Vabysmo Patient Counseling Information

Instructions for Use: The following information is intended for healthcare professionals only.
Preparation for Administration: Before you start: Read all the instructions carefully before using Faricimab (Vabysmo).
The Faricimab (Vabysmo) kit includes a glass vial and transfer filter needle. The glass vial is for a single dose only. The filter needle is for single use only.
Faricimab (Vabysmo) should be stored refrigerated at temperatures between 2°C to 8°C (36°F to 46°F).
Do not freeze.
Do not shake.
Allow Faricimab (Vabysmo) to reach room temperature, 20°C to 25°C (68°F to 77°F) before proceeding with the administration. Keep the vial in the original carton to protect from light.
The Faricimab (Vabysmo) vial may be kept at room temperature for up to 24 hours.
The Faricimab (Vabysmo) vial should be inspected visually prior to administration. Faricimab (Vabysmo) is a clear to opalescent and colorless to brownish-yellow liquid solution.
Do not use if particulates, cloudiness, or discoloration are visible.
Do not use if the packaging, vial and/or transfer filter needle are expired, opened, or have been tampered with.
Use aseptic technique to carry out the preparation of the intravitreal injection.
Instructions for use of vial: 1. Gather the following supplies: One Faricimab (Vabysmo) vial (included); One sterile 5-micron blunt transfer filter needle 18-gauge x 1½ inch, 1.2 mm x 40 mm (included); One sterile 1 mL Luer lock syringe with a 0.05 mL dose mark (not included); One sterile injection needle 30-gauge x ½ inch (not included), note that a 30-gauge injection needle is recommended to avoid increased injection forces that could be experienced with smaller diameter needles; Alcohol swab (not included).
2. To ensure all liquid settles at the bottom of the vial, place the vial upright on a flat surface (for about 1 minute) after removal from packaging. Gently tap the vial with your finger, as liquid may stick to the top of the vial.
3. Remove the flip-off cap from the vial and wipe the vial septum with an alcohol swab.
4. Aseptically and firmly attach the included 18-gauge x 1½ inch transfer filter needle onto a 1 mL Luer lock syringe.
5. Using aseptic technique, push the transfer filter needle into the center of the vial septum, push it all the way in, then tilt the vial slightly so that the needle touches the bottom edge of the vial.
6. Hold the vial slightly inclined and slowly withdraw all the liquid from the vial. Keep the bevel of the transfer filter needle submerged in the liquid, to avoid introduction of air.
7. Ensure that the plunger rod is drawn sufficiently back when emptying the vial, in order to completely empty the transfer filter needle.
8. Disconnect the transfer filter needle from the syringe and dispose of it in accordance with local regulations.
Do not use the transfer filter needle for the intravitreal injection.
9. Aseptically and firmly attach a 30-gauge x ½ inch injection needle onto the Luer lock syringe.
10. Carefully remove the plastic needle shield from the needle by pulling it straight off.
11. To check for air bubbles, hold 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.
12. Carefully expel the air from the syringe and needle, and slowly depress the plunger to align the rubber stopper tip to the 0.05 mL dose mark. The syringe is ready for the injection. Ensure that the injection is given immediately after preparation of the dose.
Injection Procedure: Inject slowly until the rubber stopper reaches the end of the syringe to deliver the volume of 0.05 mL. Confirm delivery of the full dose by checking that the rubber stopper has reached the end of the syringe barrel.
Any waste material or unused medicinal product should be disposed of in accordance with local regulations.