Kit Contents   

ZILRETTA microsphere powder  NDC 70801-001-01  5 mL single-dose vial to deliver 32 mg of triamcinolone acetonide supplied as a sterile, white to off-white powder in a cerium glass (clear) vial with a rubber stopper and an aluminum seal with a gray plastic cap.  

Diluent  NDC 70801-002-01  5 mL single-dose vial supplied as a sterile, clear liquid solution of 0.9% w/w sodium chloride (normal saline) containing 0.5% w/w sodium carboxymethylcellulose, and 0.1% w/w polysorbate-80 in a glass vial with a rubber stopper, aluminum seal and white plastic cap.  

Sterile vial adapter  

STORAGE 

To maintain expiry period, refrigerate the ZILRETTA single-dose kit (36°-46°F; 2°-8°C) before use. 

If refrigeration is unavailable, store the ZILRETTA single-dose kit in the sealed, unopened kit at temperatures not exceeding 77°F (25°C) for up to six weeks and then discard. Do not expose the ZILRETTA single-dose kit to temperatures above 77°F (25°C). 

Do not freeze. Store vials in carton. 

17 PATIENT COUNSELING INFORMATION

Increased Risk of Infections 

Inform patients that they may be more likely to develop infections when taking corticosteroids. Instruct patients to contact their health care provider if they develop fever or other signs or symptoms of infection. 

Advise patients who have not been vaccinated to avoid exposure to chicken pox or measles. Instruct patients to contact their health care provider immediately if they are exposed [see Warnings and Precautions ( 5.5)] . 

Risk of Drug Interactions 

There are a number of medicines that can interact with corticosteroids such as triamcinolone acetonide. Advise patients to alert their health care provider(s) to assess the need to adjust their medication(s) [see Drug Interactions ( 7)] . 

Risk of Adverse Psychiatric Reactions 

Inform patients that corticosteroid use may be associated with adverse psychiatric reactions. Advise patients and/or caregivers to immediately report any new or worsening behavioral or mood disturbances to their health care provider [see Warnings and Precautions ( 5.12)] . 

Manufactured for Flexion Therapeutics, Inc., 10 Mall Rd, Suite 301, Burlington, MA 01803 

ZILRETTA and Flexion are trademarks of Flexion Therapeutics, Inc. 

Copyright © 2017 Flexion Therapeutics, Inc. All rights reserved. 

For more information, go to ZILRETTA.com or call 1-844-FLEXION (353-9466). 

Part Number: 60-004-01 

Version: 1, 10/2017  

INSTRUCTIONS FOR USE

Instructions for Use 

ZILRETTA™  

(triamcinolone acetonide 

extended-release injectable suspension)  

For intra-articular injection only 

Single-dose device 

Do not reuse. 

IMPORTANT INFORMATION 

ZILRETTA must be prepared using only the diluent supplied in the kit. 

To ensure proper dosing, it is important that you follow the preparation and administration steps outlined in these instructions. 

Promptly inject ZILRETTA after preparation to avoid settling of the suspension.