Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 (5.11) ] Behavioral and Mood Disturbances [see Warnings and Precautions (5.12) ] Most commonly reported adverse reactions (incidence ≥1%) in clinical studies include sinusitis, cough, and contusions.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pacira Pharmaceuticals, Inc.
at 1-844-353-9466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data below reflect exposure to a single 32 mg intra-articular injection of ZILRETTA in clinical studies in patients with moderate to severe pain due to osteoarthritis of the knee.
Clinical studies included randomized, double-blind, parallel-group, placebo and/or active-controlled, and pharmacokinetic/pharmacodynamic studies with follow-up ranging from 6-24 weeks.
A total of 424 patients received ZILRETTA and 262 received placebo.
Treatment emergent adverse reactions reported by greater than or equal to 1% of patients in the ZILRETTA arms are summarized below ( Table 1 and 2 ).
Overall, the incidence and nature of adverse reactions was similar to that observed with placebo.
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.
Like all medications, Zilretta can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: