Dexycu

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE DEXYCU (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation. DEXYCU is a corticosteroid indicated for the treatment of postoperative inflammation ( 1 ). Dosage and administration 2 DOSAGE AND ADMINISTRATION For intraocular administration ( 2 ). Administer 0.005 mL of DEXYCU into the posterior chamber inferiorly behind the iris at the end of ocular surgery ( 2 ). 2.1 Dosing Information DEXYCU should be administered as a single dose, intraocularly in the posterior chamber at the end of surgery. The dose is 0.005 mL of dexamethasone 9% (equivalent to 517 micrograms). 2.2 Preparation and Administration Each kit of DEXYCU is for a single administration. After preparation, 0.005 mL will be administered. The DEXYCU administration kit contains the following items: One glass vial: 0.5 mL of DEXYCU One sterile 1-mL syringe One sterile syringe guide One sterile syringe ring One sterile 18-gauge needle (1½ inches long), plastic cap attached One sterile 25-gauge bent cannula (8 mm long), plastic cap attached Step 1. Prepare a sterile field. Remove the components of the administration kit from their respective pouches: syringe syringe guide syringe ring needle cannula Place onto the sterile field. Step 2. Withdraw the syringe plunger approximately 1 inch. Place the syringe ring on the plunger (slit facing the plunger). Apply slight downward pressure until the syringe ring "snaps" into place. Step 3. Place the 18-gauge needle firmly on the syringe. Remove the cap from the needle. Depress the plunger completely and then withdraw the plunger to fill the syringe with air. Step 4. Mix using a vortex mixer or vigorously shake the vial of DEXYCU sideways for a minimum of 30 seconds. The suspended drug material must be used immediately after shaking. Step 5. Remove the blue plastic flip-cap from the vial and wipe the top of rubber stopper with an alcohol pad. Invert the vial. Step 6. Insert the needle into the vial and inject the air into the vial. Making sure the needle tip is immersed in the drug material pooled in the neck of the inverted vial, fill the syringe by slowly withdrawing the plunger approximately 0.2 mL. Remove the needle from the vial and discard the unused portion in the vial. Step 7. Remove the needle from the syringe. Firmly place the cannula on the syringe and remove the plastic cap. Hold the syringe vertically with the cannula pointing up. Depress the plunger to expel air bubbles from syringe. Step 8. Affix the syringe guide over the syringe ring on the plunger. Step 9. Depress the plunger until the syringe guide/ring mechanism comes gently into contact with the flange of the syringe. Lightly tap/flick the barrel of the syringe to remove any excess drug from the tip of the cannula. Do not wipe or touch the tip of the cannula to remove excess drug. Step 10. Remove the syringe guide, leaving the syringe ring in place. Caution to not move the plunger. The space between the syringe ring and the top of the plunger is the medication injection volume that will be applied to the patient's eye. The syringe is now ready for injection. Step 11. In a single slow motion, inject 0.005 mL of the drug material behind the iris in the inferior portion of the posterior chamber. If the sphere of administered drug after intraocular injection appears to be larger than 2 mm in diameter, excess drug material may be removed by irrigation and aspiration in the sterile surgical setting PLEASE NOTE: Some drug material will remain in the syringe after the injection—this is necessary for accurate dosing. Discard unused portion remaining in the syringe after administration. Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Warnings and cautions 5 WARNINGS AND PRECAUTIONS Increase in Intraocular Pressure (IOP) : Monitor for increases in IOP ( 5.1 ). Delayed Healing : Monitor for delayed healing ( 5.2 ). Infection Exacerbation : Monitor and treat for any exacerbations of bacterial, viral or fungal infections ( 5.3 ). Cataract Progression : Cataracts may develop or progress in phakic patients ( 5.4 ). 5.1 Increase in Intraocular Pressure Prolonged use of corticosteroids including DEXYCU may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. 5.2 Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of corticosteroids. 5.3 Exacerbation of Infection The use of DEXYCU, as with other ophthalmic corticosteroids, is not recommended in the presence of most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infecti