions Please see Full Prescribing Information

References

  1. Xgeva® (denosumab) prescribing information, Amgen.

  2. Bekker PJ, Holloway DL, Rasmussen AS, et al. A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res. 2004;19:1059-1066.

  3. Lewiecki EM. Denosumab: an investigational drug for the management of postmenopausal osteoporosis. Biologics. 2008;2:645-653.

  4. Keizer RJ, Huitema ADR, Schellens JHM, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49:493-507.

  5. Mould DR, Green B. Pharmacokinetics and pharmacodynamics of monoclonal antibodies: concepts and lessons for drug development. BioDrugs. 2010;24:23-39.

  6. Sutjandra L, Rodriguez RD, Doshi S, et al. Population pharmacokinetic meta-analysis of denosumab in healthy subjects and postmenopausal women with osteopenia or osteoporosis. Clin Pharmacokinet. 2011;50:793-807.

  7. Lipton A, Fizazi K, Stopeck AT, et al. Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomised, phase 3 trials. Eur J Cancer. 2012;48:3082-3092.