DEXYCU (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation.
DOSAGE AND ADMINISTRATION
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).
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
Prepare a sterile field. Remove the components of the administration kit from their respective pouches:
- syringe guide
- syringe ring
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.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 no 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 patientâ€™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 injectionâ€” this is necessary for accurate dosing. Discard unused portion remaining in the syringe after administration.
Dosage Forms And Strengths
DEXYCU contains dexamethasone 9% w/w (103.4 mg/mL) as a sterile suspension for intraocular ophthalmic administration. DEXYCU is provided as a kit for administration of a single dose of 0.005 mL of 9% dexamethasone (equivalent to 517 micrograms of dexamethasone).
Storage And Handling
Each kit of DEXYCU contains a single dose for a single patient. The 2-mL glass vial is filled with 0.5 mL of 9% dexamethasone intraocular suspension and has a blue cap (NDC # 71879-001-01).
Each kit also contains one sterile 18-gauge, 1.5-inch needle with a plastic cap attached, one sterile plastic 1-mL syringe for withdrawal of the vial contents, one sterile 25-gauge 8-mm cannula with a plastic cap attached for the intraocular administration, and one syringe assembly pouch containing a sterile ring and a sterile syringe guide used for measuring and injection of the 0.005 mL dose.
Store at 20°C to 25°C (68°F to 77°F).
Manufactured for: EyePoint Pharmaceuticals US, Inc. Watertown, MA 02472. Revised: Dec 2018