Denosumab

Renal Impairment Two clinical trials were conducted in patients without cancer and with varying degrees of renal function. In one study, patients (N = 55) with varying degrees of renal function (ranging from normal through end-stage renal disease requiring dialysis) received a single 60 mg subcutaneous dose of denosumab.

In a second study, patients (N = 32) with severe renal dysfunction (creatinine clearance less than 30 mL/min and/or on dialysis) were given two 120 mg subcutaneous doses of denosumab. In both studies, greater risk of developing hypocalcemia was observed with increasing renal impairment, and with inadequate/no calcium supplementation.

Hypocalcemia was mild to moderate in severity in 96% of patients. Monitor calcium levels and calcium and vitamin D intake [see Warnings and Precautions, Adverse Reactions, and Clinical Pharmacology] .

Important Administration Instructions Bilprevda should be administered by a healthcare provider. Bilprevda is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally.

Preparation and Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Bilprevda is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the solution is discolored or cloudy or if the solution contains many particles or foreign particulate matter.

Prior to administration, Bilprevda may be removed from the refrigerator and brought to room temperature up to 25°C (77°F) by standing in the original container. This generally takes 15 to 30 minutes. Do not warm Bilprevda in any other way [see How Supplied/Storage and Handling] . Use a 27-gauge needle to withdraw and inject the entire contents of the vial.

Do not re-enter the vial. Discard vial after single entry.