Dupixent Instructions for Use Pre-Filled Syringe 300mg

How should I store DUPIXENT?

• Keep DUPIXENT Syringes and all medicines out of the reach

of children.

• Store DUPIXENT Syringes in the refrigerator between 36°F to

46°F (2°C to 8°C).

• Store DUPIXENT Syringes in the original carton to protect them

from light.

• DUPIXENT Syringes can be stored at room temperature up

to 77°F (25°C) up to 14 days. Throw away (dispose of) any

DUPIXENT Syringes that have been left at room temperature for

longer than 14 days.

• Do not shake the DUPIXENT Syringe.

• Do not heat the DUPIXENT Syringe.

• Do not freeze the DUPIXENT Syringe.

• Do not put the DUPIXENT Syringe into direct sunlight.

INSTRUCTIONS FOR USE

DUPIXENT

(DU-pix-ent)

(dupilumab)

injection, for subcutaneous use

Single-Dose Pre-ﬁlled Syringe with Needle Shield

Read this Instructions for Use before using the DUPIXENT Pre-ﬁlled

Syringe. Do not inject yourself or someone else until you have been

shown how to inject DUPIXENT. Your healthcare provider can show

you or your caregiver how to prepare and inject a dose of DUPIXENT

before you try to do it yourself the ﬁrst time. Keep these instructions for

future use. Call your healthcare provider if you have any questions.

This device is a Single-Dose Pre-ﬁlled Syringe (called “DUPIXENT

Syringe” in these instructions). It contains 300 mg of DUPIXENT for

injection under the skin (subcutaneous injection).

The parts of the DUPIXENT Syringe are shown below:

Important Information

• Read all of the instructions

carefully before using the

DUPIXENT Syringe.

• Ask your healthcare provider

how often you will need to

inject the medicine.

• In children 12 years of age

and older, it is recommended

that DUPIXENT be

administered by or under

supervision of an adult.

• In children 6 months to

less than 12 years of age,

DUPIXENT should be given

by a caregiver.

• Rotate the injection site each

time you inject.

• Do not use the DUPIXENT

Syringe if it has been

dropped on a hard surface or

damaged.

• Do not use the DUPIXENT

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

bubble in the DUPIXENT

Syringe.

• To reduce the risk of

accidental needle sticks,

each pre-ﬁlled syringe has

a Needle Shield that is

automatically activated to

cover the needle after you

have given your injection.

• Do not pull back on the

Plunger Rod at any time.

• Do not remove the Needle

Cap until just before you give

the injection.

• Throw away (dispose of) the

used DUPIXENT Single-Dose

Pre-ﬁlled Syringe right away

after use. See “Step 13:

Dispose” below.

• Do not re-use a DUPIXENT

Single-Dose Pre-ﬁlled

Syringe

Step 1: Remove

Remove the DUPIXENT 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 DUPIXENT 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 sharps disposal container* (See Step 13)

*Items not included in the carton

Step 3: Check

When you receive your DUPIXENT Syringes, always check to see

that:

• you have the correct medicine and dose.

• the expiration date on the Single-Dose Pre-ﬁlled Syringe has not

passed.

Do not use the DUPIXENT Syringe if the expiration date has

passed.

Step 8: Remove Needle Cap

Hold the DUPIXENT 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 right away after removing the Needle Cap.

Step 7: 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 4: Inspect

Look at the medicine through the Viewing Window on the DUPIXENT

Syringe:

Check to see if the liquid is clear and colorless to pale yellow.

Note: You may see an air bubble, this is normal.

Do not use the DUPIXENT Syringe if the liquid is discolored

or cloudy, or if it contains visible ﬂakes or particles.

Step 5: Wait 45 minutes

Lay the DUPIXENT Syringe on a ﬂat surface and let it naturally warm

to room temperature for at least 45 minutes.

Do not heat the DUPIXENT Syringe.

Do not put the DUPIXENT Syringe into direct sunlight.

Do not keep DUPIXENT Syringes at room temperature for

more than 14 days. Throw away (dispose of) any DUPIXENT

Syringes that have been left at room temperature for longer

than 14 days.

Step 6: Choose your injection site

• You can inject into your thigh or stomach, except for the 2 inches

(5 cm) around your belly button (navel).

• If a caregiver injects your dose, they can also use the outer area

of the upper arm.

• Choose a different site each time you inject DUPIXENT.

Do not inject into skin that is tender, damaged, bruised or

scarred.

Step 9: Pinch

Pinch a fold of skin at the injection site (thigh or stomach, except 2

inches around your belly button, or outer area of the upper arm if

injected by your caregiver). The ﬁgure below shows an example of

pinching a fold of skin on your stomach.

Step 10: Insert

Insert the Needle completely into the fold of the skin at about a 45º

angle.

Step 11: Push

Relax the pinch.

Push the Plunger Rod down slowly and steadily as far as it will go

until the DUPIXENT Syringe is empty.

Note: You will feel some resistance. This is normal.

Step 12: 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 13: Dispose

Put your used Needles, DUPIXENT Syringes, and Needle Caps in a

FDA-cleared sharps disposal container right away after use.

Do not dispose of (throw away) Needles, DUPIXENT

Syringes, and Needle Caps in your household trash.

If you do not have a FDA-cleared sharps disposal container, you may

use a household container that is:

• made of a heavy-duty plastic,

• can be closed with a tight-ﬁtting, puncture-resistant lid, without

sharps being able to come out,

• upright and stable during use,

• leak-resistant, and

• properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to

follow your community guidelines for the right way to dispose of your

sharps disposal container. There may be state or local laws about

how you should throw away used Needles and Syringes.

For more information about safe sharps disposal, and for speciﬁc

information about sharps disposal in the state that you live in, go to

the FDA’s website at: http://www.fda.gov/safesharpsdisposal

Do not dispose of your used sharps disposal container in your

household trash unless your community guidelines permit this. Do

not recycle your used sharps disposal container.

Do not put the Needle Cap back on.

Manufactured by:

Regeneron Pharmaceuticals, Inc.

Tarrytown, NY 10591

U.S. License No. 1760

Marketed by:

sanoﬁ-aventis U.S. LLC (Bridgewater, NJ 08807) and

Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591)

DUPIXENT

is a registered trademark of Sanoﬁ Biotechnology

This Instructions for Use has been approved by the U.S. Food and

Drug Administration.

Revised: July 2023

US.DUP.24.04.0255