Not recommended in patients w/ growing skeletons. Ensure adequate intake of Ca & Vit D to correct hypocalcemia prior to therapy. Osteonecrosis of the jaw (ONJ) & external auditory canal. Atypical femoral & multiple vertebral fractures. Multiple vertebral fractures following discontinuation of treatment. Perform oral & dental exam w/ preventive dentistry prior to treatment. Avoid invasive dental procedures & maintain good oral hygiene during treatment. Monitor Ca level in patients w/ risk factors for hypocalcaemia. Not to be used concomitantly w/ other denosumab-containing products & bisphosphonates. Fructose intolerance. Severe renal impairment (CrCl <30 mL/min) or dialysis patients. 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 recommended in paed <18 yr.