Dupilumab

Pronunciation: DU-pill-U-mab
Brand name: Dupixent
Dosage form: injection for subcutaneous use
Drug class: Interleukin inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Feb 8, 2024.

What is dupilumab?

Dupilumab (Dupixent) is a biologic that is given by subcutaneous (under the skin) injection that may be used to treat the following inflammatory conditions:

• Moderate to severe atopic dermatitis (eczema) in adults and children 6 months and older whose condition is not well controlled with topical prescription therapies or who cannot use topical therapies. Dupilumab can be used with or without topical corticosteroids
• Moderate-to-severe eosinophilic or oral-corticosteroid-dependent asthma in adults and children who are at least 6 years old as add-on maintenance treatment. It is used to treat acute bronchospasm or status asthmaticus
• Inadequately controlled chronic rhinosinusitis (a long-standing inflammation of the sinuses) that is associated with nasal polyps, as an add-on maintenance treatment in adults
• Eosinophilic esophagitis in adults and children 1 year of age and older, who weigh at least 33 pounds (15 kg)
• Prurigo nodularis in adults.

Dupilumab works by targeting and binding to a protein that is associated with inflammation called interleukin-4 (IL-4) receptor alpha subunit (IL-4Ra)], preventing IL-4 and IL-3 signaling. This inhibits the inflammatory response including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. Dupilumab is an interleukin-4 receptor alpha antagonist.

Dupilumab was first FDA-approved on March 28, 2017.

Warnings

Hypersensitivity reactions including anaphylaxis, serum sickness, angioedema, urticaria, rash, erythema nodosum, and erythema multiforme have been reported with Dupilumab. Do not use Dupilumab if you are allergic to dupilumab or any of the ingredients. Stop Dupilumab immediately and contact your healthcare provider if you develop any allergy symptoms.

May cause conjunctivitis and keratitis. Report new onset or worsening eye symptoms to your healthcare provider. Your healthcare provider may suggest an ophthalmological examination.

May increase the risk of developing eosinophilic conditions. Tell your doctor if you develop a red or purple rash, shortness of breath, or tingling or nerve pain in your hands or feet.

Your healthcare provider will decide if you need to continue with oral, topical, or inhaled corticosteroids while being treated with Dupilumab. These should be reduced gradually, do not discontinue without your doctor’s advice.

Report new onset or worsening joint pain or swelling to your healthcare provider. Further investigation may be required.

Any pre-existing worm or parasitic (helminth) infections should be treated before initiating Dupilumab. If patients become infected during treatment and do not respond to antihelminths, then discontinue dupilumab until the infection resolves.

Avoid the use of live vaccines. May reduce the immune response to other vaccinations.

It is not known if dupilumab is safe and effective for children with:

• atopic dermatitis under 6 months of age
• asthma under 6 years of age
• chronic rhinosinusitis with nasal polyposis under 18 years of age.
• eosinophilic esophagitis under 1 year of age, or who weigh less than 33 pounds (15 kg)
• prurigo nodularis under 18 years of age.

Before taking

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

• have an allergy to dupilumab
• have eye problems
• a parasite infection (such as roundworms or tapeworms)
• are scheduled to receive any vaccinations. You should not receive a live vaccine right before and during treatment
• if you use dupilumab to treat eczema or chronic rhinosinusitis with nasal polyposis, tell your doctor if you also have asthma
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known whether dupilumab will harm your unborn baby. There is a pregnancy exposure registry for women who use dupilumab during pregnancy. Your healthcare provider can enroll you in this registry or you can enroll yourself or get more information about the registry by calling 1-877-311-8972 or going to https://mothertobaby.org/ongoing-study/dupixent/

Breastfeeding

It is not known whether dupilumab passes into breast milk.

How should I use dupilumab?

Use dupilumab exactly as prescribed by your doctor. Follow all directions on your dupilumab label and package insert.

Dupilumab is not a rescue medicine for asthma attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

• A healthcare provider may teach you how to properly use the medication by yourself. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all the instructions.

Dupilumab is injected under the skin, usually once every 2 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 pre-filled pen is for use in adults and children 2 years and older. The pre-filled syringe is for use in adults and children 6 months and older.
• The dupilumab 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.

This drug can be used with or without topical corticosteroids.

Topical calcineurin inhibitors may be used but should be reserved for problem areas only (e.g., face, neck, intertriginous, and genital areas).

What happens if I miss a dose?

If you miss your injection by 7 days or less, use the missed dose as soon as you remember and then start a new every-week dose schedule from the time you remember.

If your dose schedule is every other week and you miss a dose of dupilumab give the 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 injection.

If your dose schedule is every 4 weeks and you miss a dose of dupilumab, give the 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 injection.

Do not use two doses at one time.

What happens if I overdose?

If you inject too much dupilumab, 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 dupilumab?

Do not receive a "live" vaccine while using dupilumab. 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 are the side effects of dupilumab?

Get emergency medical help if you have signs of an allergic reaction to dupilumab: hives, rash, itching; fever, swollen glands, joint pain; feeling light-headed, difficulty breathing; swelling of your face, lips, tongue, or throat.

Dupilumab may cause serious side effects. Call your doctor at once if you have:

• Eye problems, including 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 dupilumab 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 have a rash, chest pain, worsening shortness of breath, a feeling of pins and needles or numbness of your arms or legs, or persistent fever
• Joint aches and pain. 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.

The most common side effects of dupilumab include:

• pain, swelling, burning, or irritation where an injection was given
• dizziness
• trouble sleeping (insomnia)
• toothache
• high counts of a certain white blood cell (eosinophilia)
• eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision and pain
• dry eyes or watery eyes
• throat pain (oropharyngeal pain)
• cold sores or fever blisters on your lips or in your mouth
• fast pulse
• blood vessel inflammation
• fever
• chest pain
• trouble breathing
• skin rash, skin sores, or blisters
• numbness, or prickly feeling in your arms or legs
• stomach pain, nausea, vomiting, diarrhea
• cold symptoms such as stuffy nose, sneezing, sore throat
• joint or muscle pain
• parasitic (helminth) infections.

The following additional side effects have been reported with dupilumab:

• facial rash or redness

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 dupilumab. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What other drugs will affect dupilumab?

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.

This list is not complete. Other drugs may interact with dupilumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

You may store a prefilled syringe or injection pen at cool room temperature for up to 14 days. Do not store above 25°C (77°F). Throw the medicine away if not used within 14 days. Do not put it back into the refrigerator.

Do not expose dupilumab to heat or direct sunlight. Do NOT freeze. Do NOT shake.

Ingredients

Active: dupilumab.

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

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

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

Manufacturer

Sanofi-aventis U.S. LLC and Regeneron Pharmaceuticals Inc.

Popular FAQ

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Further information

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