OZURDEX INTRAVITREAL IMPLANT 0.7MG [SIN14058P]

Product Info

OZURDEX INTRAVITREAL IMPLANT 0.7MG

[SIN14058P]

1 INDICATIONS AND USAGE

OZURDEX® (dexamethasone intravitreal implant) is indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

OZURDEX® (dexamethasone intravitreal implant) is indicated for the treatment of non-infectious uveitis affecting the posterior segment of the eye.

OZURDEX® (dexamethasone intravitreal implant) is indicated for the treatment of patients with visual impairment due to diabetic macular edema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

For ophthalmic intravitreal injection only. The recommended dose is one OZURDEX® implant to be administered intravitreally to the affected eye. Administration to both eyes concurrently is not recommended.

In DME, retreatment may be performed after approximately 6 months if the patient experiences decreased vision and/or an increase in retinal thickness, secondary to recurrent or worsening diabetic macular edema.

There is currently no experience of the efficacy or safety of repeat administrations in DME beyond 7 implants.

There is only very limited information on repeat dosing intervals less than 6 months. There is currently no experience of repeat administrations beyond 2 implants in Retinal Vein Occlusion.

2.2 Administration

The intravitreal injection procedure should be carried out under controlled aseptic conditions which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Disinfection of the periocular skin, eyelid, and ocular surface (for example, drops of povidone iodine 5% solution on the conjunctiva) and administration of adequate local anesthesia and a broad-spectrum microbicide are recommended to be given prior to the injection.

Remove the foil pouch from the carton and examine for damage. Then, in a sterile field, open the foil pouch and gently place the applicator on a sterile tray. Carefully remove the cap from the applicator. Hold the applicator in one hand and pull the safety tab straight off the applicator. Do not twist or flex the tab. The long axis of the applicator should be held parallel to the limbus, and the sclera should be engaged at an oblique angle with the bevel of the needle up (away from the sclera) to create a shelved scleral path. The tip of the needle is advanced within the sclera for about 1 mm (parallel to the limbus), then re-directed toward the center of the eye and advanced until penetration of the sclera is completed and the vitreous cavity is entered. The needle should not be advanced past the point where the sleeve touches the conjunctiva.

Slowly depress the actuator button until an audible click is noted. Before withdrawing the applicator from the eye, make sure that the actuator button is fully depressed and has locked flush with the applicator surface. Remove the needle in the same direction as used to enter the vitreous.

Following the intravitreal injection, patients should be monitored for elevation 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 any symptoms suggestive of endophthalmitis without delay.

Each applicator can only be used for the treatment of a single eye.

4. CONTRAINDICATIONS

4.1 Ocular or Periocular Infections

OZURDEX® (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

4.2 Advanced Glaucoma

OZURDEX® is contraindicated in patients with advanced glaucoma.

4.3 Aphakic eyes with ruptured posterior lens capsule

OZURDEX® is contraindicated in aphakic eyes with ruptured posterior lens capsule.

4.4 Eyes with ACIOL, iris or transscleral fixated IOLs and ruptured posterior lens capsule

OZURDEX® is contraindicated in eyes with ACIOL (Anterior Chamber Intraocular Lens), iris or transscleral fixated IOLs and ruptured posterior lens capsule.

4.5 Hypersensitivity

OZURDEX® is contraindicated in patients with known hypersensitivity to dexamethasone or to any other components of this product.