Patient information: uses, side effects, how to take - Dupixent

What is DUPIXENT?

DUPIXENT is a prescription medicine used:

to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) 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 adults and children 6 years of age 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 polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled.
to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15 kg).
to treat adults with prurigo nodularis (PN).
with other medicines for the maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to your COPD). DUPIXENT is used to reduce the number of flare-ups (the worsening of your COPD symptoms for several days) and can improve your breathing.
to treat adults and children 2 years of age and older with chronic spontaneous urticaria (CSU), who continue to have hives that are not controlled with H1 antihistamine treatment.
to treat adults with bullous pemphigoid (BP).
to treat adults and children 6 years of age and older with allergic fungal rhinosinusitis (AFRS) who have had surgery on their nose or sinuses in the past.

DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine or to treat any other forms of hives (urticaria).

DUPIXENT works by blocking two proteins that contribute to a type of inflammation that plays a major role in AD, asthma, CRSwNP, EoE, PN, COPD, CSU, BP, and AFRS.

It is not known if DUPIXENT is safe and effective in children with:

AD under 6 months of age.
Asthma under 6 years of age.
CRSwNP under 12 years of age.
EoE under 1 year of age, or who weigh less than 33 pounds (15 kg).

PN under 18 years of age.
COPD under 18 years of age. COPD is most often seen in adults.
CSU under 2 years of age, or who weigh less than 11 pounds (5 kg).
BP under 18 years of age. BP is most often seen in adults.
AFRS under 6 years of age.

Do not use DUPIXENT if you are allergic to dupilumab or to any of the ingredients in DUPIXENT. See the end of this Patient Information leaflet for a complete list of ingredients in 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" right before and during treatment 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 use DUPIXENT during pregnancy. The purpose of this registry is to collect information about the health of you and your baby.
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 AD, CRSwNP, EoE, PN, COPD, CSU, BP, or AFRS, and also have asthma

Do not change or stop your other medicines, including corticosteroid medicine or other asthma medicine, without talking to your healthcare provider. This may cause other symptoms that were controlled by those medicines 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.
- The DUPIXENT pre-filled pen is only for use in adults and children 2 years of age and older.
- The DUPIXENT pre-filled syringe is for use in adults and children 6 months of age and older.
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 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.
If your dose schedule is every week and you miss a dose of DUPIXENT: Give the DUPIXENT injection as soon as possible and start a new every week dose schedule from the time you remember to take your DUPIXENT injection.
If your dose schedule is every 2 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 2-week dose schedule from the time you remember to take 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 too much DUPIXENT, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room 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. DUPIXENT can cause allergic reactions, including skin reactions, that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms:

breathing problems or wheezing
fast pulse
fever
general ill feeling
swollen lymph nodes
joint pain

swelling of the face, lips, mouth, tongue, or throat
hives
itching
nausea or vomiting
cramps in your stomach-area

fainting, dizziness, feeling lightheaded
skin rash, including rash that looks like a bullseye, painful red or blue bumps under the skin, or red pus-filled spots on the skin

Eye problems. Tell your healthcare provider right away if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an eye exam if needed.
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. Tell your healthcare provider right away if you get:

rash
worsening shortness of breath
persistent fever

chest pain
brown or dark colored urine
a feeling of pins and needles or numbness of your arms or legs

Psoriasis. This can happen in people with atopic dermatitis and asthma who receive DUPIXENT. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination if needed.
Joint aches and pain. Joint aches and pain can happen in people who use DUPIXENT. Some people have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms.

The most common side effects of DUPIXENT include:

injection site reactions
upper respiratory tract infections
eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, dry eye, and blurred vision
herpes virus infections
common cold symptoms (nasopharyngitis)
cold sores in your mouth or on your lips
high count of a certain white blood cell (eosinophilia)
viral infection
back pain
inflammation inside the nose (rhinitis)

dizziness
muscle pain
diarrhea
pain in the throat (oropharyngeal pain)
stomach problems (gastritis)
joint pain (arthralgia)
trouble sleeping (insomnia)
toothache
parasitic (helminth) infections
headache
urinary tract infection

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.

How should I store DUPIXENT?

Store DUPIXENT in the refrigerator between 36°F to 46°F (2°C to 8°C).
Store DUPIXENT in the original carton to protect from light.
DUPIXENT can be stored at room temperature up to 77°F (25°C) up to 14 days. Throw away (dispose of) any DUPIXENT that has been left at room temperature for longer than 14 days.
Do not heat or put DUPIXENT into direct sunlight.
Do not freeze. Do not shake.

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

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.

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.

Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591 U.S. License No. 1760

Marketed by: sanofi-aventis U.S. LLC (Morristown, NJ 07960) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591)

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

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.

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.

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 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 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 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 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 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.

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 (Morristown, NJ 07960) 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: May 2025