Entyvio Caution For Usage

INSTRUCTIONS FOR USE AND HANDLING AND DISPOSAL: Vedolizumab does not contain preservatives. Once reconstituted, the infusion solution should be used as soon as possible.
Instructions for reconstitution and infusion: 1. Use aseptic technique when preparing Entyvio solution for intravenous infusion.
2. Remove flip-off cap from the vial and wipe with alcohol swab. Reconstitute Entyvio with 4.8 mL of sterile water for injection at room temperature (20°C - 25°C), using a syringe with a 21-25 gauge needle.
3. Insert the syringe needle into the vial through the center of the stopper and direct the stream of sterile water for injection to the wall of the vial to avoid excessive foaming.
4. Gently swirl the vial for at least 15 seconds. Do not vigorously shake or invert.
5. Let the vial sit for up to 20 minutes at room temperature (20°C - 25°C) to allow for reconstitution and for any foam to settle; the vial can be swirled and inspected for dissolution during this time. If not fully dissolved after 20 minutes, allow another 10 minutes for dissolution. Do not use the vial if the drug product is not dissolved within 30 minutes.
6. Inspect the reconstituted solution visually for particulate matter and discoloration prior to dilution. Solution should be clear or opalescent, colorless to light yellow and free of visible particulates. Reconstituted solution with uncharacteristic color or containing particulates must not be administered.
7. Once dissolved, gently invert vial 3 times.
8. Immediately withdraw 5 mL (300 mg) of reconstituted Entyvio using a syringe with a 21-25 gauge needle.
9. Add the 5 mL (300 mg) of reconstituted Entyvio to 250 mL of sterile 0.9% sodium chloride solution or 250 mL of Lactated Ringer's solution, and gently mix the infusion bag (5 mL of solution does not have to be withdrawn from the infusion bag prior to adding Entyvio). Do not add other medicinal products to the prepared infusion solution or intravenous infusion set. Administer the infusion solution over 30 minutes.
Do not store any unused portion of the reconstituted solution or infusion solution for reuse. Each vial is for single-use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.