• Denomab<sup>®</sup>

Denomab®

Denosumab

Description
Denosumab is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL. Denosumab binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Denosumab 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 in both cortical and trabecular bone.

Indications
Denosumab is a RANK ligand (RANKL) inhibitor indicated for:
i. Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture- Denosumab is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures
ii. Treatment to Increase Bone Mass in Men with Osteoporosis- Denosumab is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy
iii. Treatment of Glucocorticoid-Induced Osteoporosis- Denosumab is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy
iv. Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer- Denosumab is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Denosumab also reduced the incidence of vertebral fractures
v. Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer- Denosumab is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
vi. Treatment of Multiple Myeloma and Bone Metastasis from Solid Tumors- Denosumab is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
vii. Treatment of Giant Cell Tumor of Bone- Denosumab is indicated for the 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
viii. Treatment of Hypercalcemia of Malignancy- Denosumab is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy

Supply
Denomab® PFS 60 mg/mL- Each commercial box contains 1 pre-filled syringe.

 

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