Pharmaceutical Guide - 2020 - 3

Zilretta

CHRONIC OA KNEE PAIN
MEET YOUR MATCH
The first and only approved treatment for
OA knee pain utilizing extended-release
microsphere technology
To order ZILRETTA, contact your Henry Schein Sales
Consultant or visit www.henryschein.com/medical
To learn more about ZILRETTA, call 781-562-4389
or email GetZ@flexiontherapeutics.com

ZILRETTA has a permanent,
product-specific J-code

J3304

ZILRETTA is not interchangeable with other formulations of injectable triamcinolone acetonide.

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.
Please see brief summary of full Prescribing Information
on the adjacent page.
Learn more at ZilrettaPro.com
January 2020. Z-01076

20MS4988

henryschein.com/medical

http://www.henryschein.com/medical http://www.ZilrettaPro.com http://www.henryschein.com/medical

Pharmaceutical Guide - 2020

Table of Contents for the Digital Edition of Pharmaceutical Guide - 2020