DUPIXENT is indicated for the treatment of adults and children aged 6 months and older with moderate-to-severe atopic dermatitis (eczema) 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.

Fill out your personalized doctor discussion guide and ask your doctor if DUPIXENT may be right for you.

DUPIXENT works with your body’s immune system to help reduce inflammation contributing to your eczema, which may help reduce your uncontrolled moderate-to-severe eczema (atopic dermatitis) symptoms and may give you noticeably clearer skin.

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

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

• have eye problems.
• have a parasitic (helminth) infection.
• are scheduled to receive any vaccinations. You should not receive a "live vaccine" right before and during treatment with DUPIXENT.
• are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
  • A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information 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 if you have atopic dermatitis and asthma and 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.

The efficacy of DUPIXENT has been studied in 3 clinical trials with approximately 2,100 adults with uncontrolled moderate-to-severe atopic dermatitis.

• DUPIXENT was evaluated in these studies when taken alone and when taken with topical corticosteroids.

The efficacy of DUPIXENT has been studied in a 16-week clinical trial with 251 teens ages 12-17 years with uncontrolled moderate-to-severe atopic dermatitis.

The efficacy of DUPIXENT has been studied in a 16-week clinical trial with 367 children ages 6-11 years with uncontrolled severe atopic dermatitis also taking topical corticosteroids.

The efficacy of DUPIXENT has been studied in a 16-week clinical trial with 162 children ages 6 months-5 years with uncontrolled moderate-to-severe atopic dermatitis also taking topical corticosteroids.

Patients enrolled in these studies were not well controlled with prescription therapies used on the skin (topical), or could not use topical therapies.

Individual responses to DUPIXENT can vary. Your experience with DUPIXENT may be different.

DUPIXENT has been studied in multiple clinical trials with various age groups—Adults (ages 18+ years), Teens (ages 12-17 years), Children (ages 6-11 years), and Young Children (ages 6 months-5 years)—who suffer from uncontrolled moderate-to-severe eczema (atopic dermatitis).

In each clinical trial, results were measured at 16 weeks, with each age group taking DUPIXENT achieving visible skin improvement in that time compared to patients who were not administered DUPIXENT.

DUPIXENT can cause serious side effects, including:

• Allergic reactions. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms:

• Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an eye exam if needed.
• Joint aches and pain. Joint aches and pain can happen in people who use DUPIXENT. Some people have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms.

The most common side effects of DUPIXENT include:

• injection site reactions
• eye and eyelid Inflammation, including redness, swelling, and itching, sometimes with blurred vision 
• cold sores in your mouth or on your lips
• 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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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

• have eye problems.
• have a parasitic (helminth) infection.
• are scheduled to receive any vaccinations. You should not receive a "live vaccine" right before and during treatment with DUPIXENT.
• are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
  • A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information 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 if you have atopic dermatitis and asthma and 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.

DUPIXENT works by blocking the signaling of two proteins that contribute to a type of inflammation that plays a major role in atopic dermatitis.

DUPIXENT affects the body’s immune system to help reduce the inflammation associated with moderate-to-severe eczema, which may reduce symptoms such as rash, redness, and itch. It is not known if DUPIXENT can affect the immune response to parasitic (helminth) infections.

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 healthcare provider. In teens 12 years of age or older, it is recommended that DUPIXENT be administered by or under the supervision of an adult. In children younger than 12 years of age, DUPIXENT should be given by a caregiver. The DUPIXENT pre-filled pen is only for use in adults and children 12 years of age and older. The DUPIXENT pre-filled syringe is for use in adults and children 6 months of age and older.

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

The recommended dose of DUPIXENT is specified in the table below. DUPIXENT can be used with or without topical corticosteroids.

*For children 6 months to 5 years of age with atopic dermatitis, no initial loading dose is recommended.

• In adults and children 6+ years and older, your initial loading dose of DUPIXENT is 2 injections under the skin (subcutaneous injection) at different injection sites. After that, it is taken as 1 injection every 2 weeks or every 4 weeks, depending on your age and weight at different injection sites. For children aged 6 months to 5 years, it is taken as 1 injection every 4 weeks with no initial loading dose recommended.
• Talk to your healthcare professional 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 or DUPIXENT Pre-filled Pens prior to taking the drug.
   

Get supplemental injection support after your doctor shows you the right way to take DUPIXENT.

GET THE PRE-FILLED SYRINGE INSTRUCTIONS FOR USE

GET THE PRE-FILLED PEN (AGES 12+ YEARS) INSTRUCTIONS FOR USE

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

If your dose schedule is every 4 weeks and you miss a dose of DUPIXENT: Give the DUPIXENT injection within 7 days from the missed dose, then continue with your original schedule. If the missed dose is not given within 7 days, start a new every 4 week dose schedule from the time you remember to take your DUPIXENT injection.

Speak with your healthcare provider before making any change to your treatment regimen.

No, you should always follow your healthcare provider’s instructions for dosing and how to give injections.

Moderate-to-severe eczema is a chronic disease with no known cure. Each person may respond differently to DUPIXENT.
Speak with your healthcare provider if you have questions regarding how long you’ll need to take DUPIXENT.

There are no known foods you should avoid while taking DUPIXENT. If you suspect a side effect with a particular food while taking DUPIXENT, notify your healthcare provider.

Be sure to speak with your healthcare provider.

DUPIXENT should be refrigerated at 36°F to 46°F in the original carton to protect from light. If necessary, DUPIXENT may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. Do not store above 77°F (25°C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded.

Do not expose DUPIXENT to heat or direct sunlight.

Do not freeze. Do not shake.

Please refer to the DUPIXENT Instructions for Use for complete storage instructions.

Whether you are traveling or not, it’s important to store the syringes in the original carton to protect it from light.

Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. If necessary, pre-filled syringes and pre-filled pens may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. Do not store above 77°F (25°C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded.

Yes. You can continue to receive injection support from your doctor or our Injection Support Center, or if your doctor decides that you or your caretaker can give injections, your doctor will train you. Do not self-adminster DUPIXENT unless you have been trained by a doctor. Patients enrolled in DUPIXENT MyWay® will also have access to their Nurse Educator to help with supplemental training.

For more information about DUPIXENT support resources, you can enroll in DUPIXENT MyWay®, a program that can provide:

• Tips and tools to help with your uncontrolled moderate-to-severe eczema (atopic dermatitis).
• Supplemental injection training. Your doctor will show you the proper procedure first and decide whether you can self-inject.
• Financial support for eligible commercially insured patients.
• Assistance with insurance questions.
• Assistance locating a pharmacy that can dispense your DUPIXENT prescription.

Sign up or call a support coordinator at 1-844-DUPIXENT (1-844-387-4936) to learn more.

You can use our Cost and Coverage Tool to learn more about cost information for your insurance situation. For the most accurate information regarding your cost and dispensing of DUPIXENT, speak directly with your insurance provider who knows the details of your plan.

Certain retail pharmacies or specialty pharmacies can fill your prescription. These pharmacies can:

• Coordinate directly with your doctor.
• Manage the handling and service requirements of specialty drugs.
• Ship your medication directly to your home in a special cooler to help make sure the correct temperature is maintained through the process.
• Stay in contact with you and your doctor throughout the treatment.

Notify your pharmacy. In fact, when you take medications that require refills regularly over time, it’s always good to periodically check that your pharmacy has your most up-to-date insurance information on file. This can help you avoid potential delays in getting your prescription.

Contact 1-844-DUPIXENT (1-844-387-4936) to speak to a DUPIXENT MyWay® Nurse Educator if you have additional questions.

With the DUPIXENT MyWay Copay Card, eligible, commercially insured patients may pay as little as $0* copay per fill of DUPIXENT (maximum of $13,000 per patient per calendar year) if they meet the eligibility requirements, including:

• Have commercial insurance, including health insurance exchanges, federal employee plans, or state employee plans
• Are a resident of the 50 United States, the District of Columbia, Puerto Rico, Guam or the USVI
• Are prescribed DUPIXENT for an indication approved by the US Food and Drug Administration

*Approval is not guaranteed. Program has an annual maximum of $13,000. THIS IS NOT INSURANCE. Not valid for prescriptions paid, in whole or in part, by Medicaid, Medicare, VA, DOD, TRICARE, or other federal or state programs including any state pharmaceutical assistance programs. This program is not valid where prohibited by law, taxed or restricted. DUPIXENT MyWay reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Any savings provided by the program may vary depending on patients' out-of-pocket costs. The program is intended to help patients afford DUPIXENT. Patients may have insurance plans that attempt to dilute the impact of the assistance available under the program. In those situations, the program may change its terms. Additional terms and conditions apply.

You can request copay reimbursement if:

• Your health plan did not accept your Copay Card
• You paid a copay for DUPIXENT before enrolling in DUPIXENT MyWay® and you meet other program requirements

Submit your request for reimbursement.

Through the Patient Assistance Program, qualified patients who are uninsured or whose insurance does not cover DUPIXENT could receive DUPIXENT at no cost.

Those who may qualify must be at least 18 years of age or older, a resident of the 50 United States, the District of Columbia, Puerto Rico, Guam or the USVI, and demonstrate a financial need with a total annual adjusted gross income of $100,000 or less.

The DUPIXENT MyWay team will research each patient’s situation and determine eligibility. For more information, call 1-844-DUPIXENT (1-844-387-4936), option 1.