About DUPIXENT

How Can DUPIXENT Help Your Teen?

What if there was a way to help manage the eczema symptoms that bother your teen the most?

DUPIXENT is the first treatment of its kind that can help achieve clearer skin in teens age 12-17 with moderate-to-severe eczema (atopic dermatitis). It reduces the inflammation underneath the surface that can contribute to the itching and rashes, and can help continuously manage your teen’s eczema, even after their skin looks clearer.

DUPIXENT Demonstrated Results and Safety

DUPIXENT was studied in a 16-week clinical trial with 251 patients* age 12-17 with moderate-to-severe eczema not adequately controlled with topical prescription treatments. The safety results of DUPIXENT observed in adolescents were consistent versus placebo with what was seen in adults with atopic dermatitis.

What you should know about the patients in this study:

  • 46% had moderate atopic dermatitis
  • 54% had severe atopic dermatitis
  • Average age ≈15 years old
  • Average body surface area involvement ≈57%
  • 92% had at least one co-morbid allergic condition

In a 16-week clinical trial with DUPIXENT when used alone compared to a placebo:

LESS ITCHING

On average, teens experienced significantly less itching in as little as 2 weeks with DUPIXENT

“For so long we’ve tried to treat eczema on the surface. I never thought the problem might be on the inside.”

Debbie

Parent of patient treated with DUPIXENT

CLEARER SKIN

Many teens experienced nearly 75% clearer skin in as little as 4 weeks

“I feel like I’ve tried everything to get my eczema under control, and it looks like I found something that works.”

Jessica, age 16

DUPIXENT MyWay® Patient Ambassador, treated with DUPIXENT

Individual result may vary

REDUCTION OF SYMPTOMS

2 in 3 teens saw a significant reduction of eczema symptoms over 16 weeks

“We talked it over, but the chance to control the itching and rashes easily outweighed giving the injection.”

Charlotte

Parent of patient treated with DUPIXENT

THE MOST COMMON SIDE EFFECTS include injection site reactions, pain in the throat (oropharyngeal pain), and cold sores in your mouth or on your lips. Eye and eyelid inflammation, including redness, swelling, and itching have been seen in patients who have atopic dermatitis.

*251 patients who were 12-17 years old with moderate-to-severe atopic dermatitis were randomized into one of three treatment groups for the controlled period of 16 weeks. The first group was treated with DUPIXENT subcutaneous injection 200 mg or 300 mg every two weeks, based on weight (with an initial dose of 400 mg or 600 mg, respectively). The second group was treated with 300 mg DUPIXENT every four weeks (with an initial dose of 600 mg), and the third group was treated with placebo every two weeks.

The overall rate of adverse events was comparable between the DUPIXENT groups and the placebo group (72% for DUPIXENT every two weeks, 64% for DUPIXENT every four weeks, and 69% for placebo.)

Connect With a Specialist
Who Treats Eczema

Consult with your teen’s doctor and then use this tool to easily find nearby specialists with experience in treating teens and adults with uncontrolled moderate-to-severe eczema (atopic dermatitis).

Sanofi US and Regeneron do not endorse or recommend any particular physician, and search results do not include a comprehensive list of doctors in your area.

How to Administer DUPIXENT

If your teen’s healthcare provider decides that you or your teen can give the injections of DUPIXENT, you or your teen should receive training on the right way to prepare and inject DUPIXENT. Do not try to inject DUPIXENT until you have been shown the right way by your healthcare provider.

Choose the video that fits your situation for supplemental information on how to use and dispose of DUPIXENT.

Hi there. I’m Laura.

Today I’m going to show you how to properly self-inject a dose of DUPIXENT(dupilumab).

You’ve already learned how to self- inject with your healthcare provider.

I’m here to guide your first at-home experience.

When I first started self-injections, I found syringes really intimidating. I’ve gotten better at the process since then, so I want to share those steps with you today.

I’ll show you: what supplies to gather, how to prep the injection area, and how to inject the dose and discard your used syringe.

If you haven’t yet read the instructions for use located in your treatment packaging, pause the video and take a look.

I found it helpful to understand the plunger, syringe body, and needle cap before handling the syringe itself.

Contact your healthcare provider or the DUPIXENT MyWay Hotline with any questions.

It’s time for me to take my DUPIXENT injection. Feel free to watch me and follow along as I self-inject.

Take your medication out of the refrigerator. Never freeze your syringe.

Remove the syringe by holding the middle of the syringe body.

Do not use the syringe if it has been dropped on a hard surface or is damaged.

Do not pull off the needle cap or touch the plunger rod until you are ready to inject.

Do not pull back on the plunger rod at any time.

Keep DUPIXENT syringes and all medicines out of the reach of children.

If you have an unused syringe, return it to the refrigerator in the original carton to protect it from light.

Your Dupixent pre-filled syringe may appear different than what I am using in this video, based on the prescribed dose. If you have questions about the dosage prescribed to you, please contact your healthcare provider.

Check the label to make sure the medication inside is correct and the expiration date has not passed. If it isn’t right, contact your pharmacy.

You may see an air bubble, this is normal. Do not try to get rid of any air bubbles.

The liquid inside should be clear, and colorless to pale yellow.

Do not use the syringe if the liquid is discolored or cloudy, or if it contains visible flakes or particles. Throw away, dispose of, the used Dupixent single- dose pre-filled syringe right away after use.

If you have any questions about whether the syringe is okay to use, please call the DUPIXENT MyWay Hotline, or your healthcare provider.

Lay the syringe on a flat surface and let it naturally warm to room temperature.

The recommended warming time for the 200mg syringe is 30 minutes, and for the 300mg syringe, it's 45 minutes.

Do not heat the syringe.

Do not put the syringe into direct sunlight.

Do not keep DUPIXENT at room temperature for more than 14 days. Throw away, dispose of, any syringe that has been left at room temperature for longer than 14 days.

Do not shake the syringe.

While you wait, gather the additional materials necessary to self-inject.

You need one cotton ball or gauze, one alcohol wipe, and a puncture resistant Sharps Disposal Container.

If you don’t have a Sharps Disposal Container, call a DUPIXENT MyWay representative to request a complimentary Sharps Disposal Container.

Now, take your supplies to an area where you can sit comfortably.

When you are ready to get started, wash your hands thoroughly.

Choose your injection site. Both the stomach and thigh are acceptable, except for the two inches around your belly button.

If a caregiver gives you the injection, the outer area of the upper arm is also an option. The person giving the injection should follow the same preparation procedure.

Be sure to choose a different site each time you inject DUPIXENT.

Do not inject through clothes.

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

Clean your skin with the alcohol wipe.

Do not touch the injection site again or blow on it before the injection. Let your skin dry before injection.

Hold the DUPIXENT syringe in the middle of the Syringe Body with the Needle pointing away from you and carefully remove the cap from the syringe.

Do not use if the needle cap is missing or not securely attached.

Do not put the needle cap back on.

Do not touch the needle. Inject the medicine right away after removing the Needle cap.

Pinch a fold of skin at the injection site. Pinching your skin helps the medicine go into a fatty layer, just below the skin, and not into the muscle.

Take a deep breath.

Continue to pinch, as you insert the needle completely at about a 45° angle.

Relax your pinch.

Push the plunger down slowly and steadily as far as it will go, until the syringe is empty.

You will feel some resistance. This is normal.

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.

You can also cover the site with a bandage.

Put your used Needles, DUPIXENT Syringes, and Needle Caps in a FDA-cleared Sharps Disposal Container right away after Use.

Do not dispose of needles, DUPIXENT Syringes, and Needle Caps in your household trash.

Follow your local guidelines and ask your healthcare provider for the appropriate way to dispose of the container once it is full.

Do not recycle your used Sharps Disposal Container.

Do not reuse the syringe.

If you would like to practice before doing the actual injection and you have received the DUPIXENT training kit from your doctor's office, you can practice the 45° injection angle with your training syringe and the angle aid, and you could always watch the video again.

Remember, do not use the angle-aid to administer an actual injection.

Be sure to keep track of your injection date and site.

Thank you for joining me today. Remember, you can re-watch this video as often as you like to refresh your memory.

Contact your healthcare provider or the DUPIXENT MyWay Hotline with any questions or concerns.

Injection Instructions

Administering DUPIXENT yourself may seem intimidating, but following the instructions below will help reinforce the steps your healthcare provider showed you. Do not try to inject DUPIXENT until you have been shown the right way by your healthcare provider.

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.

2

Prepare

Ensure you have the following:

  • DUPIXENT Pre-filled Syringe
  • 1 alcohol wipe*
  • 1 cotton ball or gauze*
  • Sharps Disposal Container* (See Step 13)

* Items not included in the carton

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.

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.

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.

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.

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.

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.

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 shows an example of pinching a fold of skin on your stomach.

10

Insert

  • Insert the Needle completely into the fold of the skin at about a 45-degree angle.

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.

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.
  • Do not put the Needle Cap back on.
  • Do not rub your skin after the injection.
  • Lightly press a cotton ball or gauze on the injection site if you see any blood.

13

Dispose

  • Put your used Needles, DUPIXENT Syringes and Needle Caps in an 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 an 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.

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