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Dupixent

Generic name: dupilumab
Drug class: Interleukin inhibitors

Medically reviewed by  A Ras MD.

What is Dupixent?

Dupixent is a prescription medicine used to treat people aged 6 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies.

Dupixent can be used with or without topical corticosteroids, with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. Dupixent helps prevent severe asthma attacks (exacerbations) and can improve your breathing.

Dupixent may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing, with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled.

Dupixent is not used to treat sudden breathing problems. Dupixent works by blocking two proteins that contribute to a type of inflammation that plays a major role in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. It is not known if Dupixent is safe and effective in children with atopic dermatitis under 6 years of age. It is not known if Dupixent is safe and effective in children with asthma under 12 years of age. It is not known if Dupixent is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.

Description

Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa.

Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture.

DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex.

Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9.

Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9.

Each 100 mg pre-filled syringe delivers 100 mg dupilumab in 0.67 mL which also contains L-arginine hydrochloride (3.5 mg), L-histidine (2.1 mg), polysorbate 80 (1.3 mg), sodium acetate (0.7 mg), sucrose (34 mg), and water for injection, pH 5.9.

Mechanism of Action

Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor.

Inflammation driven by IL-4 and IL-13 is an important component in the pathogenesis of asthma, atopic dermatitis, CRSwNP, and EoE. Multiple cell types that express IL-4Rα (e.g., mast cells, eosinophils, macrophages, lymphocytes, epithelial cells, goblet cells) and inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines, chemokines) are involved in inflammation. Blocking IL-4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. The mechanism of dupilumab action has not been definitively established.

Who should not use Dupixent?

Do not use Dupixent if you are allergic to dupilumab or to any of the ingredients in Dupixent. See the end of this guide for a complete list of ingredients in Dupixent.

What should I tell my healthcare provider before using Dupixent?

Before using Dupixent, tell your healthcare provider about all your medical conditions, including if you:

  • have eye problems
  • have a parasitic (helminth) infection
  • are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with Dupixent.
  • are pregnant or plan to become pregnant. It is not known whether Dupixent will harm your unborn baby.
    Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who take Dupixent during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-877-311-8972 or going to https://mothertobaby.org/ongoing-study/Dupixent/.
  • are breastfeeding or plan to breastfeed. It is not known whether Dupixent passes into your breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you:

  • are taking oral, topical, or inhaled corticosteroid medicines
  • have asthma and use an asthma medicine
  • have atopic dermatitis or CRSwNP, and also have asthma

Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to come back.

How should I use Dupixent?

  • See the detailed Instructions for Use that comes with Dupixent for information on how to prepare and inject Dupixent and how to properly store and throw away (dispose of) used Dupixent pre-filled syringes and pre-filled pens.
  • Use Dupixent exactly as prescribed by your healthcare provider.
  • Your healthcare provider will tell you how much Dupixent to inject and how often to inject it.
  • Dupixent comes as a single-dose pre-filled syringe with needle shield or as a pre-filled pen.
  • Dupixent is given as an injection under the skin (subcutaneous injection).
  • If your healthcare provider decides that you or a caregiver can give the injections of Dupixent, you or your caregiver 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. In children 12 years of age and older, it is recommended that Dupixent be given by or under the supervision of an adult. In children younger than 12 years of age, Dupixent should be given by a caregiver.
  • If your dose schedule is every other week and you miss a dose of Dupixent: Give the Dupixent injection within 7 days from the missed dose, then continue with your original schedule. If the missed dose is not given within 7 days, wait until the next scheduled dose to give your Dupixent injection.
  • If your dose schedule is every 4 weeks and you miss a dose of Dupixent: Give the Dupixent injection within 7 days from the missed dose, then continue with your original schedule. If the missed dose is not given within 7 days, start a new every 4 week dose schedule from the time you remember to take your Dupixent injection.
  • If you inject more Dupixent than prescribed, call your healthcare provider right away.
  • Your healthcare provider may prescribe other medicines to use with Dupixent. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the possible side effects of Dupixent?

Dupixent can cause serious side effects, including:

  • Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using Dupixent and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
    • breathing problems
    • fever
    • general ill feeling
    • swollen lymph nodes
    • swelling of the face, mouth, and tongue
    • hives
    • itching
    • fainting, dizziness, feeling lightheaded (low blood pressure)
    • joint pain
    • skin rash
  • Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.
  • Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive Dupixent. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by Dupixent. Tell your healthcare provider right away if you have:
    • rash
    • shortness of breath
    • persistent fever
    • chest pain
    • a feeling of pins and needles or numbness of your arms or legs

The most common side effects of Dupixent include:

  • injection site reactions
  • eye and eyelid inflammation, including redness, swelling, and itching
  • pain in the throat (oropharyngeal pain)
  • cold sores in your mouth or on your lips
  • high count of a certain white blood cell (eosinophilia)
  • trouble sleeping (insomnia)
  • toothache
  • gastritis
  • joint pain (arthralgia)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of Dupixent.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Dupixent

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information guide. Do not use Dupixent for a condition for which it was not prescribed. Do not give Dupixent to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Dupixent that is written for health professionals.

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 and 46°F (2°C and 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.

What are the ingredients in Dupixent?

Active ingredient: dupilumab

Inactive ingredients: L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection.

For more information about Dupixent, go to www.DUPIXENT.com or call 1-844-DUPIXENT (1-844-387-4936).

Instructions for use for Dupixent

  • Dupixent 300mg single-dose pre-filled syringe
  • Dupixent 200mg single-dose pre-filled syringe
  • Dupixent single-dose pre-filled pens (300 mg/2 mL)

Dupixent 300mg single-dose pre-filled syringe

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. In adolescents 12 years of age and older, it is recommended that Dupixent be administered by or under supervision of an adult. 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:

Dupixent syringe parts image. Before use: Plunger rod, finger grip, label, viewing window, syringe body, needle and needle cap. After use: plunger rod, needle and needle shield.

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.
  • 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.

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.

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.

Remove the Dupixent syringe from the carton by holding the middle of the syringe body.

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

Prepare the items you need. These include the syringe, 1 alcohol wipe, 1 cotton ball or gauze and a sharps disposal container.

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.

Do not use the dupixent syringe if the expiration date has passed. Always check you have the correct medication and dose.

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.

Look at the medicine through the viewing window and check to see if the liquid is clear and colorless to pale yellow.

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.

Lay the dupixent syringe on a flat surface and let it naturally warm to room temperature for at least 45 minutes.

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.

Choose your injection site. You can inject into your thigh or stomach, except for the 2 inches around your belly button. If someone else is injecting it into you they can also administer the injection into the outer upper arm.

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.

Clean the injection site with an alcohol wipe.

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.

Hold the Dupixent syringe in the middle of the syringe body with the needle pointing away from you and pull off the needle cap.

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.

Pinch a fold of skin at the injection site that can be thigh or stomach or outer area of the upper arm if injected by your caregiver.

Step 10: Insert

Insert the needle completely into the fold of the skin at about a 45° angle.

Insert the needle completely into the fold of the skin at about a 45° 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.

Relax the pinch and push the plunger rod down slowly and steadily as far as it will go until the dupixent syringe is empty.

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.

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.

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.

Put your used needles and dupixent syringes and needle caps in a fda-cleared sharps disposal container right away after use.

Instructions for use last updated May 2020.

Dupixent 200mg single-dose pre-filled syringe

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. In adolescents 12 years of age and older, it is recommended that Dupixent be administered by or under supervision of an adult. 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 200 mg of Dupixent for injection under the skin (subcutaneous injection).

The parts of the Dupixent syringe are shown below:

Dupixent syringe parts image. Before use: Plunger rod, finger grip, label, viewing window, syringe body, needle and needle cap. After use: plunger rod, needle and needle shield.

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.
  • 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.

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.

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.

Remove the Dupixent syringe from the carton by holding the middle of the syringe body.

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

Prepare the items you need. These include the syringe, 1 alcohol wipe, 1 cotton ball or gauze and a sharps disposal container.

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.

Do not use the dupixent syringe if the expiration date has passed. Always check you have the correct medication and dose.

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.

Look at the medicine through the viewing window and check to see if the liquid is clear and colorless to pale yellow.

Step 5: Wait 30 minutes

Lay the Dupixent Syringe on a flat surface and let it naturally warm to room temperature for at least 30 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.

Lay the Dupixent Syringe on a flat surface and let it naturally warm to room temperature for at least 30 minutes.

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.

Choose your injection site. You can inject into your thigh or stomach, except for the 2 inches around your belly button. If someone else is injecting it into you they can also administer the injection into the outer upper arm.

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.

Clean the injection site with an alcohol wipe.

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.

Hold the Dupixent syringe in the middle of the syringe body with the needle pointing away from you and pull off the needle cap.

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.

Pinch a fold of skin at the injection site that can be thigh or stomach or outer area of the upper arm if injected by your caregiver.

Step 10: Insert

Insert the needle completely into the fold of the skin at about a 45° angle.

Insert the needle completely into the fold of the skin at about a 45° 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.

Relax the pinch and push the plunger rod down slowly and steadily as far as it will go until the dupixent syringe is empty.

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.

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.

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.

Put your used needles and dupixent syringes and needle caps in a fda-cleared sharps disposal container right away after use.

Instructions for use last revised 05/2020.

Dupixent single-dose pre-filled pen (300mg/2 mL)

Read this Instructions for Use before using the Dupixent Pre-filled Pen. 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 for the first time. Keep this Instructions for Use. Call your healthcare provider if you have any questions.

This Dupixent Pre-filled Pen is only for use in adults and children aged 12 years and older.

This Dupixent Pre-filled Pen is a single-dose device. It contains 300 mg of Dupixent for injection under the skin (subcutaneous injection).

The parts of the Dupixent Pre-filled Pen are shown below:

Dupixent pre-filled pen before and after injection with green cap, window showing medicine and label. Green cap is removed for injection revealing yellow needle cover. Window shows yellow when injection complete.

Important Information

  • Read all of the instructions carefully before using the Dupixent Pre-filled Pen.
  • Ask your healthcare provider how often you will need to inject the medicine.
  • In adolescents 12 years of age and older, it is recommended that Dupixent be administered by or under supervision of an adult.
  • Choose a different injection site for each injection.
  • Do not press or touch the Yellow Needle Cover with your fingers.
  • Do not inject through clothes.
  • Do not remove the Green Cap until just before you give the injection.
  • Do not try to put the Green Cap back on the Dupixent Pre-filled Pen.
  • Throw away (dispose of) the used Dupixent Pre-filled Pen right away after use.
  • Do not re-use a Dupixent Pre-filled Pen.

Storing Dupixent

  • Store unused Dupixent Pre-filled Pens in the refrigerator between 36ºF and 46ºF (2ºC and 8ºC).
  • Store Dupixent Pre-filled Pens in the original carton to protect from light.
  • If necessary, you may keep Dupixent Pre-filled Pens at room temperature up to 77ºF (25ºC) for up to 14 days.
  • Do not store Dupixent Pre-filled Pens at room temperature more than 77ºF.
  • After removing a Dupixent Pre-filled Pen from the refrigerator, it must be used within 14 days or thrown away (disposed of).
  • Do not shake the Dupixent Pre-filled Pen at any time.
  • Do not heat the Dupixent Pre-filled Pen.
  • Do not freeze the Dupixent Pre-filled Pen.
  • Do not put the Dupixent Pre-filled Pen into direct sunlight.
  • Keep Dupixent Pre-filled Pens and all medicines out of the reach of children.

A. Get ready to inject

A1. Gather supplies

Find a clean, flat work surface. Make sure you have the following supplies:

Gather supplies including the Dupixent pre-filled pen, 1 alcohol wipe, 1 cotton ball or gauze and a sharps disposal container.

A2. Check the Pen

  • Do not use the Dupixent Pre-filled Pen if it has been damaged.
  • Do not use the Dupixent Pre-filled Pen if the Green Cap is missing or not securely attached.
  • Do not use the Dupixent Pre-filled Pen if the Window is yellow before use.

Do not use the Dupixent pre-filled pen if it has been damaged or the Window is yellow before you use it.

A3. Look at the Label

  • Check to be sure that you have the correct Medicine and dose.

Check your Dupixent pre-filled pen to make sure you have the correct medicine and dose.

  • Check the expiration date.
  • Image Do not use the Dupixent Pre-filled Pen if the expiration date has passed.

Check the expiration date on your Dupixent pre-filled pen to make sure it has not expired.

A4. Check the Medicine

  • Look at the Medicine through the Window: it should be clear and colorless to pale yellow.
  • Note: You may see an air bubble, this is normal.
  • Do not use the Dupixent Pre-filled Pen if the liquid is discolored or cloudy, or if it contains visible flakes or particles.

Check the window on your Dupixent pre-filled pen to make sure the liquid is clear and colorless to pale yellow. Do not use if it is cloudy, discolored or has flakes or particles in it.

A5. Wait 45 minutes

  • Lay the Dupixent Pre-filled Pen on a flat surface and let it warm up at room temperature less than 77ºF (25ºC) for at least 45 minutes.
  • Do not heat the Dupixent Pre-filled Pen in a microwave, hot water or direct sunlight.

Let your Dupixent pre-filled pen warm up to room temperature on a flat surface for at least 45 minutes.

B. Choose and prepare your injection site

B1. Wash your hands well with soap and water

Wash hands with soap and water.

B2. Choose an injection site

  • Thigh
  • Stomach except for the 2 inches (5 cm) around your belly button (navel).
  • A caregiver can also inject in the outer area of the upper arm.
  • Choose a different site for each injection.
  • Do not inject into skin that is tender, damaged, has bruises or scars, or into areas with visible veins.
  • Do not inject through clothes.

You can self-inject your Dupixent pre-filled pen in you thighs or your stomach except for the 2 inches around your belly button. A caregiver can also inject Dupixent into their site and also the upper area or your outer arm.

B3. Prepare the injection site

  • 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.

Clean the injection site with an alcohol wipe and let the skin dry before injecting.

C. Give the injection

C1. Remove Green Cap

  • Remove the Green Cap by pulling it straight off, as shown. Do not twist the Green Cap off.
  • Do not remove the Green Cap until you are ready to inject.
  • Do not press or touch the Yellow Needle Cover with your fingers. The Needle is inside.
  • Do not put the Green Cap back on the Dupixent Pre-filled Pen after you have removed it.

Pull the green cap straight off your Dupixent pre-filled pen to reveal needle inside.

C2. Place

  • Hold the Dupixent Pre-filled Pen as shown so that you can see the Window. Place the Yellow Needle Cover on your skin.
  • Place the Yellow Needle Cover on your skin at approximately a 90-degree angle.

Hold the Dupixent pre-filled pen so that you can see the window on the pen. Place the yellow needle cover on your skin and hold the pen at a 90-degree angle.

C3. Press down ➜ Watch Window turn fully yellow ➜ Then count to 5

Press down on the pen, watch the window turn fully yellow and then count to 5 while holding the pen in place.

Press and hold the Dupixent Pre-filled Pen firmly against your skin until you cannot see the Yellow Needle Cover.

  • There will be a “click” when the injection starts, and
  • The Window will start to turn yellow.
  • Keep pressing the Dupixent Pre-filled Pen against your skin.
 Keep pressing the Dupixent Pre-filled Pen against your skin and watch the window:

  • The Window will turn completely yellow, and
  • You will hear a 2nd “click”.
  • Keep pressing the Dupixent Pre-filled Pen against your skin.
 Keep pressing the Dupixent Pre-filled Pen against your skin and count to 5 to make sure you get your full dose.

C4. Remove

  • After you have completed your injection pull straight up to remove Dupixent Pre-filled Pen from the skin. The Yellow Needle Cover will cover the needle.
  • If you see any blood at the site, lightly dab a cotton ball or gauze pad.
  • Do not rub your skin after the injection.

If the Window does not turn completely Yellow, remove the pen and call your healthcare provider.

  • Do not give yourself a second dose without speaking to your healthcare provider.

Pull the pen straight up to remove after you have finished your injection.

D. Dispose of used Dupixent Pre-filled Pen

How to Dispose of (throw away) Dupixent Pre-filled Pen

Put your used Dupixent Pre-filled Pens, and Green Caps in a FDA-cleared sharps disposal container right away after use.

Do not dispose of (throw away) Dupixent Pre-filled Pens and Green 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 tightfitting, 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 Dupixent Pre-filled Pens.

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 green cap back on the pen before disposing of it in a sharps disposal container.

Keep your sharps disposal container out of the reach of children.

Label

PRINCIPAL DISPLAY PANEL – 300 MG/2 ML SYRINGE CARTON – 5914

 

  • NDC 0024-5914-01
  • Rx Only
  • DUPIXENT®
    (dupilumab)
    Injection
  • 300 mg/2 mL (150 mg/mL)
  • For Subcutaneous Use Only.
  • 300 mg/2 mL
  • 2
    Single-dose
    Pre-filled Syringes
    with Needle Shield
  • Keep out of reach of children. Do not use after
    expiration. Do not use if seal is broken or damaged.
  • Store refrigerated at 36° to 46°F (2° to 8°C) in the original carton.
    Dosage and Administration: See package insert for dosage information and directions for use.
  • SANOFI GENZYME
  • REGENERON
PRINCIPAL DISPLAY PANEL - 300 mg/2 mL Syringe Carton - 5914

PRINCIPAL DISPLAY PANEL – 200 MG/1.14 ML SYRINGE CARTON

 

  • NDC 0024-5918-01
  • Rx Only
  • DUPIXENT®
    (dupilumab)
    Injection
  • 200 mg/1.14 mL (175 mg/mL)
  • For Subcutaneous Use Only.
  • 200 mg/1.14 mL
  • 2
    Single-dose
    Pre-filled Syringes
    with Needle Shield
  • Keep out of reach of children. Do not use after
    expiration. Do not use if seal is broken or damaged.
  • Store refrigerated at 36° to 46°F (2° to 8°C) in the original carton.
    Dosage and Administration: See package insert for dosage information and directions for use.
  • SANOFI GENZYME
  • REGENERON
PRINCIPAL DISPLAY PANEL - 200 mg/1.14 mL Syringe Carton

SRC: NLM .

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