IZERVAY Intravitreal solution Ref.[107401] Active ingredients: Avacincaptad pegol

2.1 General Dosing Information

IZERVAY must be administered by a qualified physician.

2.2 Recommended Dosage

The recommended dose for IZERVAY is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection to each affected eye once monthly (approximately every 28 ± 7 days) for up to 12 months.

2.3 Preparation for Administration

Important information you should know before you begin:

• Read all the instructions carefully before using IZERVAY.
• The IZERVAY kit includes a glass vial, filter needle, and an empty syringe. The glass vial, filter needle, and empty syringe are for single use only.
• Store IZERVAY in the refrigerator at temperatures between 2ºC to 8ºC (36ºF to 46ºF). Do not freeze. Do not shake.
• Prior to use, allow IZERVAY to reach room temperature, 20⁰C to 25⁰C (68⁰F to 77⁰F). The IZERVAY vial may be kept at room temperature for up to 24 hours. Keep the vial in the original carton to protect from light.
• Use aseptic technique to carry out the preparation of the intravitreal injection.
• Each vial should only be used for the treatment of a single eye.

Step 1: Gather Supplies

Gather the following supplies (see Figure A):

• One IZERVAY vial (included)
• One sterile 5-micron filter needle 19-gauge x 1½ inch (included)
• One sterile 1 mL Luer lock syringe with a 0.1 mL dose mark (included)
• One sterile injection needle 30-gauge x ½ inch (not included)
  NOTE: a 30-gauge injection needle is recommended to avoid increased injection forces that could be experienced with smaller diameter needles.
• Alcohol swab (not included)

Step 2: Inspect Vial

Inspect the liquid in the vial. It should be a clear to slightly opalescent, colorless to slightly yellow liquid solution (see Figure B).

Do not use if particulates, cloudiness, or discoloration are visible.

Do not use if the packaging, vial, filter needle, injection needle, and/or empty syringe are expired, damaged, or have been tampered with.

Step 3: Orient Vial

Place the vial upright on a flat surface for about 1 minute after removal from packaging to make sure all liquid settles at the bottom of the vial (see Figure C).

Gently tap the vial with your finger to remove any liquid that may stick to the top of the vial (see Figure D).

Step 4: Clean Vial

Remove the flip-off cap from the vial (see Figure E). Gently wipe the vial septum with an alcohol swab (see Figure F).

Step 5: Attach Filter Needle

Using aseptic technique, firmly attach the included 19-gauge x 1½ inch filter needle onto the 1 mL Luer lock syringe and twist clockwise to secure (see Figure G)

Step 6: Insert Filter Needle into Vial

Using aseptic technique, push the filter needle all the way into the center of the vial septum (see Figure H).

Tilt the vial slightly so that the needle touches the bottom edge of the vial (see Figure I).

Rotate the filter needle so that the bevel is submerged into the liquid to avoid introduction of air.

Step 7: Withdraw Liquid

Slowly withdraw all the liquid from the vial (see Figure J). Draw the plunger rod back far enough to completely empty the filter needle.

Step 8: Disconnect Filter Needle

Disconnect the filter needle from the syringe and dispose of it in accordance with local regulations (see Figure K).

Do not use the filter needle for the intravitreal injection.

Step 9: Attach Injection Needle

Using aseptic technique, firmly attach the 30-gauge x ½ inch injection needle onto the Luer lock syringe. (see Figure L).

Carefully remove the plastic needle shield from the needle by pulling it straight off (see Figure M).

Step 10: Check Syringe

Check for air bubbles by holding the syringe with the needle pointing up. If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure N).

Step 11: Prepare Appropriate Dose

Slowly depress the plunger to:

• Expel the air from the syringe
• Align the rubber stopper tip to the 0.1 mL dose mark.

The syringe is now ready for the injection (see Figure O).

Make sure to give the injection immediately after preparing the dose.

2.4 Injection Procedure

Only 0.1 mL (2 mg) should be administered to deliver a single dose. Any excess volume should be disposed.

Prior to the intravitreal injection, patients should be monitored for elevated intraocular pressure (IOP) using tonometry [see Warnings and Precautions (5.3)]. If necessary, ocular hypotensive medication can be given to lower the IOP.

The intravitreal injection procedure must be carried out under controlled aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum topical microbicide should be given prior to the injection.

Inject slowly until the rubber stopper reaches the end of the syringe to deliver the volume of 0.1 mL. Confirm delivery of the full dose by checking that the rubber stopper has reached the end of the syringe barrel.

Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure (IOP). Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry.

Following intravitreal injection, patients should be instructed to report any symptoms suggestive of endophthalmitis (e.g., eye pain, redness of the eye, photophobia, blurring of vision) without delay [see Patient Counseling Information (17)].

Each vial and syringe should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial and syringe should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter needle, and injection needle should be changed before IZERVAY is administered to the other eye. Repeat the same procedure steps as above.

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

Store IZERVAY in the refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake. Keep the vial in the original carton to protect from light.

Prior to use, the unopened glass vial of IZERVAY may be kept at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours. Ensure that the injection is given immediately after preparation of the dose.