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.
Limitation of Use
The efficacy and safety of repeat administration of ZILRETTA have not been
See section 1 in full Prescribing Information for further information on Indications & Usage.
DOSAGE AND ADMINISTRATION
· 32 mg administered as a single intra-articular injection in the knee.
· See Instructions for Use (IFU) for instructions on reconstitution of ZILRETTA with the supplied diluent.
· It is normal for some residue to be left behind on the vial walls after withdrawing the suspension.
· Not interchangeable with other formulations of injectable triamcinolone acetonide.
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.
Patients with hypersensitivity to triamcinolone acetonide or any component of the product.
See section 4 in full Prescribing Information for further information on Contraindications.
WARNINGS AND PRECAUTIONS
· Intra-articular Use Only: Do not administer ZILRETTA by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes.
· 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.
· Hypersensitivity Reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care upon occurrence of an anaphylactic reaction.
· Joint Infection and Damage: May cause joint pain accompanied by joint swelling. If this occurs, conduct appropriate evaluation to exclude septic arthritis and institute appropriate antimicrobial therapy if septic arthritis is confirmed.
See section 5 in full Prescribing Information for further information on Warnings and Precautions.
The most commonly reported adverse reactions (incidence ≥1%) in clinical studies include sinusitis, cough, and contusions.
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 section 6 in full Prescribing Information for further information on Adverse Reactions.
Osteoarthritis of the knee
M17 Osteoarthritis of knee
M17.0 Bilateral primary osteoarthritis of knee
M17.1 Unilateral primary osteoarthritis of knee
M17.10 Unilateral primary osteoarthritis, unspecified knee
M17.11 Unilateral primary osteoarthritis, right knee
M17.12 Unilateral primary osteoarthritis, left knee
M17.2 Bilateral post-traumatic osteoarthritis of knee
M17.3 Unilateral post-traumatic osteoarthritis of knee
M17.30 Unilateral post-traumatic osteoarthritis, unspecified knee
M17.31 Unilateral post-traumatic osteoarthritis, right knee
M17.32 Unilateral post-traumatic osteoarthritis, left knee
M17.4 Other bilateral secondary osteoarthritis of knee
M17.5 Other unilateral secondary osteoarthritis of knee
M17.9 Osteoarthritis of knee, unspecified
© 2020 Flexion Therapeutics, Inc. All rights reserved. ZILRETTA
and FLEXFORWARD are registered marks of Flexion Therapeutics, Inc.
June 2020. Z-01189
INDICATION AND IMPORTANT SAFETY INFORMATION
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: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated.
ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids, or any components of the product.
Warnings and Precautions
The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.
Please see full Prescribing Information.