Temporary treatment interruption until osteonecrosis of jaw (ONJ) condition resolves & contributing risk factors are mitigated. Delay treatment in patients w/ unhealed open soft tissue lesion in the mouth. Consider treatment discontinuation in patients suspected to have atypical femur fracture. May develop skin infections predominantly cellulitis. Osteonecrosis of external auditory canal. Patients at risk for hypocalcaemia. Adequate intake of Ca & vit D. Correct hypocalcaemia before initiating therapy. Clinical monitoring of Ca levels before each dose & in patients predisposed to hypocalcaemia w/in 2 wk after initial dose. Dental exam w/ preventive dentistry prior to treatment in patients w/ concomitant risk factors of ONJ. Maintain good oral hygiene, receive routine dental check-ups, & immediately report any oral symptoms eg, dental mobility, pain or swelling or non-healing of sores or discharge during treatment. Perform invasive dental procedures only after careful consideration & avoid in close proximity to denosumab administration. Report new or unusual thigh, hip, or groin pain. Contains sorbitol; additive effect on concomitantly administered products containing sorbitol (or fructose). Concomitant glucocorticoid treatment (long-term). Not to be treated concomitantly w/ other denosumab-containing medicinal products. Severe renal impairment (GFR/CrCl <30 mL/min) or patients receiving dialysis. Hepatic impairment. Women should not become pregnant during & for at least 5 mth after treatment. Not recommended during pregnancy & in women of child-bearing potential not using contraception. Lactation. Not to be used in paed patients <18 yr.
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