Vabysmo Caution For Usage

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: Do not shake.
Vabysmo should be inspected visually upon removal from the refrigerator and prior to administration. If particulates or cloudiness are visible, Vabysmo must not be used.
Vial: The vial contains more than the recommended dose of 6 mg. The fill volume of the vial (0.24 mL) is not to be used in total. The excess volume should be expelled prior to injection. Injecting the entire volume of the vial results in overdose. The injection dose must be set to the 0.05 mL dose mark, i.e. 6 mg faricimab.
The contents of the vial and the transfer filter needle are sterile and for single use only.
Pre-filled syringe: The pre-filled syringe is for single use in one eye only. Open the sterile pre-filled syringe under aseptic conditions only. The solution should be inspected visually prior to administration. If particulates or cloudiness are visible, the pre-filled syringe must not be used.
The pre-filled syringe contains more than the recommended dose of 6 mg faricimab (equivalent to 0.05 mL). Each pre-filled syringe contains 21 mg faricimab in 0.175 mL solution. The excess volume must be expelled prior to injection.
Do not use if the packaging, vial/pre-filled syringe and/or transfer/injection filter needle are damaged or expired. Detailed instructions for use are provided in Instructions for use of vial and Instructions for use of pre-filled syringe as follows.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Instructions for use of vial: Gather supplies: 1. Gather the following supplies: One 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); Alcohol swab (not included). Note that a 30-gauge injection needle is recommended to avoid increased injection forces that could be experienced with smaller diameter needles.
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 the 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.
Transfer medicinal product from vial to syringe: 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.
Attach injection needle: 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.
Dislodge air bubbles and adjust medicinal product dose: 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 the 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.
13. 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. Excess volume should be expelled prior to injection. The injection dose must be set to the 0.05 mL dose mark to avoid overdose. Any waste material or unused medicinal product should be disposed of in accordance with local regulations.
Instructions for use of pre-filled syringe: Open tray and remove syringe cap: 1. Peel the lid off the syringe tray and aseptically remove the pre-filled syringe.
2. Hold the syringe by the white collar; snap off the syringe cap.
Do not twist off the cap.
Attach injection filter needle: 3. Aseptically remove the injection filter needle from its packaging.
4. Aseptically and firmly attach the injection filter needle onto the syringe Luer lock.
Only use the provided injection filter needle for the administration.
5. Carefully remove the needle cap by pulling it straight off.
Dislodge air bubbles: 6. Hold the syringe with the injection filter needle pointing up. Check the syringe for air bubbles.
7. If there are any air bubbles, gently tap the syringe with the finger until the bubbles rise to the top.
Adjust medicinal product dose and expel air: 8. Hold the syringe at eye level and slowly push the plunger rod until the lower edge of the rubber stopper's dome is aligned with the 0.05 mL dose mark. This will expel the air and the excess solution and set the dose to 0.05 mL.
Ensure that the injection is given immediately after preparation of the dose.
Injection procedure: 9. The injection procedure should be carried out under aseptic conditions.
Inject slowly until the rubber stopper reaches the bottom of the syringe to deliver the volume of 0.05 mL.
Do not recap or detach the injection filter needle from the syringe.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.