DUPIXENT is a new type of medication for treating resistant atopic dermatitis/ eczema.

What is DUPIXENT?

DUPIXENT is an interleukin-4 receptor alpha antagonist indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

DUPIXENT is the first biologic medication approved by the FDA for adults with moderate-to-severe eczema (atopic dermatitis) who are not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT is not a steroid and can be taken with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 18 years of age.

Atopic Dermatitis Skin

Immune systems of those with eczema may produce more inflammation than normal

How does DUPIXENT work?

The flare-ups of eczema you see and feel on your skin can be caused in part by

the inflammation happening beneath the surface. DUPIXENT works from

the inside, and is the first treatment of its kind that can help you continuously

manage your uncontrolled moderate-to-severe atopic dermatitis (eczema) over time, even between flares when your skin may look clear.

What are the clinical results?

DUPIXENT was studied in 3 clinical trials with more than 2,100 adults with uncontrolled moderate-to-severe eczema (atopic dermatitis).

What you should know about the patients in these studies:

52% had moderate atopic dermatitis

48% had severe atopic dermatitis

Average age ≈ 38 years

Average duration of the disease ≈ 28 years

Average body surface area involvement ≈ 55%

In two 16-week clinical trials with DUPIXENT when used alone compared to a placebo:

Nearly half of patients saw 75% skin improvement and some even saw 90% improvement.

Almost 4 times more patients taking DUPIXENT saw clear or almost clear skin as compared with those not taking DUPIXENT (37% taking DUPIXENT as compared to 10% taking placebo)

Patients experienced significant itch reduction, some patients as early as 2 weeks

The most common side effects include injection site reactions, pain in the throat (oropharyngeal pain) and cold sores in your mouth or on your lips. Eye and eyelid inflammation, including redness, swelling and itching have been seen in patients who have atopic dermatitis.

What is the precautions before taking DUPIXENT?

Before using DUPIXENT, tell your doctor about all your medical conditions, including if you:

  • have eye problems (if you also have atopic dermatitis)
  • have a parasitic (helminth) infection
  • are taking oral, topical, or inhaled corticosteroid medicines. Do not stop taking your corticosteroid medicines unless instructed by your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine to come back.
  • are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with DUPIXENT.
  • 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.

Where is DUPIXENT injected?

DUPIXENT can be injected into the thigh, stomach (except for the 2 inches around the belly button) or outer area of the upper arm (if caregiver injects). A different site should be chosen each time DUPIXENT is injected. Follow your doctor's instructions and read the Instructions for Use for full details on preparation, administration and disposal of your injection.

How is DUPIXENT taken?

DUPIXENT is given as an injection under the skin (subcutaneous injection) at different injection sites. Do not try to inject DUPIXENT until you have been shown the right way by your doctor.

The recommended dose of DUPIXENT for adult patients is an initial dose of 400mg/ 600 mg (two 200mg/ 300 mg injections), followed by 200mg/ 300 mg given every other week.

Talk to your doctor and see the detailed Instructions for Use that comes with DUPIXENT for information on how to prepare and inject DUPIXENT and how to properly store and throw away (dispose of) used DUPIXENT Pre-filled Syringes prior to taking the drug.

What are the possible side effects of DUPIXENT?

The most common side effects of DUPIXENT include:

  • Injection site reactions
  • Pain in the throat (oropharyngeal pain)
  • Cold sores in your mouth or on your lips
  • Eye and eyelid inflammation, including redness, swelling and itching have been seen in patients with atopic dermatitis
  • Eye problems. If you have atopic dermatitis, tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.
  • 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 of your arms or legs

DUPIXENT can cause serious side effects, including:

  • Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. 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

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the doctor.

 

How long do I have to take Dupixent?

Because of the chronic (recurring) nature of atopic dermatitis, you must remain on Dupixent to continue the clinical benefits of the drug.

Who should not use DUPIXENT?

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

For women who is pregnant or planning for pregnant and who is breastfeeding or planning for breastfeeding, are pregnant or plan to become pregnant. There is not enough clinical evidence to support its use. Please consult your doctor for medical advice.