Included in the formulation
Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):VED
АТХ:M.05.B.X Other drugs affecting the mineralization of bones
Pharmacodynamics:The preparation is a human monoclonal antibody to a nuclear factor activator receptor ligand κAT (RANKL), which is located on the surface of osteoclasts and their predecessors. The drug, binding to the ligand, inhibits the activation of the receptor and, as a consequence, inhibits the activation, formation and life span of osteoclasts. Thus, the resorption of bones decreases and the mass and strength of the trabecular and cortical layers of the bone increases.
Pharmacokinetics:The drug is characterized by a nonlinear dose-dependent pharmacokinetics. The drug is administered subcutaneously, and its bioavailability is about 60%, the metabolism and excretion of the drug occur along the immunoglobulin clearance pathway.
Indications:Postmenopausal osteoporosis, loss of bone mass in women who undergo therapy for breast cancer with aromatase inhibitors, bone loss in men who undergo hormone therapy for prostate cancer. Etccomplications from the bone tissue (pathological fractures, bone irradiation, spinal cord compression or bone surgery) in adults with solid tumors metastasizing to the bone.
II.C76-C80.C79.5 Secondary malignant neoplasm of bone and bone marrow
XIII.M80-M85.M81.0 Postmenopausal osteoporosis
XIII.M80-M85.M81.4 Medicinal osteoporosis
Contraindications:Severe untreated hypocalcemia; pregnancy; lactation period; age to 18 years (not recommended for use in pediatrics, since the efficacy and safety of this drug have not been studied in this age group); hypersensitivity to the components of the drug.
Pregnancy and lactation:Category Food and Drug Administration (US Food and Drug Administration) - C. There is no data on the use of the drug during pregnancy. The drug is not recommended for use in pregnant women. Since it is known that potentially denosumab can cause unwanted reactions in infants, it is necessary either to stop breastfeeding, or to cancel the drug.
Dosing and Administration:The injection of the drug requires preliminary training.
The recommended dose of the drug is one subcutaneous injection of 120 mg every 4 weeks to the hip, shoulder or abdominal area.
Side effects:Cataract; ghypocalcemia; zkema; pain in the limbs; hypophosphatemia; hyperhidrosis; osteonecrosis of the jaw; inflammation of the subcutaneous tissue.
Interaction:The drug should not be mixed with other drugs.
Special instructions:During the intake of the drug recommended intake of calcium and vitamin preparations D.
It is necessary to monitor calcium concentrations in patients with severe renal insufficiency.
It is recommended to examine the oral cavity and preventive examination at the dentist before starting therapy in patients at risk of developing osteonecrosis of the jaw. Adequate oral hygiene should be maintained throughout the treatment period with the drug. During treatment, whenever possible, avoid invasive dental procedures.