Remove Needle. 

Remove the needle from the syringe containing diluent. 

Attach Diluent Syringe. 

Attach the syringe onto the vial adapter by pushing down and turning clockwise until you feel resistance ( Fig. 8). 

Figure 8 

Figure 8 

Transfer Diluent. 

Slowly and completely push down the syringe plunger to transfer the diluent into the ZILRETTA powder vial ( Fig. 9). 

Note: Equalize the pressure in the syringe by slowly pulling back the plunger to the 5 mL mark. Ensure that no solution is drawn back into the syringe at this stage. 

Figure 9 

Figure 9 

Mix Diluent and Powder ( Fig. 10).  

With the syringe still attached to the ZILRETTA powder vial, hold the syringe and vial at a slight angle. Tap the bottom edge of the vial firmly and repeatedly, in a circular motion, on the padded surface. 

Swirl gently every five or six taps. 

Tap for at least one minute until all powder is completely dispersed. 

Note: Avoid vigorous shaking of the vial to minimize foaming. 

Note: At least one minute of tapping and gentle swirling is required to achieve uniform suspension. 

Figure 10 

Figure 10 

Inspect Vial. 

Inspect the ZILRETTA powder vial to ensure no clumped powder is visible and a uniform suspension has been achieved. A properly mixed suspension will be milky white, contain no clumps, and move freely down the vial wall. 

As shown in Figure 11, the vial on the left, with the X, requires more tapping and gentle swirling because the powder is not mixed properly with the diluent. The vial on the right shows the powder properly mixed and ready for the next step. 

Figure 11 

Figure 11 

Note: If needed, the ZILRETTA suspension can be stored in the vial for up to 4 hours at ambient conditions. The syringe must remain on the vial adapter while the suspension remains in the vial. 

Withdraw Contents into Syringe. 

Swirl the vial gently for at least 10 seconds to ensure the powder is fully suspended. Immediately depress the plunger fully and then invert the syringe so the vial is directly on top of the syringe ( Fig. 12). 

Hold the syringe in a completely vertical position, per the illustration on the right, in Figure 12. 

Withdraw the full contents from the ZILRETTA vial into the syringe. 

Figure 12 

Figure 12 

Note: ZILRETTA is a suspension product and it is normal for some residue to be left behind on the vial walls after withdrawing the contents. 

Remove Syringe. 

Remove the syringe from the vial adapter by turning counter-clockwise. 

Remove Air Bubbles. 

Attach a new needle to the syringe and remove the needle guard. 

Inspect for bubbles with the syringe held in a completely vertical position (needle upward). If bubbles are observed, gently tap the syringe with your finger until the bubbles rise to the top. Eliminate all bubbles by slowly depressing the plunger to displace the air from the syringe. 

Replace the needle guard. 

Attach New Needle. 

Remove and discard the needle. 

Attach a new needle. 

4. Administration 

Invert Syringe.