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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.
