HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ZILRETTA safely and effectively. See full prescribing information for ZILRETTA. 

 ZILRETTA™ (triamcinolone acetonide extended-release injectable suspension), for intra-articular use 

 Initial U.S. Approval: 1957 

INDICATIONS AND USAGE 

ZILRETTA is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. ( 1) 

Limitation of Use 

ZILRETTA is not intended for repeat administration. ( 1) 

DOSAGE AND ADMINISTRATION 

32 mg administered as a single intra-articular injection in the knee. ( 2.1) 

See Instructions for Use (IFU) for instructions on reconstitution of ZILRETTA with the supplied diluent. ( 2.2) 

It is normal for some residue to be left behind on the vial walls after withdrawing the suspension. ( 2.2) 

Not interchangeable with other formulations of injectable triamcinolone acetonide. ( 2.3) 

DOSAGE FORMS AND STRENGTHS 

ZILRETTA is an injectable suspension that delivers 32 mg of triamcinolone acetonide. It is supplied as a single-dose kit containing one vial of ZILRETTA microsphere powder, one vial of 5 mL diluent, and one sterile vial adapter. ( 3) 

CONTRAINDICATIONS 

Patients with hypersensitivity to triamcinolone acetonide or any component of the product. ( 4) 

WARNINGS AND PRECAUTIONS 

Intra-articular Use Only: Do not administer ZILRETTA by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ( 5.1) 

Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use. ( 5.2) 

Hypersensitivity Reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care upon occurrence of an anaphylactic reaction. ( 5.3) 

Joint Infection and Damage: May cause joint pain accompanied by joint swelling. If this occurs, conduct appropriate eva luation to exclude septic arthritis and institute appropriate antimicrobial therapy if septic arthritis is confirmed. ( 5.4) 

ADVERSE REACTIONS 

Most commonly reported adverse reactions (incidence ≥1%) in clinical studies include sinusitis, cough, and contusions. ( 6) 

To report SUSPECTED ADVERSE REACTIONS, contact Flexion Therapeutics, Inc. at 1-844-FLEXION (353-9466) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 10/2017

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE  

2 DOSAGE AND ADMINISTRATION  

2.1 Important Dosage and Administration Information  

2.2 Preparation and Administration of Intra-Articular Suspension  

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

3 DOSAGE FORMS AND STRENGTHS  

4 CONTRAINDICATIONS