Pharmaceutical Guide - 2020 - 4

Zilretta
ZILRETTA® (triamcinolone acetonide extended-release
injectable suspension) for intra-articular use
BRIEF SUMMARY OF PRESCRIBING INFORMATION: See
package insert for full Prescribing Information.
1. INDICATIONS AND USAGE
ZILRETTA is indicated as an intra-articular (IA) injection for
the management of osteoarthritis (OA) pain of the knee.
Limitation of Use: The efficacy and safety of repeat
administration of ZILRETTA have not been demonstrated.
4. CONTRAINDICATION
ZILRETTA is contraindicated in patients who are
hypersensitive to triamcinolone acetonide (TA),
corticosteroids (CSs), or any components of the product.
5. WARNINGS AND PRECAUTIONS
5.1 Warnings and Precautions Specific for ZILRETTA
ZILRETTA has not been evaluated and should not be
administered by the following routes: epidural, intrathecal,
intravenous, intraocular, intramuscular, intradermal,
or subcutaneous.
5.2 Serious Neurologic Adverse Reactions With Epidural and
Intrathecal Administration Serious neurologic events, some
resulting in death, have been reported with epidural injection
of CSs. Specific events reported include, but are not limited
to, spinal cord infarction, paraplegia, quadriplegia, cortical
blindness, and stroke. These serious neurologic events
have been reported with and without use of fluoroscopy.
Reports of serious medical events have been associated
with the intrathecal route of CS administration. The safety
and effectiveness of epidural and intrathecal administration
of CSs have not been established, and CSs are not approved
for this use. In particular, the formulation of ZILRETTA should
not be considered safe to use for epidural or intrathecal
administration.
5.3 Hypersensitivity Reactions Rare instances of anaphylaxis
have occurred in patients with hypersensitivity to CSs.
Cases of serious anaphylaxis, including death, have been
reported in individuals receiving TA injection, regardless of
the route of administration. Institute appropriate care if an
anaphylactic reaction occurs.
5.4 Joint Infection and Damage IA injection of a CS may
be complicated by joint infection. A marked increase in
pain accompanied by local swelling, further restriction of
joint motion, fever, and malaise are suggestive of septic
arthritis. If this complication occurs and a diagnosis of septic
arthritis is confirmed, institute appropriate antimicrobial
therapy. Avoid injection of a CS into an infected site. Local
injection of a CS into a previously infected joint is not usually
recommended. Examine any joint fluid present to exclude a
septic process. CS injection into unstable joints is generally
not recommended. IA injection may result in damage
to joint tissues.
5.5 Increased Risk of Infections Intra-articularly injected CSs
are systemically absorbed. Patients who are on CSs are more
susceptible to infections than healthy individuals. There may
be decreased resistance and inability to localize infection
when CSs are used. Infection with any pathogen (viral,
bacterial, fungal, protozoan, or helminthic) in any location of
the body may be associated with the use of CSs alone or in
combination with other immunosuppressive agents. These
infections may be mild to severe. With increasing doses
of CSs, the rate of occurrence of infectious complications
increases. CSs may also mask some signs of current infection.
Advise patients to inform their health care provider (HCP) if
they develop fever or other signs or symptoms of infection.
Advise patients who have not been vaccinated to avoid
exposure to chicken pox or measles. Instruct patients to

4

contact their HCP immediately if they are exposed.
5.6 Alterations in Endocrine Function CSs 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 (as in trauma, surgery, or illness),
institute CS replacement therapy. Metabolic clearance of
CSs is decreased in hypothyroid patients and increased in
hyperthyroid patients.
5.7 Cardiovascular Effects CSs can cause elevations of
blood pressure, salt and water retention, and increased
excretion of potassium. These effects are less likely to occur
with synthetic derivatives. Monitor patients with congestive
heart failure (CHF) or hypertension for signs of edema, weight
gain, and imbalance in serum electrolytes. Dietary salt
restriction and potassium supplementation may
be necessary.
5.8 Renal Effects CSs can cause salt and water retention,
and increased excretion of potassium. These effects are
less likely to occur with synthetic derivatives. All CSs
increase calcium excretion. Monitor patients with renal
insufficiency for signs of edema, weight gain, and imbalance
in serum electrolytes. Dietary salt restriction and potassium
supplementation may be necessary.
5.9 Increased Intraocular Pressure CS use may be
associated with development or exacerbation of increased
intraocular pressure. Monitor patients with elevated
intraocular pressure for potential treatment adjustment.
5.10 Gastrointestinal (GI) Perforation CS administration is
associated with increased risk of GI perforation in patients
with certain GI disorders such as active or latent peptic
ulcers, diverticulosis, diverticulitis, ulcerative colitis, and
in patients with fresh intestinal anastomoses. Avoid CSs in
these patients because signs of peritoneal irritation following
GI perforation may be minimal or absent.
5.11 Alterations in Bone Density CSs decrease bone
formation and increase bone resorption through their effect
on calcium regulation and inhibition of osteoblast function.
Special consideration should be given to patients with or at
increased risk of osteoporosis (eg, postmenopausal women)
before initiating CS therapy.
5.12 Behavioral and Mood Disturbances CS use may be
associated with new or aggravated adverse psychiatric
reactions ranging from euphoria, insomnia, mood swings, and
personality changes to severe depression and frank psychotic
manifestations. Special consideration should be given to
patients with previous or current emotional instability or
psychiatric illness before initiating CS therapy. Advise patients
and/or caregivers to immediately report any new or worsening
behavior or mood disturbances to their HCP.
6. ADVERSE REACTIONS
6.1 Clinical Trials Experience Because clinical studies are
conducted under widely varying conditions, adverse reaction
rates observed in clinical trials of a drug cannot be directly
compared to rates in clinical studies of another drug and
may not reflect rates observed in practice. The data below
reflect exposure to a single 32mg IA injection of ZILRETTA in
clinical studies in patients with moderate to severe pain due
to knee OA. Clinical studies included randomized, doubleblind, parallel-group, placebo- and/or active-controlled, and
pharmacokinetic/pharmacodynamic studies with follow-up
ranging from 6-24 weeks. 424 patients received ZILRETTA;
262 received placebo. The most commonly reported
treatment-emergent adverse reactions (incidence ≥1% with
ZILRETTA) in the ZILRETTA vs placebo arms were sinusitis,
cough, and contusions (2% vs 1% each) and in the injected

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