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Pregnancy must be ruled out prior to administration of Jubbonti.

Before initiating Jubbonti 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.

Jubbonti 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 Jubbonti Pregnancy must be ruled out prior to administration of Jubbonti. Perform pregnancy testing in all females of reproductive potential prior to administration of Jubbonti. 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 Jubbonti 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 Jubbonti 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 Jubbonti should be administered by a healthcare provider. The recommended dose of Jubbonti is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Jubbonti 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 Jubbonti 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. Jubbonti is a clear to slightly opalescent and colorless to slightly yellowish to slightly brownish 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, Jubbonti 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 Jubbonti in any other way. Instructions for Administration of Prefilled Syringe with Needle Safety Guard

The prefilled syringe has a safety guard that activates to cover the needle after the injection is finished. The safety guard helps to prevent needle stick injuries to anyone who handles the prefilled syringe after injection.

Do not touch the safety guard wings before use. Touching them may cause the safety guard to activate too early. Step 1: Remove Needle Cap Step 2: Administer Subcutaneous Injection Choose an injection site The recommended injection sites for Jubbonti include: upper arm, upper thigh, or the abdomen. Do not press the plunger while inserting the needle. Start injection Pinch the skin and insert the needle. Slowly press the plunger as far as it will go. This will ensure that a full dose is injected. Complete injection Confirm that the plunger head is between the safety guard wings as shown. This will ensure that the safety guard has been activated and will cover the needle after the injection is finished. Release plunger Keeping the prefilled syringe at the injection site, slowly release the plunger until the needle is covered by the safety guard. Remove the prefilled syringe from the injection site and release the pinch. Do not rub the injection site. Immediately dispose of the syringe and needle cap in the nearest sharps container. Do not put the needle cap back on the used syringe. image-1 image2 Image3 Image4 Image5