Drug Detail:Prolia (Denosumab (prolia) [ den-oh-sue-mab ])
Generic Name: DENOSUMAB 60mg in 1mL
Dosage Form: injection
Drug Class: Miscellaneous bone resorption inhibitors
Information Essential to Safe Dosing or Administration
Pregnancy must be ruled out prior to administration of Prolia. Perform pregnancy testing in all females of reproductive potential prior to administration of Prolia. Based on findings in animals, Prolia can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1, 8.3)].
Recommended Dosage
Prolia should be administered by a healthcare professional.
The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Prolia 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 [see Warnings and Precautions (5.3)].
If a dose of Prolia 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.
Preparation and Administration
Visually inspect Prolia for particulate matter and discoloration prior to administration whenever solution and container permit. Prolia is a clear, colorless to pale yellow solution that may contain trace amounts of translucent to white proteinaceous particles. Do not use if the solution is discolored or cloudy or if the solution contains many particles or foreign particulate matter.
Prior to administration, Prolia 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 Prolia in any other way [see How Supplied/Storage and Handling (16)].
Instructions for Prefilled Syringe with Needle Safety Guard
IMPORTANT: In order to minimize accidental needlesticks, the Prolia single-dose prefilled syringe will have a green safety guard; manually activate the safety guard after the injection is given.
DO NOT slide the green safety guard forward over the needle before administering the injection; it will lock in place and prevent injection.
Activate the green safety guard (slide over the needle) after the injection.
Step 1: Remove Gray Needle Cap
| Remove needle cap. |  |
Step 2: Administer Subcutaneous Injection
| Choose an injection site. The recommended injection sites for Prolia include: the upper arm OR the upper thigh OR the abdomen. |  |
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| Insert needle and inject all the liquid subcutaneously. Do not administer into muscle or blood vessel. |
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DO NOT put gray needle cap back on needle.
Step 3: Immediately Slide Green Safety Guard Over Needle
With the needle pointing away from you.
Hold the prefilled syringe by the clear finger grip with one hand. Then, with the other hand, grasp the green safety guard by its base and gently slide it towards the needle until the green safety guard locks securely in place and/or you hear a "click". DO NOT grip the green safety guard too firmly - it will move easily if you hold and slide it gently.
| Hold clear finger grip. |  |
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| Gently slide green safety guard over needle and lock securely in place. Do not grip green safety guard too firmly when sliding over 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.
