Generic Name: dupilumab
Dosage Form: Injection
Date of Approval: March 28, 2017
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Atopic Dermatitis
FDA Approves Dupixent
The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) Injection, an interleukin-4 receptor alpha antagonist indicated for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
Read this Patient Information before you start treatment, and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is Dupixent?
- Dupixent is a prescription medicine used to treat adults 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.
- It is not known if this medicine is safe and effective in children.
Who should not use Dupixent?
Do not use Dupixent if you are allergic to dupilumab or to any of the ingredients listed at the end of this page.
Before using Dupixent
Before you start treatment, tell your healthcare provider about all your medical conditions, including if you:
- have eye problems
- have a parasitic (helminth) infection
- have asthma
- 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.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. If you have asthma and are taking asthma medicines, do not change or stop your asthma medicine without talking to your healthcare provider.
How should I use Dupixent?
- See the detailed Instructions for Use that comes with your prescription for information on how to prepare and administer the injection, and how to properly store and dispose of the used pre-filled syringes.
- Use this medicine exactly as prescribed by your healthcare provider.
- Dupixent comes as a single-dose pre-filled syringe, with or without needle shield. Your healthcare provider will prescribe the type that is best for you.
- Dupixent is given as an injection under the skin (subcutaneous injection).
- If your healthcare provider decides that you or a caregiver can give the injections, you or your caregiver should receive training on the right way to prepare and administer the injections. Do not try to use the syringes until you have been shown the right way by your healthcare provider.
- If you miss a dose, give the injection within seven days from the missed dose, continue with the orginial schedule. If the missed dose is not given within seven days, wait until the next scheduled dose.
- If you inject more than prescribed, call your healthcare provider right away.
- Your healthcare provider may prescribe other topical medicines to use during your treatment. Use the other prescribed topical medicines exactly as your healthcare provider tells you to.
Dupixent side effects
Dupixent can cause serious side effects, including:
- Allergic reactions. Stop treatment and go to the nearest hospital emergency room if you get any of the following symptoms:
- general ill feeling
- swollen lymph nodes
- 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.
The most common side effects include:
- injection site reactions
- eye and eyelid inflammation, including redness, swelling and itching
- 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. 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 this medicine for a condition for which it was not prescribed. Do not give it 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 that is written for health professionals.
What are the ingredients?
Active ingredient: dupilumab
Inactive ingredients: L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection.