New ZILRETTA
NDC Number

65250-0003-01

HCPCS Code HCPCS Code Descriptor NDC Number Labeler NDC Description
J3304 Injection triamcinolone acetonide, preservative free, extended release, microsphere formulation, 1 mg New NDC: 65250-0003-01 Pacira Biosciences ZILRETTA (triamcinolone acetonide extended-release injectable suspension) single-dose kit.
J3304 Injection triamcinolone acetonide, preservative free, extended release, microsphere formulation, 1 mg Existing NDC: 70801-0003-01 Flexion Therapeutics ZILRETTA (triamcinolone acetonide extended-release injectable suspension) single-dose kit.
For more information, please contact reimbursement@pacira.com
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EXTENDED RELEASE

FOR EXTENDED RELIEF

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

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WHY ZILRETTA?

Explore ZILRETTA and learn why it may be right for your patients experiencing OA knee pain.

LOCAL

  • Microspheres localize in the synovial tissue, a source of OA knee pain and inflammation1
  • In a pharmacokinetic study, TA concentration in the synovial fluid was expressed through 12 weeks2
    • The relevance of the synovial fluid data to the efficacy and safety of ZILRETTA has not been established
Explore the microspheres

RAPID

  • 4 days median time to onset with ZILRETTA3*
Explore joint residence time

PERSISTENT

  • ≥50% reduction from baseline pain intensity at Week 124
  • Significant reduction in pain from Weeks 1-12, extending to Week 163,5
Explore the efficacy data

SAFETY

  • The overall incidence and nature of adverse reactions were similar to saline control
  • Most commonly reported treatment-emergent adverse reactions (incidence ≥1%) in clinical studies were sinusitis, cough, and contusions
Explore the safety data

*Defined as time from IA injection to the first daily pain assessment of >30% improvement from baseline.


ZILRETTA CAN IMPROVE PATIENT OUTCOMES OVER IMMEDIATE-RELEASE CORTICOSTEROIDS6

Evidence-based review highlights the potential of ZILRETTA to improve outcomes in patients with OA knee pain6

When we differentiated intra-articular corticosteroids extended versus immediate release... (Bodick 2015, Conaghan 2018, and Langworthy 2019), our analyses demonstrated that, extended release IA steroids can be used over immediate release to improve patient outcomes. 6†

American Academy of Orthopaedic Surgeons Management of Osteoarthritis of the Knee (Non-Arthroplasty) Evidence-Based Clinical Practice Guideline

See Clinical Practice Guideline

†Moderate strength recommendation. Evidence from two or more “Moderate” quality studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. Also requires no or only minor concerns addressed in the EtD framework.6

Evidence Based

  • Based on a systematic review of 25 high and moderate quality studies, the American Academy of Orthopaedic Surgeons (AAOS) updated the evidence-based clinical practice guideline on management of osteoarthritis of the knee (OAK) in August 2021—for the first time since 20136

Differentiated Benefit

  • Three key publications (Bodick 2015, Conaghan 2018, and Langworthy 2019) supported the differential analysis indicating benefit of extended-release intra-articular steroids (IAS) over immediate-release corticosteroids to improve patient outcomes6
Intra-articular (IA) corticosteroids could provide short-term relief for patients with symptomatic OA of the knee.6

WANT TO KNOW MORE ABOUT ZILRETTA?

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LEARN ABOUT THE EVOLVING ROLE OF ZILRETTA

John Richmond, MD, reviews the clinical data for ZILRETTA and moderates a dynamic panel with Ira Evans, MD, Scott Sigman, MD, and Jason Rand, MD.

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We’ve deployed the Z Team, a dedicated patient concierge program to connect patients with healthcare providers who have experience with ZILRETTA. Register to see if you are eligible to be part of our Provider Locator tool and let our Z Team members bring interested patients directly to you.

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Indication and Important Safety Information

Indication

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.

Contraindication

ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids, or any components of the product.

Warnings and Precautions

  • Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. Serious events have been reported with epidural and intrathecal administration of corticosteroids and none are approved for this use. ZILRETTA should not be considered safe for epidural or intrathecal administration.
  • Hypersensitivity Reactions: Rare instances of anaphylaxis, including serious cases, have occurred in patients with hypersensitivity to corticosteroids.
  • Joint Infection and Damage: A marked increase in pain accompanied by local swelling, restriction of joint motion, fever, and malaise are suggestive of septic arthritis. Examine joint fluid to exclude a septic process. If diagnosis is confirmed, institute appropriate antimicrobial therapy. Avoid injecting corticosteroids into a previously infected or unstable joint. Intra-articular administration may result in damage to joint tissues.
  • Increased Risk of Infections: Infection with any pathogen in any location of the body may be associated with corticosteroid use. Corticosteroids may increase the susceptibility to new infection and decrease resistance and the ability to localize infection.
  • Alterations in Endocrine Function: Corticosteroids can produce reversible hypothalamic-pituitary-adrenal axis suppression, with potential for adrenal insufficiency after withdrawal of treatment, which may persist for months. In situations of stress during that period, institute corticosteroid replacement therapy.
  • Cardiovascular and Renal Effects: Corticosteroids can cause blood pressure elevation, salt and water retention, and increased potassium excretion. Monitor patients with congestive heart failure, hypertension, and renal insufficiency for edema, weight gain, and electrolyte imbalance. Dietary salt restriction and potassium supplementation may be needed.
  • Increased Intraocular Pressure: Corticosteroid use may be associated with increased intraocular pressure. Monitor patients with elevated intraocular pressure for potential treatment adjustment.
  • Gastrointestinal Perforation: Corticosteroid administration may increase risk of gastrointestinal perforation in patients with certain GI disorders and fresh intestinal anastomoses. Avoid corticosteroids in these patients.
  • Alterations in Bone Density: Corticosteroids decrease bone formation and increase bone resorption. Special consideration should be given to patients with or at increased risk of osteoporosis prior to treatment.
  • Behavior and Mood Disturbances: Corticosteroids may cause adverse psychiatric reactions. Prior to treatment, special consideration should be given to patients with previous or current emotional instability or psychiatric illness. Advise patients to immediately report any behavior or mood disturbances.

Adverse Reactions

The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.

Please see full Prescribing Information.

References:

  1. Bodick N, Lufkin J, Willwerth C, et al. An intra-articular, extended-release formulation of triamcinolone acetonide prolongs and amplifies analgesic effect in patients with osteoarthritis of the knee: a randomized clinical trial. J Bone Joint Surg Am. 2015;97(11):877-888.
  2. Kraus VB, Conaghan PG, Aazami HA, et al. Synovial and systemic pharmacokinetics (PK) of triamcinolone acetonide (TA) following intra-articular (IA) injection of an extended-release microsphere-based formulation (FX006) or standard crystalline suspension in patients with knee osteoarthritis (OA). Osteoarthr Cartilage. 2018;26(1):34-42.
  3. Conaghan PG, Hunter DJ, Cohen SB, et al. Effects of a single intra-articular injection of a microsphere formulation of triamcinolone acetonide on knee osteoarthritis pain: a double-blinded, randomized, placebo-controlled, multinational study. J Bone Joint Surg Am. 2018;100(8)666-677.
  4. Ross E, Katz NP, Conaghan PG, et al. Improved treatment effect of triamcinolone acetonide extended release in patients with concordant baseline pain scores on the average daily pain and Western Ontario and McMaster Universities osteoarthritis index pain scales. Pain Ther. 2022;11(1):289-302.
  5. Data on file. Pacira Therapeutics, Inc.
  6. American Academy of Orthopaedic Surgeons Management of Osteoarthritis of the Knee (NonArthroplasty) Evidence-Based Clinical Practice Guideline. https://www.aaos.org/oak3cpg Published August 30, 2021. Accessed March 15, 2023

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