Generic Name and Formulations:
Denosumab 120mg/vial (70mg/mL); soln for SC inj; preservative-free.
Company:
Amgen, Inc.
Indications for XGEVA:
Prevention of skeletal-related events (SRE) in patients with bone metastases from solid tumors. Not for preventing SRE with multiple myeloma.
Adult Dose for XGEVA:
Give by SC inj into upper arm, upper thigh, or abdomen. 120mg once every 4 weeks.
Children's Dose for XGEVA:
Not established (interferes with bone growth and dentition).
Pharmacological Class:
Osteoclast inhibitor (RANKL inhibitor).
Warnings/Precautions:
Correct hypocalcemia before starting; ensure adequate daily calcium, magnesium, and Vit.D intake, esp. in renal impairment (CrCl<30mL/min). Monitor calcium, phosphorus, magnesium levels in susceptible patients (eg, severe renal impairment, receiving dialysis). Monitor for osteonecrosis of the jaw. Perform oral exam and preventive dentistry before and regularly during therapy. Maintain good oral hygiene. Avoid invasive dental procedures during treatment. Pregnancy (Cat.D; avoid). Nursing mothers: avoid (may impair mammary gland development/lactation).
Interactions:
Concomitant drugs that can lower calcium levels; monitor.
Adverse Reactions:
Fatigue, asthenia, hypophosphatemia, nausea, dyspnea, osteonecrosis of jaw, severe hypocalcemia (may be fatal).
Generic Availability:
NO
How Supplied:
Single-use vial (1.7mL)—1
Xgeva Approved for Giant Cell Tumor of the Bone
XGEVA (denosumab) 120mg/1.7mL injection by Amgen The FDA has expanded the use of Xgeva (denosumab; Amgen) to treat adults and adolescents with unresectable giant cell tumor of the bone (GCTB) or when surgery is likely to result in severe morbidity (eg, loss of limbs or joint removal). Xgeva is an osteoclast inhibitor (RANKL inhibitor) that works by binding to RANKL, a protein essential for maintenance of healthy bone.
RELATED: Musculoskeletal Disorders Resource Center
The FDA reviewed Xgeva under its priority review program and it was later granted orphan product designation. The safety and effectiveness for Xgeva in GCTB were established in two trials that enrolled a total of 305 adult or adolescent patients.
Out of the total 187 patients whose tumors could be measured, 47 patients had their tumors reduce in size after an average of three months. Over an average follow-up of 20 months, re-growth of GCTB occurred in three patients whose tumors originally became smaller during treatment.
Xgeva is already approved for the prevention of skeletal-related events (SRE) in patients with bone metastases from solid tumors. It is not approved for preventing SRE with multiple myeloma.
sBLA Submitted for Xgeva for Expanded Indication
Amgen announced the submission of a supplemental Biologics License Application (sBLA) to the FDA to expand the indication for Xgeva (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. The sBLA submission is based on a pivotal Phase 3 Study ('147) eva luating Xgeva vs. placebo in 1,432 men with castrate-resistant prostate cancer. Results of the '147 study demonstrated that Xgeva significantly prolonged bone metastasis-free survival by more than four months compared with placebo (29.5 vs. 25.2 months, respectively) in men with castrate-resistant prostate cancer that had not yet spread to the bone. If approved, Xgeva would be the first therapy licensed to prevent or delay the spread of cancer to the bone.
Xgeva is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and survival of osteoclasts. Xgeva prevents RANK Ligand from activating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction.
