YUTIQ- fluocinolone acetonide implant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)

Available from:

EyePoint Pharmaceuticals, Inc

Administration route:

INTRAOCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. YUTIQ is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. YUTIQ is contraindicated in patients with known hypersensitivity to any components of this product. Risk Summary Adequate and well-controlled studies with YUTIQ have not been conducted in pregnant women to inform drug associated risk. Animal reproduction studies have not been conducted with YUTIQ. It is not known whether YUTIQ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. YUTIQ should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary Systemically administered corticosteroids are present in human milk and can suppress growth, interfere with endogenous corticosteroid production. Clinical or nonclinical lactation studies have not been conducted with YUTIQ. It is not known whether intravitreal treatment with YUTIQ could result in sufficient systemic absorption to produce detectable quantities of fluocinolone acetonide in human milk, or affect breastfed infants or milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for YUTIQ and any potential adverse effects on the breastfed child from YUTIQ. Safety and effectiveness of YUTIQ in pediatric patients have not been established. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Product summary:

YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg is supplied in a sterile single-dose preloaded applicator with a 25-gauge needle, packaged in a sealed sterile foil pouch inside a sealed Tyvek pouch inside a carton box. NDC 71879-136-01 Storage: Store at 15° C to 30° C (59° F to 86° F).

Authorization status:

New Drug Application

Summary of Product characteristics

YUTIQ- FLUOCINOLONE ACETONIDE IMPLANT
EYEPOINT PHARMACEUTICALS, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
YUTIQ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR YUTIQ.
YUTIQ (FLUOCINOLONE ACETONIDE INTRAVITREAL IMPLANT) 0.18 MG, FOR
INTRAVITREAL INJECTION
INITIAL U.S. APPROVAL: 1963
INDICATIONS AND USAGE
YUTIQ contains a corticosteroid and is indicated for the treatment of
chronic non-infectious uveitis affecting
the posterior segment of the eye. ( 1)
DOSAGE AND ADMINISTRATION
For ophthalmic intravitreal injection. ( 2.1)
The intravitreal injection procedure should be carried out under
aseptic conditions. ( 2.2)
Following the intravitreal injection, patients should be monitored for
elevation in intraocular pressure
and for endophthalmitis. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Non-bioerodible intravitreal implant containing 0.18 mg fluocinolone
acetonide in a drug delivery system. (
3)
CONTRAINDICATIONS
Ocular or periocular infections ( 4.1)
Hypersensitivity ( 4.2)
WARNINGS AND PRECAUTIONS
Intravitreal injections have been associated with endophthalmitis, eye
inflammation, increased
intraocular pressure, and retinal detachments. Patients should be
monitored following the injection. (
5.1)
Use of corticosteroids may produce posterior subcapsular cataracts,
increased intraocular pressure,
glaucoma, and may enhance the establishment of secondary ocular
infections due to bacteria, fungi, or
viruses. ( 5.2)
The implant may migrate into the anterior chamber if the posterior
lens capsule is not intact. ( 5.3)
ADVERSE REACTIONS
In controlled studies, the most common adverse reactions reported were
cataract development and
increases in intraocular pressure. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT EYEPOINT
PHARMACEUTICALS US, INC. AT 1-
833-EYEPOINT (1-833-393-7646) OR FDA AT 1-800-FDA-1088 OR
www.fda.gov/medwatch.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1. INDICATION