Promptly inject ZILRETTA after preparation to avoid settling of the suspension. If needed, the ZILRETTA suspension can be stored in the vial for up to 4 hours at ambient conditions. Gently swirl the vial to resuspend any of the settled microspheres prior to preparing the syringe for injection. 

The usual technique for intra-articular injection should be followed. Aspiration of synovial fluid may be performed based on clinical judgment prior to administration of ZILRETTA. 

2.3 Non-Interchangeability with Other Formulations of Triamcinolone Acetonide for Intra-articular Use 

ZILRETTA is not interchangeable with other formulations of injectable triamcinolone acetonide. 

3 DOSAGE FORMS AND STRENGTHS

ZILRETTA is an injectable suspension that delivers 32 mg of triamcinolone acetonide. ZILRETTA is supplied as a single-dose kit, containing: 

One vial of ZILRETTA white to off-white microsphere powder 

One vial of 5 mL sterile, clear diluent 

One sterile vial adapter 

4 CONTRAINDICATIONS

ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product [see Warnings and Precautions ( 5.3) and How Supplied/Storage and Handling ( 16)] . 

5 WARNINGS AND PRECAUTIONS

5.1 Warnings and Precautions Specific for ZILRETTA 

ZILRETTA has not been eva luated and should not be administered by the following routes: 

Epidural 

Intrathecal 

Intravenous 

Intraocular 

Intramuscular 

Intradermal 

Subcutaneous 

[see Warnings and Precautions ( 5.2)].  

5.2 Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration 

Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke [see Adverse Reactions ( 6)] . These serious neurologic events have been reported with and without use of fluoroscopy. 

Reports of serious medical events have been associated with the intrathecal route of corticosteroid administration [see Adverse Reactions ( 6)] . 

The safety and effectiveness of epidural and intrathecal administration of corticosteroids have not been established, and corticosteroids are not approved for this use. In particular, the formulation of ZILRETTA should not be considered safe to use for epidural or intrathecal administration. 

5.3 Hypersensitivity Reactions 

Rare instances of anaphylaxis have occurred in patients with hypersensitivity to corticosteroids. Cases of serious anaphylaxis, including death, have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration [see Adverse Reactions ( 6)] . Institute appropriate care upon occurrence of an anaphylactic reaction. 

5.4 Joint Infection and Damage