Surgical DeviceClinical Overview
Denosumab Injection (60mg/ml pre-filled syringe) is a fully human IgG2 monoclonal antibody on the WHO Model List of Essential Medicines that specifically targets and binds to the Receptor Activator of Nuclear Factor-Kappa B Ligand (RANKL). By neutralizing RANKL, it prevents RANKL from binding to its receptor RANK on osteoclast precursors and mature osteoclasts, halting osteoclast formation, function, and survival. This profoundly shuts down bone resorption throughout cortical and trabecular bone, rapidly increasing bone mineral density. Indicated for treatment of postmenopausal osteoporosis at high risk of fracture, osteoporosis in men, bone loss associated with hormone ablation therapy for breast or prostate cancer, and glucocorticoid-induced osteoporosis.
Active Pharmaceutical Ingredients
Verified Clinical References
Usage Guidelines
Administer by SUBCUTANEOUS (SC) injection only (60 mg once every 6 months) into the upper arm, upper thigh, or abdomen by a healthcare professional. All patients MUST receive daily calcium (at least 1000 mg) and vitamin D (at least 400-800 IU) supplementation to prevent severe hypocalcemia. NEVER interrupt or delay doses without initiating alternative antiresorptive therapy.
General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.
Possible Side Effects
Common: Back pain, pain in extremities, musculoskeletal pain, hypercholesterolemia, cystitis, nasopharyngitis. Rare/Severe: Severe hypocalcemia (especially in CKD patients), Osteonecrosis of the Jaw (ONJ), atypical subtrochanteric femoral fractures, serious infections (cellulitis), and rebound multiple vertebral fractures upon drug discontinuation.
*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.
Precautions & Warnings
Black Box Warning: Severe, potentially fatal hypocalcemia in patients with advanced chronic kidney disease (CKD stage 4-5/dialysis); check calcium levels prior to each dose and correct hypocalcemia. CRITICAL REBOUND PHENOMENON: Discontinuing or delaying denosumab causes a rapid, massive rebound in bone resorption (bone turnover surge), resulting in rapid bone loss and multiple spontaneous vertebral fractures; transition to an IV bisphosphonate (zoledronic acid) is mandatory if denosumab is stopped. Dental exam recommended prior to therapy.
Schedule H (Prescription Required)
This medication is scheduled under statutory drug regulatory frameworks (CDSCO / Drugs & Cosmetics Rules). Dispensing requires a valid medical prescription from a registered medical practitioner. Self-medication or unsupervised dosage adjustment carries significant clinical risks.
Medical Disclaimer: Statutory Clinical Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice, clinical diagnosis, or analgesic treatment guidance. Always consult a registered physician or orthopedic specialist before taking pain relievers, anti-inflammatory medications, or anti-arthritic therapies.