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Prolia
denosumab
Black Box Warnings .
Severe Hypocalcemia in Advanced CKD Pts
pts w/ advanced CKD (eGFR <30), incl. dialysis-dependent pts, at higher risk of severe hypocalcemia; severe cases resulting in hospitalization, life-threatening events, and death have occurred; CKD-mineral bone disorder (CKD-MBD) markedly incr. risk; eval. for CKD-MBD in pts w/ advanced CKD before tx start; tx in these pts should be supervised by provider w/ expertise in CKD-MBD
Adult Dosing .
Dosage forms: INJ (pre-filled syringe): 60 mg per mL
osteoporosis, postmenopausal
- [60 mg SC q6mo]
- Info: for pts w/ high fracture risk; calcium and vitamin D supplementation required; reassess need for tx in 5-10y; transition to other antiresorptive tx if denosumab D/C
osteoporosis, male
- [60 mg SC q6mo]
- Info: for pts w/ high fracture risk; calcium and vitamin D supplementation required; transition to other antiresorptive tx if denosumab D/C
osteoporosis, steroid-induced
- [60 mg SC q6mo]
- Info: for pts w/ anticipated use of >2.5 mg/day prednisone or equivalent >3mo and incr. fracture risk; refer to ACR guidelines; calcium and vitamin D supplementation required; transition to other antiresorptive tx if denosumab D/C
bone loss, cancer tx-induced
- [60 mg SC q6mo]
- Info: for pts at high fracture risk receiving androgen deprivation tx for nonmetastatic prostate CA or adjuvant aromatase inhibitor tx for breast CA; calcium and vitamin D supplementation required; transition to other antiresorptive tx if denosumab D/C
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.