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Dupixent

Pronunciation: DU-pix-ent
Generic name: dupilumab
Dosage form: injection for subcutaneous use
Drug class: Interleukin inhibitors

What is Dupixent?

Dupixent is used to treat eczema, eosinophilic or oral-corticosteroid-dependent asthma, chronic rhinosinusitis with nasal polyps, COPD with an eosinophilic phenotype, eosinophilic esophagitis (EOE), or prurigo nodularis. It is given as a subcutaneous (under the skin) injection every 1 to 4 weeks. People can be taught how to self-administer it.

Dupixent (dupilumab) gained FDA approval on March 28, 2017 for eczema. Approvals for other medical conditions followed, based on the results of clinical trials. There is no generic or biosimilar.

How does Dupixent work?

Dupixent's mechanism of action involves targeting and blocking two key inflammatory proteins in the body, interleukin-4 (IL-4) and interleukin-13 (IL-13).

These control inflammatory signalling pathways and substances such as proinflammatory cytokines, nitric oxide, and IgE (immunoglobulin E), all of lead to inflammation and conditions such as eczema, asthma, COPD, rhinosinusitis, and EOE.

Dupixent is not an immunosuppressant. It calms overreactive immune systems, rather than fully suppressing them.

Dupixent belongs to the drug class called interleukin inhibitors.

Approvals and indications

Dupixent is FDA-approved to treat the following conditions that have inflammation as a symptom:

Eczema. Dupixent is used for eczema (atopic dermatitis) that is moderate to severe in adults and children 6 months and older whose condition is not well controlled with prescription treatments used on the skin (topical) or who cannot use topical therapies. Can be used with or without topical corticosteroids.

Asthma. In adults and children aged 6 and older, Dupixent treats moderate-to-severe eosinophilic or oral-corticosteroid-dependent asthma in addition to other asthma maintenance treatments. Will NOT treat an acute asthma attack or status asthmatics (an extreme form of acute asthma).

Chronic rhinosinusitis with nasal polyps. Dupixent is used for inadequately controlled chronic rhinosinusitis (a long-standing inflammation of the sinuses) with nasal polyps, as an add-on maintenance treatment in adults and children aged 12 years and older.

COPD. In adults, Dupixent can be used for inadequately controlled COPD with an eosinophilic phenotype as an add-on maintenance treatment.

EOE. Dupixent is also used for eosinophilic esophagitis (EOE) in adults and children 1 year of age and older, who weigh at least 33 pounds (15 kg).

Prurigo nodularis in adults.

Dupixent cost

The cost of Dupixent varies based on your insurance coverage, including type of prescription drug insurance, preferred medication status, and deductible status.

Dupixent MyWay provides comprehensive support including:

Financial assistance through copay cards for eligible patients

Help to access the medication

Injection training and support

Prescription delivery coordination

Educational resources.

Dupixent side effects

Common side effects of Dupixent

Injection site reactions (pain, swelling, burning, irritation)

Upper respiratory tract infections (stuffy nose, sneezing, sore throat)

Eye-related problems (inflammation, redness, swelling, itching, blurred vision)

Herpes virus infections and cold sores

Elevated white blood cell counts (eosinophilia)

Musculoskeletal issues (back pain, muscle/joint pain)

Respiratory symptoms (rhinitis, throat pain)

Digestive issues (diarrhea, gastritis)

General symptoms (dizziness, insomnia, headache)

Other infections (parasitic, urinary tract)

Facial rash or redness

Dupixent injections may hurt

Note on weight gain

While not listed in the official Dupixent Package Insert, some people have reported weight gain as an anecdotal side effect

Serious side effects and warnings

Dupixent can cause the following serious side effects.

Allergic reactions. Dupixent can serious hypersensitivity reactions such as anaphylaxis, serum sickness, angioedema, urticaria, rash, erythema nodosum, and erythema multiforme. Do not use Dupixent if you are allergic to dupilumab or any of the ingredients. Seek immediate medical attention for signs of severe allergic reactions including:

Breathing difficulties or wheezing

Rapid heartbeat

Fever

Lymph node swelling

Facial/throat swelling

Skin reactions (hives, itching, rash)

Gastrointestinal symptoms (nausea, vomiting, stomach cramps)

Fainting or dizziness

Joint pain.

Eye problems. Tell your healthcare provider if you have any new or worsening eye problems while taking Dupixent, including eye pain, vision changes (such as blurred vision), or conjunctivitis (red or sticky eyes). Your healthcare provider may send you to an ophthalmologist for an eye exam.

Dupixent may cause blood vessel inflammation. Tell your healthcare provider right away if you have:

An unexplained rash

Worsening breathing difficulties

Persistent fever

Chest pain

Pins and needles sensation or numbness in your limbs.

Joint aches and pain. Severe joint pain affecting mobility has been reported in some people who have used Dupixent. Tell your healthcare provider about any new or worsening joint symptoms.

May increase the risk of developing eosinophilic conditions. These are conditions associated with overproduction of eosinophils, causing chronic inflammation and tissue damage. Tell your doctor if you develop a red or purple rash, shortness of breath, tingling or nerve pain in your hands or feet.

Important safety information

Parasitic Infections

Must treat existing infections before starting Dupixent

Discontinue if new infection doesn't respond to treatment

Corticosteroid Usage

Continue as directed by your healthcare provider

Never stop suddenly without medical guidance

Vaccination Guidelines

Avoid live vaccines during treatment

May reduce vaccine effectiveness

Asthma/COPD Management

Not for sudden breathing problems

Does not replace rescue inhalers

Age Restrictions

Dupixent's safety and effectiveness are not established for:

AD/eczema: under 6 months

Asthma: under 6 years

Chronic rhinosinusitis with nasal polyposis: under 12 years

EOE: under 1 year or below 33 pounds (15 kg)

COPD with eosinophilic phenotype: under 18 years

Prurigo nodularis: under 18 years

Tell your healthcare provider if you have any side effect that bothers you or 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 the FDA at 1-800-FDA-1088.

Before taking

Do not receive if you are allergic to dupilumab, Dupixent, or any inactive ingredients in the injection.

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

have eye problems

have a parasitic (helminth) infection, such as pinworms, roundworms or tapeworms

are scheduled to receive any vaccinations. You should not receive a “live vaccine” right before and during treatment with Dupixent

are taking oral, topical, or inhaled corticosteroid medicines

have asthma and use an asthma medicine or have other medical conditions such as AD, chronic rhinosinusitis, EOE, prurigo nodularis, or chronic obstructive pulmonary disease, and also have asthma

are pregnant or plan to become pregnant

are breastfeeding or plan to breastfeed.

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

Pregnancy

It is not known whether Dupixent will harm your unborn baby. Ask your healthcare provider about the risks vs benefits of using Dupixent during pregnancy.

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 the MotherToBaby Dupixent study page.

Breastfeeding

It is not known whether Dupixent passes into your breast milk.

How do I use Dupixent?

Use Dupixent exactly as prescribed by your doctor. See the detailed “Instructions for Use” that comes with the Dupixent Package Insert for the Dupixent Prefilled Syringe or Dupixent Prefilled pen including how to properly store and throw away (dispose of) used Dupixent pre-filled syringes and pre-filled pens.

Your healthcare provider will tell you how much Dupixent to inject and how often to inject it. Dupixent is only available from a speciality pharmacy that will work with you to schedule your shipments.

Dupixent is usually administered once every 1 to 4 weeks depending on the condition.

Dupixent is given as an injection under the skin (subcutaneous injection).

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.

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 it 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.

Your healthcare provider may prescribe other medicines to use with Dupixent. Use the other prescribed medicines exactly as your healthcare provider tells you to.

How to administer Dupixent

Dupixent is injected under the skin, usually once every 1 to 4 weeks. Your first dose may be given in 2 injections.

Take a syringe or pen out of the refrigerator and let it reach room temperature for 30 to 45 minutes before injecting your dose. Leave the needle cap on until you are ready to inject your dose.

Do not shake the prefilled syringe or injection pen. Prepare your injection only when you are ready to give it.

Do not use it if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

The Dupixent prefilled pen or syringe may be injected under the skin of your upper thigh or stomach area (except for the 2 inches [5 cm]) around your belly button (navel). Caregivers may also inject it 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.

Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.

Dupixent dosing

The dosage of Dupixent depends on the condition being treated and the person's age.

Dupixent for eczema

Dupixent dosing for eczema for adults: An initial dose of Dupixent 600 mg (two 300 mg injections), followed by 300 mg given every other week.

Dupixent dosing for eczema child (6 months to 5 years):

Body weight	Initial and subsequent Dupixent dosage
5 to less than 15 kg	200 mg (one 200 mg injection) every 4 weeks (Q4W)
15 to less than 30 kg	300 mg (one 300 mg injection) every 4 weeks (Q4W)

Dupixent dosing for eczema child (6 years to 17 years):

Body weight	Initial Dupixent loading dose	Subsequent Dupixent dosage
15 to less than 30 kg	600 mg (two 300 mg injections)	300 mg every 4 weeks (Q4W)
30 to less than 60 kg	400 mg (two 200 mg injections)	200 mg every 2 weeks (Q2W)
60 kg or more	600 mg (two 300 mg injections)	300 mg every 2 weeks (Q2W)

Dupixent for Asthma

Dupixent dosing for asthma for adults and children aged 12 and older:

Initial Dupixent loading dose	Subsequent Dupixent dosage
400 mg (two 200 mg injections)	200 mg every 2 weeks (Q2W)
Or
600 mg (two 300 mg injections)	300 mg every 2 weeks (Q2W)
Dupixent dosage for patients with oral corticosteroid-dependent asthma or with co-morbid moderate-to-severe atopic dermatitis or adults with comorbid chronic rhinosinusitis with nasal polyps
600 mg (two 300 mg injections)	300 mg every 2 weeks (Q2W)

Dupixent dosing for asthma for children aged 6 to 11 years:

Body weight	Initial Dupixent dose and subsequent dose
15 to less than 30 kg	300 mg every four weeks (Q4W)
30 kg or more	200 mg every other week (Q2W)

Dupixent for chronic rhinosinusitis with nasal polyps

The recommended Dupixent dosage for adults and children aged 12 and older for chronic rhinosinusitis with nasal polyps is Dupixent 300 mg given every other week (Q2W).

Dupixent for EoE (eosinophilic esophagitis)

Dupixent dosing for EOE for adults and children aged 1 year and older weighing at least 15kg:

Body weight	Recommended Dupixent dosage
15 to less than 30 kg	200 mg every other week (Q2W)
30 to less than 40 kg	300 mg every other week (Q2W)
40 kg or more	200 mg every week (QW)

Dupixent for prurigo nodularis

The recommended dosage for adults with prurigo nodularis is an initial dose of Dupixent 600 mg (two
300 mg injections), followed by Dupixent 300 mg given every other week (Q2W).

Dupixent for COPD (chronic obstructive pulmonary disease)

The recommended dosage for adults with COPD is Dupixent 300 mg given every other week (Q2W).

What happens if I miss a dose of Dupixent?

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 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.

What happens if I overdose?

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.

What should I avoid while using Dupixent?

Do not receive a "live" vaccine while using Dupixent. The vaccine may not work as well during this time and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect Dupixent?

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, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, or prurigo nodularis, 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.

Dupixent has not been reported to have a drug interaction with alcohol

Dupixent storage

Store Dupixent in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. You may store a Dupixent prefilled syringe or Dupixent injection pen at cool room temperature for up to 14 days. Do not store above 25°C (77°F).

Throw Dupixent injection away if not used within 14 days. Do not put it back into the refrigerator. Do not expose a Dupixent injection to heat or direct sunlight. Do NOT freeze. Do NOT shake.

Dupixent injection ingredients

Active ingredients: dupilumab.

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

Dupixent injection comes as a single-dose pre-filled syringe with a needle shield or as a pre-filled pen.

The pre-filled syringe is available as Dupixent 300mg/2mL, 200mg/1.14mL, and 100mg/0.67mL.

The pre-filled pen is available as Dupixent 300mg/2mL, and 200mg/1.14 mL.

What does Dupixent SOPN mean?

The abbreviation SOPN is often used with Dupixent 300 mg/2 mL as Dupixent 300 mg/2 mL SOPN. The SOPN stands for Solution Pen-Injector and means that this Dupixent injection is a prefilled pen.

What does Dupixent SOSY mean?

The abbreviation SOSY may be associated with Dupixent 300 mg/2 mL as Dupixent 300 mg/2 mL SOSY. The SOSY stands for Solution Prefilled Syringe, which means that this Dupixent injection is a prefilled syringe.

Who makes Dupixent?

Dupixent (dupilumab) is manufactured by Sanofi and Regeneron Pharmaceuticals through a collaboration agreement.

Key drugs from Sanofi include: Lantus (diabetes), Aubagio (multiple sclerosis), and various vaccines including Fluzone (flu).

Regeneron's major drugs include: Eylea (macular degeneration), Praluent (cholesterol), and REGEN-COV (COVID-19 antibody treatment).

Dupixent Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Dupixent.
Dupixent (dupilumab) - Regeneron Pharmaceuticals, Inc.

Formulation type	Strength
Autoinjector	200 mg/1.14 mL
Autoinjector	300 mg/2 mL
Pre-Filled Syringe	100 mg/0.67 mL Discontinued
Pre-Filled Syringe	200 mg/1.14 mL
Pre-Filled Syringe	300 mg/2 mL
Pre-Filled Syringe	300 mg/2 mL Discontinued

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