Entyvio Patient Counseling Information

Solution for injection: Instructions for Use: Important Information: Read and follow these Instructions for Use before you inject. A healthcare provider should show you how to use the ENTYVIO pre-filled pen before you use it for the first time.
Do not put or press thumb, fingers or hand over the yellow needle shield.
If you have any questions or concerns about ENTYVIO prefilled pen, call a healthcare provider.
Storage: Refrigerate at 2°C to 8°C.
If needed, for example when you are traveling, the prefilled pen/autoinjector can be left in its box at room temperature up to 25°C for up to 7 days.
Do not freeze.
Do not leave in direct sunlight.
1) Place what you need for the injection on a clean, flat surface: Take the pre-filled pen carton out of the refrigerator.
If you are opening the carton for the first time, check to make sure the carton is properly sealed. Do not use the pre-filled pen(s) if any of the seals on the carton are broken or missing.
Check the expiry date (EXP) on the box. Do not use if the expiration date on the carton has passed.
Remove one pre-filled pen from the carton. Keep any remaining pre-filled pens in the carton in the refrigerator.
Wait 30 minutes to let the pre-filled pen come to room temperature.
Do not warm the pre-filled pen in any other way.
Do not let it sit in direct sunlight.
Do not take the pre-filled pen out of its tray until you are ready to inject.
You will also need: Alcohol pad, Cotton ball or gauze, Sharps disposal container.
2) Open and check the pre-filled pen: Wash your hands.
Peel back the paper on the tray and lift the pre-filled pen out.
Inspect the pre-filled pen for damage.
Do not use the pre-filled pen if any part of it is damaged.
Check the expiry date on the pre-filled pen.
Do not use if the expiry date on the pre-filled pen has passed.
Check the medicine. It should be colorless to yellow.
Do not use the pre-filled pen if the medicine is cloudy or has particles floating in it.
You may see air bubbles in the pre-filled pen. This is normal.
Do not shake.
3) Prepare the injection site: Choose an injection site on your bare skin from one of the following: Front of the thighs, or Stomach area (abdomen) except for the area 2 inches (5 cm) around the belly button (navel), or Back of the upper arm (only if a caregiver gives the injection).
Use a new injection site or a different area within the same injection site for each injection.
Do not inject into moles, scars, bruises, or skin that is tender, hard, red, or damaged.
Wipe the chosen site with an alcohol pad. Let the skin dry.
Do not touch this area again before you inject.
Pull the purple cap straight off and throw it away.
Do not put or press thumb, fingers or hand over the yellow needle shield.
Do not re-cap the pre-filled pen.
Do not use a dropped pre-filled pen.
4) Inject ENTYVIO: Hold the pre-filled pen so you can see the viewing window.
Place the pre-filled pen at 90 degrees to the injection site.
Be sure the yellow end is toward the injection site.
Do not push down until you are ready to inject.
Push down on the pre-filled pen as far as it will go to begin the injection.
Hold and count to 10 while pushing down with constant pressure. This will allow all of the medicine to be injected.
You may hear two clicks, one at the start and one near the end of the injection.
Confirm that the viewing window is filled with purple before you stop pushing.
You will see a small amount of grey in the window. This is normal.
Lift the pre-filled pen from the injection site.
The yellow needle shield will drop down and lock over the needle.
If the viewing window did not fill completely, call your healthcare provider. You may not have received the full dose of medicine.
You may see a small amount of blood at the injection site. If you do, press on the skin with a cotton ball or gauze.
5) Throw away used material: Put the used pre-filled pen in a a puncture-resistant container, like a sharps container, immediately after use.
Dispose of your sharps container according to your local regulations.
The rest of the material can be thrown away in your household rubbish.