INDICATIONS
AND USAGE
ZILRETTA is an
extended-release synthetic corticosteroid 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.
See section
1 in full Prescribing
Information for further information on Indications & Usage.
DOSAGE
AND ADMINISTRATION
·
32
mg administered as a single intra-articular injection in the knee.
·
See
Instructions for Use (IFU) for instructions on reconstitution of ZILRETTA with
the supplied diluent.
·
It
is normal for some residue to be left behind on the vial walls after
withdrawing the suspension.
·
Not
interchangeable with other formulations of injectable triamcinolone acetonide.
DOSAGE FORMS AND
STRENGTHS
ZILRETTA is an injectable
suspension that delivers 32 mg of triamcinolone acetonide. It is supplied as a
single-dose kit containing one vial of ZILRETTA microsphere powder, one vial of
5 mL diluent, and one sterile vial adapter.
See section
2 and 3 in full Prescribing
Information for further information on Dosage and Administration and Dosage
Forms and Strengths. See also Instructions for Use.
CONTRAINDICATIONS
Patients with
hypersensitivity to triamcinolone acetonide or any component of the product.
See section
4 in full Prescribing
Information for further information on Contraindications.
WARNINGS
AND PRECAUTIONS
· Intra-articular Use Only: Do not administer ZILRETTA by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes.
· 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.
· Hypersensitivity Reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care upon occurrence of an anaphylactic reaction.
·
Joint Infection and Damage: May cause
joint pain accompanied by joint swelling. If this occurs, conduct appropriate
evaluation to exclude septic arthritis and institute appropriate antimicrobial
therapy if septic arthritis is confirmed.
See section
5 in full Prescribing
Information for further information on Warnings and Precautions.
ADVERSE
REACTIONS
The most commonly reported
adverse reactions (incidence ≥1%) in clinical studies include sinusitis, cough,
and contusions.
To report SUSPECTED
ADVERSE REACTIONS, contact Flexion Therapeutics, Inc. at 1-844-FLEXION
(353-9466) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See section
6 in full Prescribing
Information for further information on Adverse Reactions.
Osteoarthritis
of the knee
M17 Osteoarthritis of knee
M17.0 Bilateral primary osteoarthritis of knee
M17.1 Unilateral primary osteoarthritis of knee
M17.10 Unilateral primary osteoarthritis,
unspecified knee
M17.11 Unilateral primary osteoarthritis, right
knee
M17.12 Unilateral primary osteoarthritis, left knee
M17.2 Bilateral post-traumatic osteoarthritis
of knee
M17.3 Unilateral post-traumatic osteoarthritis
of knee
M17.30 Unilateral post-traumatic osteoarthritis,
unspecified knee
M17.31 Unilateral post-traumatic osteoarthritis,
right knee
M17.32 Unilateral post-traumatic osteoarthritis,
left knee
M17.4 Other bilateral secondary osteoarthritis
of knee
M17.5 Other unilateral secondary osteoarthritis
of knee
M17.9 Osteoarthritis of knee, unspecified
© 2020 Flexion Therapeutics, Inc. All rights reserved. ZILRETTA
and FLEXFORWARD are registered marks of Flexion Therapeutics, Inc.
June 2020. Z-01189
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
Adverse
Reactions
The
most commonly reported adverse reactions (incidence ≥1%) in clinical studies
included sinusitis, cough, and contusions.
Please
see full Prescribing
Information.