for the prevention of skeletal-related events in adult patients with bone metastases from solid tumors.
藥理
Denosumab binds to RANKL(是一種對蝕骨細胞之形成、功能與存活極為重要的穿膜蛋白或可溶性蛋白), a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Prolia prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength.
藥動學
Bioavailability, SubQ: 62%; Elimination Half Life: 25.3- 28 days; Onset of action: Decreases markers of bone resorption by ~85% within 3 days; maximal reductions observed within 1 month; Duration: Markers of bone resorption return to baseline within 12 months of discontinuing therapy.
禁忌症
Hypersensitivity to denosumab or any component of the formulation; pre-existing hypocalcemia; pregnancy
懷孕分類
D (Xgeva)/X (Prolia)
哺乳分類
Excretion unknown/not recommended
副作用
Common: back pain, pain in extremity, musculoskeletal pain, Diarrhea, Nausea, Vomiting, Headache, URI, hypercholesterolemia, and cystitis. Serious: Hypocalcemia (1.7% to 18%), Hypophosphatemia, Infectious disease, Aseptic necrosis of bone of jaw, Cancer.
劑量和給藥方法
120 mg administered as a single subcutaneous injection every 4 weeks. Inject in the upper arm, upper thigh, or abdomen.
小兒調整劑量
腎功能調整劑量
肝功能調整劑量
安定性
Store in a refrigerator at 2 and 8 degrees C (36 and 46 degrees F) in the original carton. Do not freeze. Once removed from the refrigerator, Xgeva must not be exposed to temperatures above 25 degrees C (77 degrees F) and must be used within 14 days. If not used within the 14 days
注射給藥指引
給藥途徑
SC
靜脈輸注液
每瓶稀釋液體積
注射濃度
給藥速率
安定性
Store in a refrigerator at 2 and 8 degrees C (36 and 46 degrees F) in the original carton. Do not freeze. Once removed from the refrigerator, Xgeva must not be exposed to temperatures above 25 degrees C (77 degrees F) and must be used within 14 days. If not used within the 14 days