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Pregnancy must be ruled out prior to administration of Bildyos. Before initiating Bildyos in patients with advanced chronic kidney disease, including dialysis patients, evaluate for the presence of chronic kidney disease mineral and bone disorder with intact parathyroid hormone, serum calcium, 25(OH) vitamin D, and 1,25 (OH) 2 vitamin D. Bildyos should be administered by a healthcare provider. Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen. Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily.

2.1 Pregnancy

Testing Prior to Initiation of Bildyos Pregnancy must be ruled out prior to administration of Bildyos. Perform pregnancy testing in all females of reproductive potential prior to administration of Bildyos. Based on findings in animals, denosumab products can cause fetal harm when administered to pregnant women.

2.2 Laboratory

Testing in Patients with Advanced Chronic Kidney Disease Prior to Initiation of Bildyos In patients with advanced chronic kidney disease [i.e., estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m 2 ], including dialysis-dependent patients, evaluate for the presence of chronic kidney disease mineral and bone disorder (CKD-MBD) with intact parathyroid hormone (iPTH), serum calcium, 25(OH) vitamin D, and 1,25 (OH) 2 vitamin D prior to decisions regarding Bildyos treatment. Consider also assessing bone turnover status (serum markers of bone turnover or bone biopsy) to evaluate the underlying bone disease that may be present.

2.3 Recommended

Dosage Bildyos should be administered by a healthcare provider. The recommended dose of Bildyos is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Bildyos via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily. If a dose of Bildyos is missed, administer the injection as soon as the patient is available. Thereafter, schedule injections every 6 months from the date of the last injection.

2.4 Preparation and

Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Bildyos is clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the solution is discolored or cloudy or if the solution contains visible particles or foreign particulate matter. Prior to administration, Bildyos 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 Bildyos in any other way. Instructions for Administration of Bildyos Prefilled Syringe with Needle Safety Guard

Bildyos single-dose prefilled syringe contains a safety guard that activates to cover the needle after the injection is finished. The safety guard helps to prevent needlesticks. Step 1: Remove Needle Cap Carefully pull the black needle cap straight out and away from your body. Step 2: Administer Subcutaneous Injection Choose an injection site. The recommended injection sites for Bildyos include the upper arm, OR the upper thigh, OR the abdomen. Pinch your injection site to create a firm surface. Hold the pinch. Insert the needle into the skin at 45 to 90 degrees. Push the plunger with slow and constant pressure until you feel or hear a “snap”. Push all the way down through the snap. Release your thumb. Then lift the syringe off skin. After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle. Immediately dispose of the syringe and needle cap in the nearest sharps container. Do not put the needle cap back on the used syringe. Figure 1 Figure 2 Figure 3 Figure 4 Figure 5