Brief Summary of Important Patient Information about DUPIXENT® (dupilumab) Rx Only

(Du-pix’-ent)

injection, for subcutaneous use What is DUPIXENT?

• DUPIXENT is a prescription medicine used:

– with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent 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.

• DUPIXENT is not used to treat sudden breathing problems

• It is not known if DUPIXENT is safe and effective in children with asthma under 12 years of age.

Who should not use DUPIXENT?

Do not use DUPIXENT if you are allergic to dupilumab or to any of the ingredients in DUPIXENT. See the end of this summary of information for a complete list of ingredients in DUPIXENT.

What should I tell my healthcare provider before using DUPIXENT? Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:

• have a parasitic (helminth) infection

• 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.

Pregnancy Registry

There is a pregnancy exposure registry for women who take DUPIXENT during pregnancy to collect information about the health of you and your baby. Your healthcare provider can enroll you or you may enroll yourself. To get more information about the registry call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/.

• 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.

Especially tell your healthcare provider if you:

• are taking oral, topical, or inhaled corticosteroid medicines

• or use an asthma medicine

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.

How should I use DUPIXENT? • 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 prefilled syringes.

• Use DUPIXENT exactly as prescribed by your healthcare provider.

• Your healthcare provider will tell you how much DUPIXENT to inject and how often to inject it.

• 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 of DUPIXENT, you or your caregiver should receive training on the right way to prepare and inject DUPIXENT. Do not try to inject DUPIXENT until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that DUPIXENT be administered by or under supervision of an adult.

How should I use DUPIXENT? (continued)

• If you miss a dose of DUPIXENT, give the injection within 7 days from the missed dose, then continue with the original schedule. If the missed dose is not given within 7 days, wait until the next scheduled dose to give your DUPIXENT injection.

• If you inject more DUPIXENT than prescribed, call your healthcare provider right away.

• Your healthcare provider may prescribe other medicines to use with DUPIXENT. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the possible side effects of 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, or skin rash.

• Inflammation in 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, or a feeling of pins and needles or numbness of your arms or legs.

The most common side effects of DUPIXENT in patients with asthma

include: injection site reactions, pain in the throat (oropharyngeal pain), and high count of a certain white blood cell (eosinophilia).

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. Visit www.fda.gov/medwatch, or call 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.

This is a brief summary of the most important information about DUPIXENT. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for more information about DUPIXENT that is written for healthcare professionals.

For more information about DUPIXENT, go to WWW.DUPIXENT.COM or call 1-844-DUPIXENT (1-844-387-4936) What are the ingredients in DUPIXENT? Active ingredient: dupilumab

Inactive ingredients: L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection

Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591 U.S. License # 1760; Marketed by sanofi-aventis U.S. Llc,(bridgewater, NJ 08807) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591) / DUPIXENT is a registered trademark of Sanofi Biotechnology / ©2020 Regeneron Pharmaceuticals, Inc. /sanofi-aventis U.S. LLC. All rights reserved. Issue Date: August 2020