WARNINGS
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
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, and BP.
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 12 years of age, or who weigh less than 66 pounds (30 kg).
• BP under 18 years of age. BP is most often seen in adults.
USES
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 chronic spontaneous urticaria (CSU) in adults and children 12 years of age and older, who continue to have hives that are not controlled with H1 antihistamine treatment.
to treat adults with bullous pemphigoid (BP).
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, and BP.
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 12 years of age, or who weigh less than 66 pounds (30 kg).
BP under 18 years of age. BP is most often seen in adults.
HOW TO USE
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.
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 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.
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.
OVERDOSE
There is no specific treatment for DUPIXENT overdose. In the event of overdosage, contact Poison Control (1-800-222-1222) for the latest recommendations and monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.
MISSED DOSE
If a weekly dose is missed, administer the dose as soon as possible, and start a new weekly schedule from the date of the last administered dose.
If an every 2 week dose is missed, administer the injection within 7 days from the missed dose and then resume the patient’s original schedule. If the missed dose is not administered within 7 days, administer the dose, starting a new schedule based on this date.
If an every 4 week dose is missed, administer the injection within 7 days from the missed dose and then resume the patient’s original schedule. If the missed dose is not administered within 7 days, administer the dose, starting a new schedule based on this date.
STORAGE
Store DUPIXENT in the refrigerator between 36-degrees F to 46-degrees F (2-degrees C to 8-degrees C).
Store DUPIXENT in the original carton to protect from light.
DUPIXENT can be stored at room temperature up to 77-degrees F (25-degrees 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
NOTES
Medication Guide: revision date 06/2025
Prescribing Information: revision date 06/2025
An effect of dupilumab on the PK of co-administered medications is not expected. Based on the population analysis, commonly co-administered medications had no effect on DUPIXENT pharmacokinetics in subjects with moderate-to-severe asthma.
Cytochrome P450 Substrates
The effects of dupilumab on the pharmacokinetics of midazolam (metabolized by CYP3A4), warfarin (metabolized by CYP2C9), omeprazole (metabolized by CYP2C19), metoprolol (metabolized by CYP2D6), and caffeine (metabolized by CYP1A2) were evaluated in a study with 12-13 evaluable subjects with AD (a SC loading dose of 600 mg followed by 300 mg SC weekly for six weeks). No clinically significant changes in AUC were observed. The largest effect was observed for metoprolol (CYP2D6) with an increase in AUC of 29%.
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. 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 AD, CRSwNP, EoE, PN, COPD, CSU, or BP 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.
