1. Indications and Usage
\nOsteoporosis (Prolia): Treatment of postmenopausal women with osteoporosis at high risk for fracture; treatment of men with osteoporosis at high risk for fracture.
\nBone Metastases (Xgeva): Prevention of skeletal-related events (SREs) in patients with multiple myeloma or solid tumors with bone metastases.
\nGiant Cell Tumor of Bone (Xgeva): Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
\nSkeletal Reduction: Reduction in bone loss in men receiving androgen deprivation therapy for non-metastatic prostate cancer; reduction in bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer.
\n2. Dosage and Administration
\nRoute of Administration:
\nFor Subcutaneous Injection ONLY (thigh, upper arm, or lower abdomen).
\nRecommended Dosage:
\nOsteoporosis (60 mg): 60 mg administered once every 6 months.
\nBone Metastases & Giant Cell Tumor (120 mg): 120 mg administered once every 4 weeks.
\nSupplementation:
\nAll patients must be supplemented with calcium and vitamin D to prevent hypocalcemia.
\n3. Mechanism of Action
\nRANKL Inhibition:
\nDenosumab is a human IgG2 monoclonal antibody that binds with high affinity and specificity to the Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL).
\nBlocking Signaling:
\nBy binding to RANKL, denosumab prevents it from interacting with its receptor (RANK) on the surface of osteoclast precursors and mature osteoclasts.
\nDownstream Effect:
\nThis inhibition prevents osteoclast formation, function, and survival, thereby reducing bone resorption and increasing bone mass and strength.
\n4. Safety and Warnings
\nHypocalcemia (Boxed Warning):
\nSerious and sometimes fatal hypocalcemia can occur. Risk is highest in patients with severe renal impairment (eGFR <30 mL\/min).
\nRequirement: Correct hypocalcemia and other disturbances of bone and mineral metabolism before dosing.
\nSerious Infections:
\nIncreased risk of serious infections (e.g., cellulitis) has been observed; monitor patients with active infections or those on immunosuppressants.
\nOsteonecrosis of the Jaw (ONJ):
\nCases of ONJ have been reported. Risk factors include invasive dental procedures, cancer, and prolonged use.
\nAtypical Femoral Fractures:
\nRare cases of atypical subtrochanteric and diaphyseal femoral fractures have been reported.
\nRebound Phenomenon:
\nDiscontinuation of denosumab may be associated with multiple vertebral fractures (rebound effect). Alternative therapy should be considered upon discontinuation.
\n5.Adverse Reactions
\nMost Common (Osteoporosis):
\nBack pain, extremity pain, musculoskeletal pain, hypercholesterolemia, and bladder infection.
\nMost Common (Bone Metastases):
\nFatigue, weakness, musculoskeletal pain, diarrhea, nausea, and rash.
\n6.Drug Interactions
\nNo CYP Interaction:
\nAs a biologic molecule, denosumab does not interact with CYP450 enzymes.
\nImmunosuppressants:
\nCaution is advised when used concomitantly with other immunosuppressive therapies (e.g., corticosteroids, rituximab) due to cumulative infection risk.
\n7.Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Denosumab.
\nAvailable Strength:
\nProlia: 60 mg\/1 mL (Prefilled syringe).
\nXgeva: 120 mg\/1.7 mL (Single-dose vial).
\nAppearance: Clear to slightly opalescent, colorless to pale yellow solution.
\nStorage: Store at 2\u00b0C to 8\u00b0C (36\u00b0F to 46\u00b0F).<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name:\u00a0 \u5b89\u52a0\u7ef4 \u00ae(Xgeva\u00ae)
\nGeneric Name: Denosumab
\nStrength: 120 mg\/1.7 mL per vial
\nManufacturer: Amgen Manufacturing Limited
\nMarketing Authorization Holder: Amgen Europe B.V. (Domestic filing entity: Amgen Biopharmaceutical (Shanghai) Co., Ltd.)
\nApproval Date in China: May 21, 2019
\nRegistration Number: \u56fd\u836f\u51c6\u5b57 SJ20190019
\nStorage: Store under refrigeration at 2\u20138\u00b0C (36\u201346\u00b0F). Do not freeze, shake, or expose to direct sunlight. Keep the vial in the original carton to protect from light. Refer to the package insert for detailed handling instructions.<\/p>\n
Price&Cost:Contact Us now for the best price of Denosumab(Xgeva\uff09<\/p>\n","protected":false},"featured_media":4056,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[25],"product_tag":[],"class_list":["post-4055","product","type-product","status-publish","has-post-thumbnail","product_cat-injection","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n