DCSIMG

Safety Evaluated Across 3 Head-to-Head Phase 3 Studies Including More Than 5,600 Patients

Xgeva® is not cleared by the kidneys and does not require dose adjustments, regardless of renal function1-6

Renal considerations  
  zoledronic acid7 Xgeva®1-6
Cleared by kidneys? Yes No
Dose adjustment required for baseline renal impairment? Yes No
Dose withholding required for declining renal function during therapy? Yes No



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.8

Fewer acute phase reaction events were reported in the XGEVA® arm9*

  zoledronic acid Xgeva®
All events 20.2% 8.7%
Pyrexia 7.2% 0.6%
Fatigue 2.5% 1.7%
Bone pain 2.4% 1.1%
Arthralgia 2.2% 1.1%
Chills 2.0% 0.1%



  • *Acute phase reaction events occurred within the first 3 days of treatment, and the most common were pyrexia, fatigue, bone pain, arthralgia, and chills.9

Supplement with calcium and vitamin D as necessary to prevent or treat hypocalcemia8,10-12

Supplement with calcium and vitamin D as necessary to prevent or treat hypocalcemia Plus Supplement with calcium and vitamin D as necessary to prevent or treat hypocalcemia
  • Help XGEVA® (denosumab) patients by emphasizing the importance of supplementing treatment with calcium ≥ 500 mg and vitamin D ≥ 400 IU daily as necessary to prevent or treat hypocalcemia8,10-12

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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® is contraindicated in patients with clinically significant hypersensitivity to any component of the product. XGEVA® can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Osteonecrosis of the jaw (ONJ) and atypical femoral fracture have been reported. XGEVA® can cause fetal harm when administered to a pregnant woman.

Amgen provides a dedicated specialist with expertise in local coverage and reimbursement policies.

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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

Hypersensitivity Hypocalcemia Osteonecrosis of the Jaw (ONJ) Atypical Subtrochanteric and Diaphyseal Femoral Fracture Pregnancy Adverse Reactions Please see Full Prescribing Information

References

  1. Data on file, 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. Zometa® (zoledronic acid) prescribing information, Novartis Pharmaceuticals Corporation.

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

  9. Data on file, Amgen.

  10. Stopeck AT,Lipton A, Body J-J, et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010;28:5132-5139.

  11. Fizazi K, Carducci M, Smith M, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011;377:813-822.

  12. Henry DH, Costa L, Goldwasser F, et al. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011;29:1125-1132.