Patients w/ comorbid conditions (eg, vit D deficiency, RA, hypophosphatasia), & concomitant use w/ bisphosphonates, glucocorticoids, PPIs. Multiple vertebral fractures may occur after discontinuation especially in patients w/ risk factors eg, osteoporosis or prior fractures. Correct preexisting hypocalcemia prior to therapy initiation. Ca & vit D supplementation is required in all patients. Monitor Ca levels during treatment, especially in the 1st wk of therapy. Perform dental exam w/ appropriate preventive dentistry prior to treatment, especially in patients w/ risk factors for osteonecrosis of the jaw (ONJ); good oral hygiene during therapy. Avoid invasive dental procedures during treatment. Consider temporary interruption of treatment in patients who are suspected or develops ONJ during treatment. Evaluate patients presenting new or unusual thigh, hip, or groin pain for an incomplete femoral fracture & examine contralateral femur. Monitor for signs & symptoms of hypercalcemia, consider periodic assessment of serum Ca & re-evaluate Ca & vit D supplementation requirements after treatment discontinuation. Not to be used concomitantly w/ other denosumab-containing products (Prolia). Severe renal impairment or receiving dialysis (monitor Ca levels & adequate intake of Ca & vit D). Women should not become pregnant during & for at least 5 mth after treatment. Not recommended in pregnancy. Lactation. Not recommended in ped patients 12-17 yr (other than skeletally mature ped patients w/ giant cell tumor of bone).
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