The ZILRETTA powder vial contains an overfill to allow the appropriate dose to be withdrawn. ZILRETTA is a suspension product and it is normal for some residue to be left behind on the vial walls after withdrawing the contents. 

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. 

Use proper aseptic technique throughout the dose preparation and administration procedure. 

Inspect all kit components to confirm they have not expired and the seals are intact. 

For additional information, visit www.zilretta.com or call Flexion Therapeutics at 1-844-FLEXION (353-9466). 

MATERIALS REQUIRED 

                (Fig.1)  

Supplied 

One 32 mg vial of ZILRETTA microsphere powder 

One 5 mL vial of sterile diluent 

One sterile vial adapter 

Not Supplied 

Three sterile needles, 21-gauge, 1½” length 

One sterile Luer Lock compatible syringe, 5 mL 

Sterile alcohol pads 

Paper towels or pad to cushion vial tapping (not shown in Fig. 1) 

Medical-grade gloves (not shown in Fig. 1) 

Figure 1 

Figure 1 

1. Vial Preparation 

Loosen Powder. 

Place two paper towels or a pad on a properly-cleaned hard surface. 

Grip the top of the ZILRETTA powder vial and tap firmly and repeatedly on the padded surface. Tap the vial until excess powder is dislodged from the vial and stopper ( Fig. 2). Before continuing, ensure that powder moves freely within the vial. 

Figure 2 

Figure 2 

Inspect ZILRETTA Powder Vial. 

As shown in Figure 3, the vial on the left, with the X, requires additional tapping because the powder is not properly dislodged. The vial on the right shows the powder properly dislodged and ready for the next step. 

Figure 3 

Figure 3 

Remove Caps. 

Remove the flip-off caps from the ZILRETTA powder and diluent vials ( Fig. 4). 

Figure 4 

Figure 4 

Clean Vials. 

Clean the ZILRETTA powder and diluent vial tops with an alcohol pad. 

Use a separate alcohol pad for each vial. 

Peel Off Vial Adapter Cover. 

Peel off the paper cover from the vial adapter package ( Fig. 5). 

Leave the adapter in the plastic holder. 

Figure 5 

Figure 5 

Attach Vial Adapter to ZILRETTA Powder Vial. 

Grip the plastic holder that contains the vial adapter. 

As shown in Figure 6, place the ZILRETTA powder vial on a flat surface. In a vertical orientation, gently push the adapter down onto the ZILRETTA powder vial until the spike on the adapter penetrates the rubber stopper on the ZILRETTA powder vial. The adapter will snap into place. 

Figure 6 

Figure 6 

2. Diluent Preparation 

Attach Needle. 

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

Withdraw Diluent. 

With a syringe and needle, withdraw 5 mL of diluent. 

Replace the needle guard. 

3. Dose Preparation 

Remove Holder. 

Remove the plastic holder from the vial adapter ( Fig. 7). 

Figure 7