Dupixent Patient Counseling Information

Important information: This device is a single-use pre-filled syringe. It contains 200 mg or 300 mg of Dupixent for injection under the skin (subcutaneous injection).
You must not try to give yourself or someone else the injection unless you have received training from your healthcare professional. In adolescents 12 years and older, it is recommended that Dupixent be administered by or under supervision of an adult. In children less than 12 years of age, Dupixent should be given by a caregiver.
Read all of the instructions carefully before using the syringe.
Check with your healthcare professional how often you will need to inject the medicine.
Ask your healthcare professional to show you the right way to use the syringe before you inject for the first time.
Change the injection site for each injection.
Do not use the syringe if it has been dropped on a hard surface or damaged.
Do not use the syringe if the needle cap is missing or not securely attached.
Do not touch the plunger rod until you are ready to inject.
Do not inject through clothes.
Do not get rid of any air bubbles in the syringe.
To help prevent accidental needle injury, each pre-filled syringe has a needle shield that is automatically activated to cover the needle after you have given your injection.
Never pull back on the plunger rod.
Do not re-use the syringe.
How to Store Dupixent: Keep the syringe(s) out of the reach of children.
Keep unused syringes in the original carton and store in the refrigerator between 2°C and 8°C.
Do not keep Dupixent at room temperature (<25°C) for more than 14 days. If you need to permanently remove the carton from the refrigerator, write down the date of removal in the space provided on the outer carton, and use Dupixent within 14 days.
Do not shake the syringe at any time.
Do not heat the syringe.
Do not freeze the syringe.
Do not place the syringe into direct sunlight.
Instructions for use: Step 1: Remove.
Remove the syringe from the carton by holding the middle of the syringe body.
Do not pull off the needle cap until you are ready to inject. Do not use the syringe if it has been dropped on a hard surface or damaged.
Step 2: Prepare.
Ensure you have the following: the Dupixent pre-filled syringe, 1 alcohol wipe*, 1 cotton ball or gauze*, a puncture-resistant container* (see Step 12 as follows).
* Items not included in the carton.
Look at the label: Check the expiry date. Check that you have the correct product and dose.
Do not use the syringe if the expiry date has passed. Do not keep Dupixent at room temperature for more than 14 days.
Step 3: Inspect.
Look at the medicine through the viewing window on the syringe: Check if the liquid is clear and colourless to pale yellow.
Note: You may see an air bubble; this is normal.
Do not use the syringe if the liquid is discoloured or cloudy, or if it contains flakes or particles.
Step 4: Wait 30 minutes (200 mg pre-filled syringe) or 45 minutes (300 mg pre-filled syringe).
Lay the 200 mg or 300 mg syringe on a flat surface for at least 30 minutes or 45 minutes, respectively, and let it get to room temperature naturally.
Do not warm the syringe in a microwave, hot water, or direct sunlight. Do not place the syringe in direct sunlight. Do not keep Dupixent at room temperature for more than 14 days.
Step 5: Choose.
Select the injection site. You can inject into your thigh or belly (stomach), except for the 5 cm around your navel. If somebody else gives you the injection, they can also use your upper arm. Change the injection site for each injection.
Do not inject into skin that is tender, damaged or has bruises or scars.
Step 6: Clean.
Wash your hands. Clean the injection site with an alcohol wipe. Let your skin dry before injecting.
Do not touch the injection site again or blow on it before the injection.
Step 7: Pull.
Hold the syringe in the middle of the syringe body with the needle pointing away from you and pull off the needle cap.
Do not put the needle cap back on. Do not touch the needle.
Inject your medicine immediately after removing the needle cap.
Step 8: Pinch.
Pinch a fold of skin at the injection site.
Step 9: Insert.
Insert the needle completely into the fold of skin at roughly a 45° angle.
Step 10: Push.
Relax the pinch. Push the plunger rod down slowly and steadily as far as it will go until the syringe is empty.
Note: You will feel some resistance. This is normal.
Step 11: Release and Remove.
Lift your thumb to release the plunger rod until the needle is covered by the needle shield and then remove the syringe from the injection site. Lightly press a cotton ball or gauze on the injection site if you see any blood.
Do not put the needle cap back on. Do not rub your skin after the injection.
Step 12: Dispose.
Dispose of the syringe and the needle cap in a puncture-resistant container.
Do not put the needle cap back on.