Increases bone mineral density & reduces incidence of hip, vertebral & non-vertebral fractures in postmenopausal women w/ osteoporosis at increased risk of fracture. Bone loss in patients undergoing hormone ablation for prostate or aromatase inhibitor treatment for breast cancer. Reduces incidence of vertebral fractures in patients w/ prostate cancer. Increases bone mass in men w/ osteoporosis at increased risk of fracture. Glucocorticoid-induced osteoporosis in men & women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in daily dosage equiv to prednisone ≥7.5 mg & expected to remain on glucocorticoid for at least 6 mth.
Osteonecrosis of the jaw & external auditory canal. Skin infections (predominantly cellulitis) leading to hospitalisation. Atypical femoral fractures. Multiple vertebral fractures following discontinuation of treatment. Ensure adequate intake of Ca & vit D to correct hypocalcaemia prior to therapy. Perform dental exam w/ preventive dentistry prior to treatment. Avoid invasive dental procedures & maintain good oral hygiene during treatment. Long-term systemic glucocorticoid therapy; antiresorptive treatment. Not to be used concomitantly w/ other denosumab-containing medicinal products. Concomitant use w/ other sorbitol-containing medicinal products & dietary intake of sorbitol. Severe renal impairment (CrCl <30 mL/min) or patients receiving dialysis. Hepatic impairment. Women of childbearing potential should use effective contraception during & for at least 5 mth after last dose. Not recommended during pregnancy. Lactation. Not to be used in childn <18 yr.
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 60 mg_mLd35048de-8812-4dcf-9c96-a08600d5e04a.GIF)
