Yutiq
(fluocinolone acetonide)Dosage & Administration
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Yutiq Prescribing Information
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.
. General Dosing Information
For ophthalmic intravitreal injection.
. Administration
The intravitreal injection procedure should be carried out under aseptic conditions, which include use of sterile gloves, a sterile drape, a sterile caliper, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection.
The injection procedure for YUTIQ is as follows:
- Just prior to injection, administer topical and/or subconjunctival anesthesia at the injection site (inferotemporal quadrant recommended).
- Administer 2-3 drops of a broad-spectrum microbicide into the lower fornix. The lids may be scrubbed with cotton-tipped applicators soaked with a broad-spectrum microbicide. Place a sterile lid speculum. Have the patient look up and apply additional microbicide solution to the injection site. Allow 30-60 seconds for the topical antiseptic to dry prior to injection of YUTIQ.
- Optimal placement of YUTIQ is inferior to the optic disc and posterior to the equator of the eye. Measure 4 millimeters inferotemporal from the limbus with the aid of callipers for point of entry into the sclera.
- Using sterile procedure, open the sterile foil pouch containing YUTIQ.
- Remove the YUTIQ applicator from the sterile pouch by grasping the barrel of the applicator; do not grasp the plunger.
- Remove the black plunger stop from the plunger.
- Carefully remove the protective cap from the needle and inspect the needle tip to ensure it is not bent.
- Remove the trombone wire from the distal end of the needle. Prior to injection, keep the applicator tip above the horizontal plane to ensure that the YUTIQ implant does not fall out of the applicator.
- Gently displace the conjunctiva so that after withdrawing the needle, the conjunctival and scleral needle entry sites will not align. Care should be taken to avoid contact between the needle and the lid margin or lashes.
- Insert the needle through the conjunctiva and sclera up to the positive stop of the applicator.
- Depress the plunger at the back of the applicator fully to deliver the YUTIQ implant into the back of the eye.
- Remove the YUTIQ applicator from the eye and discard in biohazard sharps container.
- Remove the lid speculum and perform indirect ophthalmoscopy to verify adequate central retinal artery perfusion, absence of any other complications, and to verify the placement of the implant. Scleral depression may enhance visualisation of the implant. Immediate measurement of intraocular pressure (IOP) may be performed at the discretion of the ophthalmologist.
Following the injection, patients should be monitored for change in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients should be instructed to report without delay any symptoms suggestive of endophthalmitis.
YUTIQ is a non-bioerodible intravitreal implant in a drug delivery system containing 0.18 mg fluocinolone acetonide, designed to release fluocinolone acetonide at an initial rate of 0.25 mcg/day, and lasting 36 months.
Pregnancy
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.
Lactation
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.
Pediatric Use
Safety and effectiveness of YUTIQ in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
. Ocular or Periocular Infections
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.
. Hypersensitivity
YUTIQ is contraindicated in patients with known hypersensitivity to any components of this product.
. Intravitreal Injection-related Effects
Intravitreal injections, including those with YUTIQ, have been associated with endophthalmitis, eye inflammation, increased or decreased intraocular pressure, and choroidal or retinal detachments. Hypotony has been observed within 24 hours of injection and has resolved within 2 weeks. Patients should be monitored following the intravitreal injection [see Patient Counseling Information ( 17)] .
. Steroid-related Effects
Use of corticosteroids including YUTIQ may produce posterior subcapsular cataracts, increased intraocular pressure and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.
Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.
. Risk of Implant Migration
Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber.