DCSIMG

Safety Evaluated Across 3 Studies Including More Than 5,600 Patients

Pre-existing hypocalcemia must be corrected prior to initiating therapy with XGEVA®1

  • Monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary1
  • XGEVA® can cause severe symptomatic hypocalcemia, and fatal cases have been reported11

Fewer acute phase reaction events were reported in the Xgeva® arm2,3*

Fewer acute phase reaction events were reported in the XGEVA® arm
  • *Acute phase reaction events occurred within the first 3 days of treatment, and the most common were pyrexia, fatigue, bone pain, arthralgia, and chills.2,3

Xgeva® is a monoclonal antibody and is not cleared by the kidneys;
no dose adjustments are required1,4-8

  • Patients with creatinine clearance < 30 mL/min were excluded from Xgeva® clinical trials

See Xgeva® dosing & administrationLink Arrow
  • 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®.

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

Access support Link Arrow

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. Data on file, Amgen.

  3. 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(16):3082-3092.

  4. 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.

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

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

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

  8. 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.