Dosing and Administration

No dose adjustment necessary in patients with renal impairment; however, adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis. In clinical studies, patients with severe renal impairment (creatine clearance <30 mL/min) or receiving dialysis were at greater risk of developing hypocalcemia.¹

Adequate intake of calcium and vitamin D is important in all Prolia patients.¹

Pregnancy must be ruled out prior to administration of Prolia. Pregnancy testing should be preformed in all women of reproduction potential prior to Prolia administration. Based on findings in animals, PROLIA may cause fetal harm when administered to pregnant women.¹

Inhibition of bone remodeling is reversible upon discontinuation.^1*

Patients treated with Prolia showed normal architecture and quality on histologic assessment and no evidence of mineralization defects, woven bone or marrow fibrosis.¹