YUTIQ

Clinical summary

Indications and usage 1. INDICATIONS AND USAGE 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 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 2. 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 ) 2.1. General Dosing Information For ophthalmic intravitreal injection. 2.2. 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. Warnings and cautions 5. 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 ) 5.1. 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 )] . 5.2. 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 b