Triamcinolone Acetonide Extended-release Injectable Suspension
Generic Name: triamcinolone acetonide extended-release injectable suspension
Brand Names:
Zilretta
11 DESCRIPTION ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is a microsphere formulation of triamcinolone acetonide, a corticosteroid, to be administered by intra-articular injection. ZILRETTA is formulated in 75:25 poly(lactic-co-glycolic acid) (PLGA) microspheres with a nominal drug load of 25% (w/w) and is provided as a sterile white to off-white powder.
Overview
11 DESCRIPTION ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is a microsphere formulation of triamcinolone acetonide, a corticosteroid, to be administered by intra-articular injection. ZILRETTA is formulated in 75:25 poly(lactic-co-glycolic acid) (PLGA) microspheres with a nominal drug load of 25% (w/w) and is provided as a sterile white to off-white powder.
Uses
1 INDICATIONS AND USAGE ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. 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 The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. ( 2.1 ) Limitation of Use The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. [see Dosage and Administration (2.1) ] .
Dosage
2 DOSAGE AND ADMINISTRATION 32 mg (5 mL) 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 ) ZILRETTA is NOT substitutable with other formulations of injectable triamcinolone acetonide. ( 2.3 ) 2.1 Important Dosage and Administration Information ZILRETTA is administered as a single intra-articular extended-release injection of triamcinolone acetonide, to deliver 32 mg (5 mL). ZILRETTA is for intra-articular use only. Do NOT administer by the following routes: epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, subcutaneous.
Side Effects
6 ADVERSE REACTIONS 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 Warnings and Precautions (5.7) ] Renal Effects [see Warnings and Precautions (5.8) ] Increased Intraocular Pressure [see Warnings and Precautions (5.9) ] Gastrointestinal Perforation [see Warnings and Precautions (5.10) ] Alternations in Bone Density [see Warnings and Precautions (...
Interactions
7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with ZILRETTA. Table 3 contains drug interactions associated with systemic corticosteroids. Table 3: Drug 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 corticosteroids are administered concomitantly with potassium-depleting agents (i.e., amphotericin B, diuretics), observe patients closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
Warnings
5 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. 4 CONTRAINDICATIONS 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 )
Pregnancy
8.1 Pregnancy Risk Summary There are no data regarding the use of ZILRETTA in pregnant women to inform a drug associated risk of adverse developmental outcomes. Published studies on the association between corticosteroids and fetal outcomes have reported inconsistent findings and have important methodological limitations . The majority of published literature with corticosteroid exposure during pregnancy includes the oral, topical and inhaled dosage formulations; therefore, the applicability of these findings to a single intra-articular injection of triamcinolone acetonide is limited.
Storage
STORAGE To maintain expiry period, refrigerate the ZILRETTA single-dose kit 2°-8°C (36°-46°F) before use. If refrigeration is unavailable, store the ZILRETTA single-dose kit in the sealed, unopened kit at temperatures not exceeding 25°C (77°F) for up to three weeks and then discard. Do not expose the ZILRETTA single-dose kit to temperatures above 25°C (77°F). Do not freeze. Store vials in carton.
Frequently Asked Questions
What is Triamcinolone Acetonide Extended-release Injectable Suspension used for?▼
1 INDICATIONS AND USAGE ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. 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 The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. ( 2.1 ) Limitation of Use The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. [see Dosage and Administration (2.1) ] .
What are the side effects of Triamcinolone Acetonide Extended-release Injectable Suspension?▼
6 ADVERSE REACTIONS 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 Warnings and Precautions (5.7) ] Renal Effects [see Warnings and Precautions (5.8) ] Increased Intraocular Pressure [see Warnings and Precautions (5.9) ] Gastrointestinal Perforation [see Warnings and Precautions (5.10) ] Alternations in Bone Density [see Warnings and Precautions (...
Can I take Triamcinolone Acetonide Extended-release Injectable Suspension during pregnancy?▼
8.1 Pregnancy Risk Summary There are no data regarding the use of ZILRETTA in pregnant women to inform a drug associated risk of adverse developmental outcomes. Published studies on the association between corticosteroids and fetal outcomes have reported inconsistent findings and have important methodological limitations . The majority of published literature with corticosteroid exposure during pregnancy includes the oral, topical and inhaled dosage formulations; therefore, the applicability of these findings to a single intra-articular injection of triamcinolone acetonide is limited.
What are the important warnings for Triamcinolone Acetonide Extended-release Injectable Suspension?▼
5 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. 4 CONTRAINDICATIONS 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.