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DUPIXENT- dupilumab injection, solution


  1. Patient Information
  2. Dupixent Is A Prescription Medicine Used:
  3. Dupixent Can Cause Serious Side Effects, Including:
  4. The Most Common Side Effects Of Dupixent Include:
  5. Active Ingredient:
  6. Inactive Ingredients:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Pregnancy Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. Encourage participation in the registry.[

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 amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing.
  • with other medicines to treat chronic rhinosinusitis with nasal polyposis in adults whose disease is not controlled.
  • DUPIXENT works by blocking two proteins that contribute to a type of inflammation that plays a major role in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.
  • DUPIXENT is not used to treat sudden breathing problems.
  • It is not known if DUPIXENT is safe and effective in children with atopic dermatitis or asthma under 12 years of age.
  • It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.

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

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
  • Eye problems.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

The Most Common Side Effects Of Dupixent Include: 

  • injection site reactions
  • eye and eyelid inflammation, including redness, swelling, and itching
  • 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)

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.

General information about the safe and effective use of DUPIXENT.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DUPIXENT for a condition for which it was not prescribed. Do not give DUPIXENT to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about DUPIXENT that is written for health professionals.

Active Ingredient: 

dupilumab

Inactive Ingredients: 

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

REGENERONSANOFIGENZYME

Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591 U.S. License No. 1760

Marketed by: sanofi-aventis U.S. LLC (Bridgewater, NJ 08807) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591)

DUPIXENTis a registered trademark of Sanofi Biotechnology / 2019 Regeneron Pharmaceuticals, Inc. / sanofi-aventis U.S. LLC. All rights reserved.

For more information about DUPIXENT, go to www.DUPIXENT.com or call 1-844-DUPIXENT (1-844-387-4936).



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