Xgeva

Xgeva Injection (Denosumab) is a drug of human monoclonal antibodies (IgG2 isotype) produced on the cell line of mammals using recombinant DNA technology.

Xgeva Injection (Denosumab) prescribed for prevention of bone pathologies in patients with metastatic bone defeat by solid tumors.

Xgeva Injection (Denosumab) is a human monoclonal antibody (IgG2) that targets the RANK ligand and binds to a high affinity and specificity, preventing it from activating its single RANK receptor on the surface of the osteoclasts and their precursors.

The RANK ligand plays an important role in the formation, functioning and survival of osteoclasts, the only type of cells responsible for resorption of bone tissue.

The increased activity of osteoclast, stimulated by the RANK ligand, is a key factor in the destruction of bone tissue in metastatic tumors and multiple myeloma. Interference with the interaction of RANK Ligand with the RANK receptor leads to a decrease in the number of osteoclasts and their function impairment, which reduces resorption and bone tissue destruction as a result of the metastatic process.

Denosumab is slowly distributed in the body after subcutaneous injection, and the maximum concentration of the drug in the blood is reached within 10 days of administration. The drug is metabolized in the reticuloendothelial system.

The half-life of the drug from the body is an average of 26 days, and this time does not change with hepatic and renal failure, as well as in patients of different age groups.

Strictly follow your doctor`s instructions for using Xgeva Injection (Denosumab) to get the most effective results from treatment. The drug should be used by persons who have proper injection technique.

The recommended dose of the Xgeva Injection (Denosumab) is 120 mg in the form of subcutaneous injection once every 4 weeks in the thigh, abdomen, or shoulder surface.

Patients should be given enough calcium and vitamin D during treatment.

Denosumab is slowly distributed in the body after subcutaneous injection, and the maximum concentration of the drug in the blood is reached within 10 days of administration. The bioavailability of denosumab is 61%. The drug is metabolized in the reticuloendothelial system.

The use of denosumab may cause side effects including:

• Dyspnea
• Nausea
• Hypophosphatemia
• Hypocalcemia
• Hypersensitivity to the drug
• Osteonecrosis of the jaw
• Atypical bone fractures

Interaction studies with other drugs have not been conducted for the Xgeva Injection (Denosumab).

In clinical trials, the Xgeva Injection (Denosumab) was used in combination with anticancer drugs and in patients who previously received bisphosphonates. The pharmacokinetics and pharmacodynamics of denosamub did not change as a result of concomitant chemotherapy and / or hormonal therapy or prior intravenous administration of bisphosphonates.

This medicinal product can not be mixed with other medical products.