Dupixent

Dupixent (dupilumab) is used to treat a range of moderate-to-severe inflammatory conditions, including atopic dermatitis (eczema), asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, COPD, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis. Depending on the condition and the patient's age or weight, Dupixent is injected under the skin every week, every 2 weeks, or every 4 weeks using a prefilled syringe or pen.

Dupixent first gained FDA approval on March 28, 2017, for atopic dermatitis, and is now approved across nine separate indications. It is manufactured by Regeneron Pharmaceuticals and marketed by sanofi-aventis U.S. LLC and Regeneron Pharmaceuticals.

Dupixent is FDA-approved for:

• Moderate-to-severe atopic dermatitis (AD, eczema) in adults and children 6 months and older whose AD is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Can be used with or without topical corticosteroids.
• Moderate-to-severe asthma as add-on maintenance therapy in adults and children aged 6 years and older with asthma characterized by an eosinophilic phenotype or with oral-corticosteroid-dependent asthma. Dupixent is not indicated for the relief of acute bronchospasm or status asthmaticus.
• Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years and older with inadequately controlled CRSwNP, as add-on maintenance treatment.
• Eosinophilic esophagitis (EoE) in adults and children aged 1 year and older weighing at least 15 kg (33 lbs).
• Prurigo nodularis (PN) in adults.
• Chronic obstructive pulmonary disease (COPD) in adults with inadequately controlled COPD and an eosinophilic phenotype, as add-on maintenance treatment. Not indicated for the relief of acute bronchospasm.
• Chronic spontaneous urticaria (CSU) in adults and children 2 years and older who remain symptomatic despite H1 antihistamine treatment. Dupixent is not indicated for other forms of urticaria.
• Bullous pemphigoid (BP) in adults.
• Allergic fungal rhinosinusitis (AFRS) in adults and children 6 years and older who have a history of sino-nasal surgery.

Dupixent has been studied in placebo-controlled trials across all nine approved conditions. The table below summarizes the main results from the pivotal trial or trials supporting each indication.

See the detailed Instructions for Use that comes with Dupixent for information on how to prepare and inject Dupixent, and how to store and throw away used prefilled syringes and 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 prefilled syringe with a needle shield or as a single-dose prefilled pen. The prefilled pen is only for use in adults and children 2 years of age and older. The prefilled 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, 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, Dupixent should be given under the supervision of an adult.
• In children 6 months to less than 12 years of age, Dupixent should be given by a caregiver.

Where to inject Dupixent

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

• Inject into the thigh or the stomach area (abdomen), but not within 2 inches (5 cm) of the navel.
• The upper arm can also be used, but only if a caregiver gives the injection.
• Rotate the injection site with each dose.
• Do not inject into skin that is tender, damaged, bruised, or scarred.
• If your starting dose is 600 mg, it is given as two 300 mg injections at two different injection sites. If your starting dose is 400 mg, it is given as two 200 mg injections at two different injection sites.

Preparing your injection

• Take Dupixent out of the refrigerator and let it reach room temperature before injecting, with the needle cap left on. Allow 45 minutes for the 300 mg/2 mL prefilled syringe or pen, and 30 minutes for the 200 mg/1.14 mL prefilled syringe or pen.
• Look at the liquid before you inject. Dupixent should be clear to slightly opalescent and colorless to pale yellow. Do not use it if it contains visible particles or if it is discolored or cloudy.
• Dupixent does not contain a preservative. Throw away any unused medicine left in the syringe or pen.

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

Do not use Dupixent if you are allergic to dupilumab or to any of the other ingredients in the injection.

It is not known if Dupixent is safe and effective in:

• Atopic dermatitis in children under 6 months
• Asthma in children under 6 years
• CRSwNP in children under 12 years
• EoE in children under 1 year, or who weigh less than 33 pounds (15 kg)
• Prurigo nodularis in people under 18 years
• COPD in people under 18 years
• CSU in children under 2 years, or who weigh less than 11 pounds (5 kg)
• Bullous pemphigoid in people under 18 years
• AFRS in children under 6 years.

Before receiving this medicine, tell your healthcare provider about all your medical conditions, including if you:

• Have eye problems, including significant dry eye disease, past eyelid abnormalities or eyelid surgery, or past tear duct surgery
• Have a parasitic (helminth) infection
• Have asthma, if you are being treated for another condition
• Are taking any oral, topical, or inhaled corticosteroid
• Are scheduled to receive any vaccinations. You should not receive a live vaccine before or during treatment with Dupixent
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

Pregnancy

Available data from case reports and case series of Dupixent use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placenta, so Dupixent may be passed from mother to the developing baby, particularly in the third trimester.

There is a pregnancy exposure registry for women who use Dupixent during pregnancy. Your healthcare provider can enroll you, or you can enroll yourself by calling 1-877-311-8972 or going to https://mothertobaby.org/ongoing-study/dupixent/.

If you have asthma, keep in mind that poorly or moderately controlled asthma in pregnancy carries its own risks, including preeclampsia, prematurity, low birth weight, and a baby that is small for gestational age. Asthma control should be closely monitored during pregnancy.

Breastfeeding

There are no data on the presence of dupilumab in human milk, on effects on the breastfed infant, or on milk production. Maternal IgG is known to be present in human milk. Talk to your healthcare provider about the best way to feed your baby if you are taking Dupixent.

Common side effects

The most common side effects of Dupixent are:

• Injection site reactions
• Eye problems, including conjunctivitis, eyelid inflammation (blepharitis), keratitis, itchy eyes, dry eye, and blurred vision
• Upper respiratory tract infections
• Cold sores in your mouth or on your lips (oral herpes) and other herpes virus infections
• Common cold symptoms (nasopharyngitis)
• High count of a certain white blood cell (eosinophilia)
• Viral infections
• Pain in the throat (oropharyngeal pain)
• Joint pain (arthralgia)
• Back pain
• Headache
• Inflammation inside the nose (rhinitis)
• Dizziness
• Muscle pain
• Diarrhea
• Stomach problems (gastritis)
• Trouble sleeping (insomnia)
• Toothache
• Urinary tract infections
• Parasitic (helminth) infections.

How often do side effects happen?

Side effect rates differ by the condition being treated. The table below shows the most frequently reported side effects from the placebo-controlled trials for each condition.

Side effects reported in people with allergic fungal rhinosinusitis were similar to those reported in people with chronic rhinosinusitis with nasal polyps.

Serious side effects and warnings

Dupixent can cause the following serious side effects.

Allergic reactions

Dupixent can cause allergic (hypersensitivity) reactions, including anaphylaxis, acute generalized exanthematous pustulosis (AGEP), serum sickness or serum-sickness-like reactions, angioedema, generalized hives, rash, erythema nodosum, and erythema multiforme. 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 a rash that looks like a bullseye, painful red or blue bumps under the skin, or red pus-filled spots on the skin.

Eye problems

Conjunctivitis, keratitis, and blepharitis have been reported with Dupixent. 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, and may consider stopping Dupixent.

After approval, some people have reported varying degrees of temporary or ongoing visual impairment, including blindness, associated with conjunctivitis, keratitis, or blepharitis. In some cases, this led to Dupixent being stopped or to surgery. Dupixent should be used with caution in people with significant dry eye disease, a history of significant eyelid abnormalities or eyelid surgery, or a history of tear duct (nasolacrimal) surgery.

Eosinophilic conditions

People being treated for asthma may develop clinical features of eosinophilic pneumonia or eosinophilic granulomatosis with polyangiitis (EGPA), a form of blood vessel inflammation (vasculitis). These events may be associated with reducing oral steroid therapy. Cases of EGPA have also been reported in adults with co-morbid asthma treated for nasal polyps. Tell your healthcare provider right away if you get:

• A rash
• Worsening shortness of breath
• Persistent fever
• Chest pain
• Brown or dark colored urine
• A feeling of pins and needles or numbness in your arms or legs.

Dupixent does not treat sudden asthma or COPD symptoms

Dupixent should not be used to treat sudden symptoms or sudden flare-ups of asthma or COPD, and is not a treatment for acute bronchospasm or status asthmaticus. Seek medical advice if your asthma or COPD stays uncontrolled or gets worse after you start Dupixent.

Do not stop your steroid medicine suddenly

Do not stop taking systemic, topical, or inhaled corticosteroids suddenly when you start Dupixent. If your steroid dose is to be reduced, this should be done gradually and under the direct supervision of your healthcare provider. Reducing a steroid dose can cause withdrawal symptoms or can unmask conditions that the steroid was previously suppressing.

If you also have asthma

If you are being treated with Dupixent for another condition and you also have asthma, do not adjust or stop your asthma treatments without talking to your healthcare provider first.

Psoriasis

New-onset psoriasis has been reported in people with atopic dermatitis and asthma who receive Dupixent, including in people with no family history of psoriasis. Onset has ranged from weeks to months after the first dose. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist or may consider stopping Dupixent.

Joint aches and pain

Joint aches and pain (arthralgia) can happen in people who use Dupixent. Some people have had trouble walking or moving because of their joint symptoms, and in some cases needed to be hospitalized. New-onset psoriatic arthritis requiring systemic treatment has also been reported. Onset has ranged from days to months after the first dose. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop Dupixent if you develop joint symptoms.

Parasitic (helminth) infections

It is not known whether Dupixent affects the immune response to parasitic worm infections. Pre-existing helminth infections should be treated before you start Dupixent. If you become infected while on Dupixent and do not respond to anti-helminth treatment, Dupixent should be stopped until the infection clears.

Vaccinations

Consider completing all age-appropriate vaccinations before starting Dupixent. Avoid live vaccines during treatment with Dupixent. It is not known whether a live vaccine given during Dupixent treatment will be safe or effective. Tell your healthcare provider you are taking Dupixent before any vaccination.

Side effects reported after approval

The following side effects have been reported since Dupixent came onto the market. Because these are reported voluntarily, it is not always possible to estimate how often they happen or to confirm they were caused by Dupixent.

• Immune system: angioedema (swelling under the skin)
• Muscles and joints: psoriatic arthritis
• Skin: facial skin reactions, including redness (erythema), rash, scaling, swelling, small raised bumps, itching, burning, and pain; new-onset psoriasis; vasculitis
• Eyes: ectropion (outward-turning eyelid), scarring of the eye surface, scarring ectropion, narrowing or blockage of the tear duct, symblepharon (adhesion of the eyelid to the eyeball), and temporary or ongoing vision loss, including visual impairment and blindness associated with conjunctivitis, keratitis, or blepharitis

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 the FDA at 1-800-FDA-1088.

Dupixent (dupilumab) is a human monoclonal antibody that blocks the signaling of two inflammatory proteins, interleukin-4 (IL-4) and interleukin-13 (IL-13). It does this by binding to the IL-4 receptor alpha (IL-4R alpha) subunit, a component shared by both the IL-4 and IL-13 receptor complexes. Dupixent blocks IL-4 signaling through 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 part of what causes eczema, asthma, nasal polyps, eosinophilic esophagitis, prurigo nodularis, COPD, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis. By blocking IL-4R alpha, Dupixent interrupts the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. The exact mechanism of dupilumab has not been definitively established.

Dupixent belongs to the drug class called interleukin-4 receptor alpha antagonists. It may also be called an interleukin inhibitor.

Dose of Dupixent for atopic dermatitis (AD)

Adults: 600 mg subcutaneously for the first dose, then 300 mg subcutaneously every 2 weeks.

Children 6 months to 5 years. No initial loading dose is recommended.

Children 6 through 17 years

Dupixent can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, skin folds, and genital areas.

Dose of Dupixent for asthma

Adults and children 12 years and older

Adults and children 12 years and older with oral-corticosteroid-dependent asthma, or with co-morbid moderate-to-severe AD, CRSwNP, or AFRS: 600 mg subcutaneously for the first dose, then 300 mg subcutaneously every 2 weeks. This regimen applies to children 12 to 17 years weighing 60 kg or more, and to adults with AFRS.

Children 6 to 11 years. No initial loading dose is recommended.

Children 6 to 11 years who have asthma and co-morbid moderate-to-severe atopic dermatitis should follow the atopic dermatitis dosing for children 6 through 17 years instead, which includes an initial loading dose.

Dose of Dupixent for chronic rhinosinusitis with nasal polyps (CRSwNP)

Adults and children 12 years and older: 300 mg subcutaneously every 2 weeks.

Dose of Dupixent for eosinophilic esophagitis (EoE)

Adults and children 1 year and older weighing at least 15 kg

Dose of Dupixent for prurigo nodularis (PN)

Adults: 600 mg subcutaneously for the first dose, then 300 mg subcutaneously every 2 weeks.

Dose of Dupixent for chronic obstructive pulmonary disease (COPD)

Adults: 300 mg subcutaneously every 2 weeks.

Dose of Dupixent for chronic spontaneous urticaria (CSU)

Adults: 600 mg subcutaneously for the first dose, then 300 mg subcutaneously every 2 weeks.

Children 6 to 17 years

Children 2 to 5 years. No initial loading dose is recommended.

Dose of Dupixent for bullous pemphigoid (BP)

Adults: 600 mg subcutaneously for the first dose, then 300 mg subcutaneously every 2 weeks. Dupixent is used together with a tapering course of oral corticosteroids. Once disease control is achieved, corticosteroids are gradually tapered, after which Dupixent is continued on its own. If the condition relapses, corticosteroids may be added back if medically advisable.

Dose of Dupixent for allergic fungal rhinosinusitis (AFRS)

Adults: 300 mg subcutaneously every 2 weeks.

Children 6 to 17 years

Weekly schedule: Inject the missed dose as soon as possible, then start a new weekly schedule from the date of that dose.

Every 2 weeks:

• If you are within 7 days of the missed dose, inject it and stay on your original schedule.
• If more than 7 days have passed, inject the dose and start a new schedule from that date.

Every 4 weeks:

• If you are within 7 days of the missed dose, inject it and stay on your original schedule.
• If more than 7 days have passed, inject the dose and start a new schedule from that date.

There is no specific treatment for a Dupixent overdose. If you inject too much Dupixent, call your healthcare provider or the Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away.

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

Dupixent is not expected to affect how your other medicines are processed by the body. In a study of 12 to 13 people with atopic dermatitis, dupilumab was tested alongside midazolam (broken down by CYP3A4), warfarin (CYP2C9), omeprazole (CYP2C19), metoprolol (CYP2D6), and caffeine (CYP1A2). No clinically significant changes in drug exposure were seen. The largest effect was with metoprolol, where exposure (AUC) increased by 29%.

Commonly co-administered medicines have not been found to affect Dupixent levels in people with moderate-to-severe asthma.

Avoid live vaccines while you are receiving Dupixent.

See the Dupixent Prescribing Information for more information about interactions.

The cost of Dupixent varies significantly based on your insurance coverage, prescription drug plan type, whether it is on your plan's preferred medication list, and your deductible. Use the Dupixent Cost and Coverage Tool for personalized estimates.

Dupixent MyWay patient support program

Sanofi and Regeneron Pharmaceuticals offer support for patients on Dupixent, including:

• Copay cards for eligible patients
• Medication access assistance
• Injection training
• Prescription delivery coordination
• Educational resources

For detailed information about copay cards and patient assistance programs, visit the Dupixent website or ask your healthcare provider.

For detailed information, see Dupixent Prices, Coupons, Copay Cards and Patient Assistance.

• Store Dupixent in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Store in the original carton to protect it from light.
• If necessary, Dupixent may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. Do not store above 77°F (25°C).
• After it is taken out of the refrigerator, Dupixent must be used within 14 days or thrown away.
• Do not expose Dupixent to heat or direct sunlight.
• Do not freeze. Do not shake.
• Dupixent is sterile and preservative-free. Throw away any unused portion.

Keep out of the reach of children.

Active ingredient: dupilumab.

Inactive ingredients: L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection. The pH is 5.9.

Dupixent comes as a single-dose prefilled syringe with a needle shield, or as a single-dose prefilled pen (autoinjector). Both are available in the following strengths:

• 300 mg/2 mL (150 mg/mL)
• 200 mg/1.14 mL (175 mg/mL)

Dupixent is supplied in cartons containing 2 prefilled syringes with needle shields, or 2 prefilled pens.

The needle cap is not made with natural rubber latex.

What does Dupixent SOPN mean?

SOPN stands for Solution Pen-Injector, indicating the Dupixent prefilled pen formulation.

What does Dupixent SOSY mean?

SOSY stands for Solution Prefilled Syringe, indicating the Dupixent prefilled syringe formulation.

Dupixent (dupilumab) is manufactured by Regeneron Pharmaceuticals, Inc., Tarrytown, NY (U.S. License No. 1760). It is marketed by sanofi-aventis U.S. LLC, Morristown, NJ, and Regeneron Pharmaceuticals, Inc.