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Dupixent

Generic name: dupilumab

What is Dupixent?

Dupixent is a prescription medicine used:

  • to treat people aged 12 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 to treat chronic rhinosinusitis with nasal polyposis in adults whose disease is not controlled.
  • 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.
  • Dupixent is not used to treat sudden breathing problems.
  • It is not known if Dupixent is safe and effective in children with atopic dermatitis or 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.

What is the most important information I should know about Dupixent?

Read all of the instructions carefully before using the Dupixent syringe.

Ask your healthcare provider how often you will need to inject the medicine.

Throw away (dispose of) the used Dupixent Single-Dose Pre-filled Syringe right away after use.

Do not re-use a Dupixent Single-Dose Pre-filled Syringe.

Who should not take Dupixent?

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

What should I tell my healthcare provider before taking 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 taking oral, topical, or inhaled corticosteroid medicines. Do not stop taking your corticosteroid medicines unless instructed by your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine to come back.
  • 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 Registry. There is a pregnancy registry for women who take Dupixent during pregnancy. The purpose of this registry is to collect information about your health and your baby's health. You can talk to your healthcare provider or contact 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/Dupixent/ to enroll in this registry or get more information.
  • 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. If you have asthma and are taking asthma medicines, do not change or stop your asthma medicine without talking to your healthcare provider.

How should I take 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.
  • Use Dupixent exactly as prescribed by your healthcare provider.
  • Dupixent comes as a single-dose pre-filled syringe with needle shield.
  • 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.
  • If you miss a dose of Dupixent, give the injection within 7 days from the missed dose, then continue with the original schedule. If the missed dose is not given within 7 days, wait until the next scheduled dose to give 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 leaflet. 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.

Instructions for use

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.

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.

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.

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.

Source: National Library of Medicine. Last updated June 26, 2019.