Dupixent (dupilumab)

Dupixent is a prescription medicine used:

• to treat people aged 12 years 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. Dupixent can be used with or without topical corticosteroids.
• with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in people aged 12 years 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 number of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing.
• Dupixent works by blocking two proteins that contribute to a type of inflammation that plays a major role in atopic dermatitis and asthma.
• Dupixent is not used to treat sudden breathing problems.
• It is not known if Dupixent is safe and effective in children with atopic dermatitis under 12 years of age.
• It is not known if Dupixent is safe and effective in children with asthma under 12 years of age.

Dupixent can cause serious side effects, including:

• Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. 
• Eye problems. If you have atopic dermatitis, tell your healthcare provider if you have any new or worsening eye problems, including eye pain or vision changes.
• 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. It is not known whether this is caused by Dupixent. Tell your healthcare provider right away if you have:
  • rash
  • shortness of breath
  • persistent fever
  • chest pain
  • a feeling of pins and needles or numbness in your arms or legs

Stop using Dupixent and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

• breathing problems
• fever
• general ill feeling
• swollen lymph nodes
• swelling of the face, mouth, and tongue
• hives
• itching
• fainting, dizziness, feeling lightheaded (low blood pressure)
• joint pain
• skin rash

The most common side effects of Dupixent include:

• injection site reactions
• eye and eyelid inflammation, including redness, swelling, and itching (if you also have atopic dermatitis)
• pain in the throat (oropharyngeal pain)
• cold sores in your mouth or on your lips

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.

Dupixent is administered by subcutaneous injection.

Atopic Dermatitis

The recommended dose of Dupixent for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week.

The recommended dose of Dupixent for patients 12 to 17 years of age is specified in Table 1.

Table 1: Dose of Dupixent for Subcutaneous Administration in Adolescent Patients

Concomitant Topical Therapies

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, intertriginous and genital areas.

Asthma

The recommended dose of Dupixent for adults and adolescents (12 years of age and older) is:

• an initial dose of 400 mg (two 200 mg injections) followed by 200 mg given every other week or
• an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week
• For patients with oral corticosteroids-dependent asthma, or with co-morbid moderate-to-severe atopic dermatitis for which Dupixent is indicated, start with an initial dose of 600 mg followed by 300 mg given every other week

Live Vaccines

Avoid the use of live vaccines in patients treated with Dupixent.

Non-Live Vaccines

Immune responses to vaccination were assessed in a study in which subjects with atopic dermatitis were treated once weekly for 16 weeks with 300 mg of dupilumab (twice the recommended dosing frequency). After 12 weeks of Dupixent administration, subjects were vaccinated with a Tdap vaccine (Adacel®) and a meningococcal polysaccharide vaccine (Menomune®). Antibody responses to tetanus toxoid and serogroup C meningococcal polysaccharide were assessed 4 weeks later. Antibody responses to both the tetanus vaccine and meningococcal polysaccharide vaccine were similar in dupilumab-treated and placebo-treated subjects. Immune responses to the other active components of the Adacel and Menomune vaccines were not assessed.

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

• are pregnant or plan to become pregnant. It is not known whether Dupixent will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known whether Dupixent passes into your breast milk.