ZILRETTA® by Flexion Therapeutics, Inc.


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Indications & Usage

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

demonstrated.

 

 

See section 1 in full Prescribing Information for further information on Indications & Usage.

Dosage & Administration

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.

 

 

See section 2 and 3 in full Prescribing Information for further information on Dosage and Administration and Dosage Forms and Strengths.  See also Instructions for Use.

Contraindications

CONTRAINDICATIONS

 

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 & Precautions

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.

Adverse Reactions

ADVERSE REACTIONS

 

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.

ICD-10 Codes

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

Please see full Prescribing Information.

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.