ZILRETTA

ZILRETTA is an extended-release dosage form consisting of microspheres of poly(lactic-co-glycolic acid) (PLGA) containing triamcinolone acetonide. Plasma pharmacokinetic parameters for triamcinolone acetonide following IA administration of ZILRETTA or 40 mg immediate-release triamcinolone acetonide into the knee are provided in Table 4.

Table 4Summary of Mean (SD) Plasma Pharmacokinetic Parameters for Triamcinolone Acetonide Following IA Administration of ZILRETTA or 40 mg Immediate-Release Tr...

The efficacy of ZILRETTA was demonstrated in a multi-center, international, randomized, double-blind, parallel-arm, placebo- and active-controlled study in patients with osteoarthritis pain of the knee. A total of 484 patients (ZILRETTA 32 mg, N=161; placebo [saline], N=162; active control [a crystalline suspension, immediate-release formulation of triamcinolone acetonide 40 mg], N=161) were treated and followed for up to 24 weeks. Patients had a mean age of 62 (range 40 to 85 years); baseline demographics and disease characteristics were balanced across treatment arms. Twenty-five percent (25...

The following serious adverse reactions are described elsewhere in the labeling. Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Joint Infection and Damage [see Warnings and Precautions (5.4) ] Increased Risk of Infections [see Warnings and Precautions (5.5) ] Alterations in Endocrine Function [see Warnings and Precautions (5.6) ] Cardiovascular Effects [see Wa...

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

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 ...

7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with ZILRETTA. Table 3 contains drug interactions associated with systemic corticosteroids.

Table 3Drug Interactions Associated with Systemic Corticosteroids Aminoglutethimide Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression. Amphotericin B injection and potassium-depleting agents When cort...