Latex Allergy: People sensitive to latex should not handle the grey needle cap on the single-use prefilled syringe, which contains dry natural rubber (a derivative of latex).

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-use 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.

The grey needle cap on the single use prefilled syringe contains dry natural rubber (a derivative of latex); people sensitive to latex should not handle the cap.

Step 1: Remove Grey Needle Cap

Remove needle cap. 

Step 2: Administer Injection

Insert needle and inject all the liquid. 

DO NOT put grey 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 plastic 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. 
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.

Instructions for Single-use Vial

For administration of Prolia from the single-use vial, use a 27-gauge needle to withdraw and inject the 1 mL dose. Do not re-enter the vial. Discard vial and any liquid remaining in the vial.

3 DOSAGE FORMS AND STRENGTHS
1 mL of a 60 mg/mL solution in a single-use prefilled syringe
1 mL of a 60 mg/mL solution in a single-use vial

4 CONTRAINDICATIONS

4.1 Hypocalcemia
Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypocalcemia and Mineral Metabolism
Hypocalcemia may be exacerbated by the use of Prolia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia. In patients predisposed to hypocalcemia and disturbances of mineral metabolism (e.g. history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndromes, excisio