5.1 Warnings and Precautions Specific for ZILRETTA  

5.2 Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration  

5.3 Hypersensitivity Reactions  

5.4 Joint Infection and Damage  

5.5 Increased Risk of Infections  

5.6 Alterations in Endocrine Function  

5.7 Cardiovascular Effects  

5.8 Renal Effects  

5.9 Increased Intraocular Pressure  

5.10 Gastrointestinal Perforation  

5.11 Alterations in Bone Density  

5.12 Behavioral and Mood Disturbances  

6 ADVERSE REACTIONS  

7 DRUG INTERACTIONS  

8 USE IN SPECIFIC POPULATIONS  

8.1 Pregnancy  

8.2 Lactation  

8.3 Females and Males of Reproductive Potential  

8.4 Pediatric Use  

8.5 Geriatric Use  

11 DESCRIPTION  

12 CLINICAL PHARMACOLOGY  

12.1 Mechanism of Action  

12.2 Pharmacodynamics  

12.3 Pharmacokinetics  

13 NONCLINICAL TOXICOLOGY  

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility  

14 CLINICAL STUDIES  

16 HOW SUPPLIED/STORAGE AND HANDLING  

17 PATIENT COUNSELING INFORMATION  

* Sections or subsections omitted from the full prescribing information are not listed. Close 

1 INDICATIONS AND USAGE

ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. 

Limitation of Use 

ZILRETTA is not intended for repeat administration [see Dosage and Administration ( 2.1)] . 

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Information 

 ZILRETTA is administered as a single intra-articular extended-release injection of triamcinolone acetonide, to deliver 32 mg (5 mL). 

ZILRETTA is for intra-articular use only and should not be administered by the following routes: epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, subcutaneous. 

ZILRETTA is not suitable for use in small joints, such as the hand. 

The efficacy and safety of repeat administration of ZILRETTA for the management of osteoarthritis pain of the knee have not been eva luated. 

The ef

2.2 Preparation and Administration of Intra-Articular Suspension 

Refer to the Instructions for Use for directions on the preparation and administration of ZILRETTA.  

ZILRETTA is supplied as a single-dose kit containing a vial of ZILRETTA microsphere powder, a vial of sterile diluent, and a sterile vial adapter. 

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

Preparation of ZILRETTA requires close attention to the Instructions for Use to ensure successful administration. 

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