Consider treatment interruption until osteonecrosis of the jaw (ONJ) condition resolves & contributing risk factors are mitigated; treatment discontinuation in patients suspected to have atypical femur fracture. ONJ; osteonecrosis external auditory canal. May develop skin infections predominantly cellulitis. Severe symptomatic hypocalcaemia (mostly during 1st wk of initiating therapy). Atypical femoral fractures w/ little or no trauma in subtrochanteric & diaphyseal regions of femur & in patients w/ certain co-morbid conditions (eg, vit D deficiency, RA, hypophosphatasia) & w/ use of certain pharmaceutical agents (eg, bisphosphonates, glucocorticoids, PPIs). Patients w/ long-term glucocorticoid therapy. Delay start of treatment/new treatment course in patients w/ unhealed open soft-tissue lesions in the mouth. Ensure adequate intake of Ca & vit D to correct hypocalcaemia prior to therapy. Clinical monitoring of Ca levels before each dose & in patients predisposed to hypocalcaemia w/in 2 wk after initial dose. Measure Ca levels if any patient presents w/ suspected symptoms of hypocalcaemia during treatment. Perform dental exam w/ preventive dentistry & individual benefit-risk assessment prior to treatment; invasive dental procedures only after careful consideration & be avoided in close proximity to denosumab administration. Evaluate patient's risk of developing ONJ eg, potency of medicinal product, route of administration & cumulative dose of bone resorption therapy, cancer, co-morbid conditions, smoking, concomitant therapies w/ corticosteroids, chemotherapy, angiogenesis inhibitors, RT to head & neck, poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures. Avoid invasive dental procedures & 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. Report new or unusual thigh, hip, or groin pain. Concomitant long-term 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 (or fructose). Severe renal impairment (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 childn <18 yr.
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