Xgeva(Denosumab)
www.xgeva.com
Xgeva is approved for use in patients with metastatic (bony) prostate cancer. It is an injection given monthly with a low risk of side effects. It has been proven superior to Zometa in terms of preventing SRE’s and perhaps at reducing the risk of metastatic bone disease.
Denosumab is a fully human monoclonal antibody directed at RANK ligand that regulates osteoclast function. Administration of Denosumab 60 mg monthly an antibody injected monthly which blocks a signal that allows bone loss to occur.
Calcium 1200 mg and Vitamin D 1000 IU are strongly recommended for patients treated with Xgeva.
Risks include a rare increased risk of osteonecrosis of the jaw (ONJ). 80% of patients with ONJ had previous dental procedures, poor hygeine or wear a dental appliance. The risk of ONJ is slightly higher in Xgeva versus Zometa.
Comparison of agents for bone metastasis
Denosumab was compared to zoledronic acid in a randomized, double- blind,placebo-controlled study in men with CRPC. The absolute incidence of SREs was similar in the 2 groups; however, the median time to first SRE was delayed by 3.6 months by denosumab compared to zoledronic acid (20.7 vs. 17.1 months) The rates of important SREs with denosumab were similar to zoledronic acid and included spinal cord compression (3% vs. 4%), need for radiation (19% vs. 21%), and pathologic fracture (14% vs. 15%).
Treatment-related toxicities reported for zoledronic acid and denosumab were similar and included hypocalcemia (more common with denosumab 13% vs. 6%), arthralgias, and osteonecrosis of the jaw (ONJ, 1%–2% incidence). The most common side effects are minor flu-like symptoms and occasionally some mild Gastrointestinal problems constipation, nausea, vomiting or loss of appetite.
Care should be given to patients with kidney disease.
The most devastating adverse events is osteonecrosis of the jaw(ONJ). This problem occurs when an upper or lower area of the teeth or jaw becomes infected and this infection becomes difficult to cure while on these drugs. One way to decrease the risk of this problem is to get dental clearance prior to starting therapy.
The majority of cases of ONJ are in patients who have been treated for a longer duration and commonly have had a previous dental procedure. If you have any of the following symptoms be sure to mention it to your provider.
*Mouth or facial pain that resemble a toothache
*Chronic sinusitis (inflammation of the sinuses)
*Foul smelling drainage in the jaw area
*Numbness in either the upper or lower jaw
*An exposed bony area inside of the mouth seen on examination