Pharmaceutical Guide - 2020 - 6

Zilretta

skin tests. Vaccines: Patients on prolonged corticosteroid
(CS) therapy may exhibit a diminished response to toxoids
and live or inactivated vaccines due to inhibition of antibody
response. CSs may also potentiate the replication of some
organisms contained in live attenuated vaccines. If possible,
defer routine administration of vaccines or toxoids until CS
therapy is discontinued.
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk Summary: There are no data regarding
use of ZILRETTA in pregnant women to inform a drugassociated risk of adverse developmental outcomes.
Published studies on the association between CSs and
fetal outcomes have reported inconsistent findings and
have important methodological limitations. The majority of
published literature with CS exposure during pregnancy
includes oral, topical, and inhaled dosage formulations;
therefore, the applicability of these findings to a single
intra-articular (IA) injection of triamcinolone acetonide
(TA) is limited. In animal reproductive studies from the
published literature, pregnant mice, rats, rabbits, or primates
administered TA during the period of organogenesis at
doses that produced exposures less than the maximum
recommended human dose (MRHD) caused resorptions,
decreased fetal body weight, craniofacial, and/or other
abnormalities such as omphalocele. The estimated
background risk of major birth defects and miscarriage for
the indicated population is unknown. All pregnancies have
a background risk of birth defect, loss, or other adverse
outcomes. In the US general population, the estimated risk of
major birth defects and miscarriage in clinically recognized
pregnancies is 2-4% and 15-20%, respectively.
8.2 Lactation Risk Summary: There are no available data
on presence of TA in human or animal milk, effects on the
breastfed infant, or effects on milk production. However,
CSs have been detected in human milk and may suppress
milk production. It is not known whether IA administration
of ZILRETTA could result in sufficient systemic absorption
to produce detectable quantities in human milk. The
developmental and health benefits of breastfeeding should
be considered along with the mother's clinical need for
ZILRETTA and any potential adverse effects on the breastfed
infant from ZILRETTA.
8.3 Females and Males of Reproductive Potential CSs may
result in menstrual pattern irregularities such as deviations
in timing and duration of menses and an increased or
decreased loss of blood.
8.4 Pediatric Use The safety and effectiveness of ZILRETTA
in pediatric patients have not been established. The adverse
effects of CSs in pediatric patients are similar to those in
adults. Carefully observe pediatric patients, including weight,
height, linear growth, blood pressure, intraocular pressure,
and clinical evaluation for the presence of infection,

psychosocial disturbances, thromboembolism, peptic ulcers,
cataracts, and osteoporosis. Weigh potential growth effects
of treatment against clinical benefits obtained and availability
of treatment alternatives.
8.5 Geriatric Use Of the total number of patients
administered 32mg ZILRETTA in clinical studies (N=424), 143
patients were ≥65 years old. No overall differences in safety
or effectiveness were observed between elderly and younger
subjects, and other reported clinical experience with TA has
not identified differences in responses between elderly and
younger patients. However, greater sensitivity of some older
individuals cannot be ruled out.
13. NONCLINICAL TOXICOLOGY
13.2 Animal Toxicology and/or Pharmacology Single and
repeat administrations (1 injection every 3 months for
a total of 3 injections) of ZILRETTA in non-arthritic knee
joints of healthy dogs have been studied at ~1.9xMRHD of
32mg (based on estimated drug concentrations within the
knee joints). ZILRETTA microspheres were degraded by
approximately 4- and 6-months post dosing in single and
repeat dose studies, respectively. Single administration
resulted in slightly increased incidence, severity (minimal to
slight), and/or duration of microscopic changes (infiltration
of macrophages, lymphocytes, plasma cells, and fibrosis)
and decreased Safranin O staining (decreased proteoglycan
content in knee cartilage) vs administration of an equivalent
dose of immediate-release (IR) TA. These responses were
mostly reversed after 6 to 9 months post injection. Repeat
administration resulted in an increase in incidence, severity
(minimal to slight), and duration of microscopic changes
(infiltration of macrophages, lymphocytes, plasma cells,
neutrophils; fibrosis; neovascularization; granulation tissue;
and debris) and decreased Safranin O staining (decreased
proteoglycan content in knee cartilage) vs the equivalent
dose of IR TA. These local responses were still reversing at
6 months post the last injection. No effect on the animals
according to observations related to gait/walking, pain/
discomfort in injected knee, local swelling, local redness, or
local tenderness were noted. The clinical relevance of these
findings in the arthritic knee is unknown.
The Brief Summary is based on the ZILRETTA
Prescribing Information
Part Number: 60-009-04, Version 4, 01/2020
Manufactured for Flexion Therapeutics, Inc.,
10 Mall Rd., Suite 301, Burlington, MA 01803
For more information, go to ZILRETTA.com or call
1-844-FLEXION (353-9466).

© 2020 Flexion Therapeutics, Inc. All rights reserved.
ZILRETTA and Flexion are registered trademarks of Flexion Therapeutics, Inc.
v4 January 2020. Z-00029v2

6

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