Dupilumab (Dupixent) is a biological medication called a monoclonal antibody that is used to treat atopic diseases.

Dupilumab helps treat atopic diseases by stopping the inflammation linked to these diseases.

Dupilumab works by binding to a protein in your body called interleukin-4 receptor alpha (IL-4Rɑ), which makes it an IL-4Rɑ antagonoist. This blocks the action of two proteins called interleukin-4 (IL-4) and interleukin-13 (IL-13), which are involved in signaling the body to release substances that cause inflammation. It helps to stop inflammation before it even begins.

Dupilumab was approved by the US Food and Drug Administration (FDA) in 2017. The FDA has not approved any biosimilars of dupilumab which are drugs that have the same effect on a person, but which are only highly similar and not identical.

What is dupilumab used for?

Dupilumab is a prescription medicine used:

• to treat adults and children 6 months of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. Dupilumab 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. Dupilumab helps prevent severe asthma attacks (exacerbations) and can improve your breathing. Dupilumab may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. Dupilumab is not used to treat sudden breathing problems.
• with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled.
• to treat adults and children 12 years of age and older, who weigh at least 88 pounds (40 kg), with eosinophilic esophagitis (EoE).

It is not known if dupilumab is safe and effective in 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 12 years of age and who weigh at least 88 pounds (40 kg).

• See the detailed "Instructions for Use" that comes with dupilumab for information on how to prepare and inject dupilumab and how to properly store and throw away (dispose of) used dupilumab pre-filled syringes and pre-filled pens.
• Use dupilumab exactly as prescribed by your healthcare provider.
• Your healthcare provider will tell you how much dupilumab to inject and how often to inject it.
• Dupilumab comes as a single-dose pre-filled syringe with needle shield or as a pre-filled pen.
  • The dupilumab pre-filled pen is only for use in adults and children 12 years of age and older.
  • The dupilumab pre-filled syringe is for use in adults and children 6 months of age and older.
• Dupilumab 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 dupilumab, you or your caregiver should receive training on the right way to prepare and inject dupilumab. Do not try to inject dupilumab until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that dupilumab be given by or under the supervision of an adult. In children younger than 12 years of age, dupilumab should be given by a caregiver.
• Your healthcare provider may prescribe other medicines to use with dupilumab. Use the other prescribed medicines exactly as your healthcare provider tells you to.

• Atopic Dermatitis
  • Adults: The recommended dose of dupilumab is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week.
  • Pediatric patients 6 months to 5 years of age:

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

  • Pediatric patients 6 years to 17 years of age:

    Body weight	Initial loading dose	Subsequent doses
    15 to less than 30 kg	600 mg (two 300 mg injections)	300 mg every 4 weeks
    30 to less than 60 kg	400 mg (two 200 mg injections)	200 mg every other week
    60 kg or more	600 mg (two 300 mg injections)	300 mg every other week

• Asthma
  • Dosage in adult and pediatric patients 12 years and older

    Initial loading dose	Subsequent doses
    400 mg (two 200 mg injections)	200 mg every 2 weeks
    Or
    600 mg (two 300 mg injections)	300 mg every 2 weeks

    Dosage for patients with oral corticosteroid-dependent asthma or with co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid chronic rhinosinusitis with nasal polyposis

    Initial loading dose	Subsequent doses
    600 mg (two 300 mg injections)	300 mg every 2 weeks

  • Dosage in pediatric patients 6 year to 11 years of age

    Body weight	Initial dose and subsequent doses
    15 to less than 30 kg	100 mg every other week Or 300 mg every four weeks
    ≥30 kg	200 mg every other week

    For pediatric patients 6 to 11 years old with asthma and co-morbid moderate-to-severe atopic dermatitis follow the dosing instructions listed above for pediatric patients with atopic dermatitis

• Chronic Rhinosinusitis with Nasal Polyposis
  • Recommended dosage for adult patients is 300 mg given every other week.
• Eosinophilic esophagitis
  • Recommended dosage for adult and pediatric patients 12 years of age and older, weighing at least 40 kg, is 300 mg given every week.

Do not use dupilumab if you are allergic to dupilumab or to any of the ingredients in dupilumab. See below for a complete list of ingredients in dupilumab.

What should I tell my doctor before using dupilumab?

Before using dupilumab, 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 dupilumab.

If your dose schedule is every week and you miss a dose of dupilumab: Give the dupilumab injection as soon as possible and start a new every week dose schedule from the time you remember to take your dupilumab injection.

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

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

If you inject too much dupilumab (overdose), get medical help or contact a Poison Center expert right away at 1-800-222-1222.

 Serious side effects of dupilumab include:

• Allergic reactions. Dupilumab can cause allergic reactions that can sometimes be severe. Stop using dupilumab 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
  • swelling of the face, lips, mouth, tongue, or throat
  • hives
  • itching
  • nausea or vomiting
  • fainting, dizziness, feeling lightheaded
  • joint pain
  • skin rash
  • cramps in your stomach-area
• 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 dupilumab. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by dupilumab. Tell your healthcare provider right away if you have:
  • rash
  • worsening shortness of breath
  • persistent fever
  • chest pain
  • a feeling of pins and needles or numbness of your arms or legs
• Joint aches and pain. Joint aches and pain can happen in people who use dupilumab. 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 dupilumab if you develop joint symptoms.

The most common side effects of dupilumab include:

• injection site reactions
• eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision
• pain in the throat (oropharyngeal pain)
• cold sores in your mouth or on your lips
• high count of a certain white blood cell (eosinophilia)
• trouble sleeping (insomnia)
• toothache
• gastritis
• joint pain (arthralgia)
• 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 FDA at 1-800-FDA-1088.

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 or CRSwNP, 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.