Denosumab

Denosumab is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Denosumab is a monoclonal antibody designed to treat bone-related conditions. It works by inhibiting the activity of a protein called RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand), which plays a crucial role in bone breakdown.

Indications

-Treatment of postmenopausal women with osteoporosis at high risk for fracture -Treatment to increase bone mass in men with osteoporosis at high risk for fracture -Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture -Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer -Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

Dosage

-SC; Single-use prefilled syringe containing 60mg in a 1 mL solution. -The typical dose of denosumab for osteoporosis is 60 mg administered subcutaneously every six months. For patients with bone metastases, the recommended dose is 120 mg every four weeks.

Contra-Indications

Hypersensitivity , pregnancy, hypoglycemia

Special Precautions

Paediatric: Safety and efficacy in pediatric patients have not been established. Pregnancy: Advice females of reproductive potential to use effective contraception during treatment and for 5 months after the last dose. Lactation: Data not sufficient Elderly: No overall differences in safety or efficacy were observed between these patients and younger patients.

Side Effects

-Postmenopausal osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, pain in extremities, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. -Male osteoporosis: Most common adverse reactions (>5% and more common than placebo) were: back pain, arthralgia, and nasopharyngitis. -Glucocorticoid-induced osteoporosis: Most common adverse reactions (> 3% and more common than active- control group) were: back pain, hypertension, bronchitis, and headache Bone loss due to hormone ablation for cancer: Most common adverse reactions (? 10% and more common than placebo) were: arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials

Drug Interactions

Denosumab may interact with certain medications, such as anticonvulsants and glucocorticoids, potentially affecting its effectiveness. Close monitoring and dose adjustments may be necessary.