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

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

  • Patients with creatinine clearance < 30 mL/min were excluded from XGEVA® pivotal trials1
  • 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 based on baseline creatinine clearance
    • 10% of patients (n = 277) required dose withholding due to increased serum creatinine during therapy

Studies in patients with renal impairment

Two clinical trials were conducted in patients without cancer and with varying degrees of renal function1

  • In one study, patients (N=55) with varying degrees of renal function (ranging from normal through endstage renal disease requiring dialysis) received a single 60 mg subcutaneous dose of denosumab.
  • In a second study, patients (N=32) with severe renal dysfunction (creatinine clearance less than 30 mL/minute and/or on dialysis) were given two 120 mg subcutaneous doses of denosumab.

In both studies, greater risk of developing hypocalcemia was observed with increasing renal impairment, and with inadequate/no calcium supplementation. In the second study, hypocalcemia was mild to moderate in severity in 96% of patients.1

Monitor calcium levels, and calcium and vitamin D intake1.

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 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.