Denosumab-qbdedosage

Pregnancy must be ruled out prior to administration of Enoby. Before initiating Enoby 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. Enoby 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 Enoby Pregnancy must be ruled out prior to administration of Enoby. Perform pregnancy testing in all females of reproductive potential prior to administration of Enoby. 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 Enoby 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 Enoby 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 Enoby should be administered by a healthcare provider. The recommended dose of Enoby is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Enoby 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 Enoby 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. Enoby is a clear to slightly opalescent, colorless to pale yellow solution. Do not use if the solution is discolored or cloudy or if the solution contains particles or foreign particulate matter. Prior to administration, Enoby 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 Enoby in any other way. Instructions for Administration of Enoby Prefilled Syringe with Needle Safety Guard IMPORTANT: In order to minimize accidental needlesticks, the Enoby single-dose prefilled syringe has a clear safety guard that activates automatically to cover the needle after the injection is given. DO NOT attempt to activate the clear safety guard prior to administering the injection; it will lock in place and prevent injection.

Step 1: Remove Gray Needle Cap (Figure A) Figure A Step 2: Administer Subcutaneous Injection Choose an injection site (Figure B). The recommended injection sites for Enoby include: the upper arm OR the upper thigh OR the abdomen. Do not press the plunger while inserting the needle. Figure B Do not administer into muscle or blood vessel. Pinch the skin and insert at a 45 to 90-degree angle. Push the plunger with slow and constant pressure all the way down until you feel or hear a “snap” (Figure C).

Figure C Step 3: Release Plunger and Dispose of Syringe Keeping the prefilled syringe at the injection site, release the thumb from the plunger and lift syringe. The syringe safety guard will automatically cover the injection needle (Figure D). Figure D Immediately dispose of the syringe and needle cap in the nearest sharps container. Do not put the needle cap back on the used syringe. Enoby Before Use Enoby After Use Enoby Figure A Enoby - Figure B Enoby Figure D Enoby Figure E