Dupixent Pre-filled Pen is used in adults and children 6 months and older to treat moderate-to-severe eczema (atopic dermatitis) that cannot be controlled with topical medicines applied to the skin.

Dupixent Pre-filled Pen is also used in adults and children 6 years and older together with other medications to treat moderate-to-severe asthma that is not controlled with other asthma medicines.

Dupixent Pre-filled Pen is used only in adults to treat a condition called chronic rhinosinusitis (long-term sinus inflammation) that is associated with nasal polyps.

Dupixent Pre-filled Pen is used to treat eosinophilic esophagitis in adults and children 12 years and older, weighing at least 88 pounds (40 kilograms).

Dupixent Pre-filled Pen is also used to treat prurigo nodularis in adults.

Dupixent Pre-filled Pen may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Dupixent Pre-filled Pen is not a rescue medicine for asthma attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Dupixent Pre-filled Pen is injected under the skin, usually once every 2 to 4 weeks. Your first dose may be given in 2 injections.

A healthcare provider may teach you how to properly use the medication by yourself. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Do not shake the prefilled syringe or injection pen. Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Store Dupixent Pre-filled Pen in the original carton in the refrigerator. Protect from light and do not freeze.

Take a syringe or pen out of the refrigerator and let it reach room temperature for 30 to 45 minutes before injecting your dose. Leave the needle cap on until you are ready to inject your dose.

You may store a prefilled syringe or injection pen at cool room temperature for up to 14 days. Throw the medicine away if not used within 14 days. Do not put it back into the refrigerator.

Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.

The pre-filled pen is for use in adults and children 12 years and older. The pre-filled syringe is for use in adults and children 6 months and older.

Use a needle and syringe or pen only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

If you also use other medications to treat eczema or asthma, do not change your doses or stop using the other medications without your doctor's advice.

You should not use Dupixent Pre-filled Pen if you are allergic to it.

Dupixent Pre-filled Pen should not be given to a child younger than 6 years old to treat asthma, younger than 6 months old to treat eczema, or younger than 12 years old and weighing at least 88 pounds (40 kilograms) to treat eosinophilic esophagitis.

Tell your doctor if you have ever had:

• eye problems;

• a parasite infection (such as roundworms or tapeworms); or

• if you are scheduled to receive any vaccine.

If you use Dupixent Pre-filled Pen to treat eczema or chronic rhinosinusitis with nasal polyposis, tell your doctor if you also have asthma.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dupilumab on the baby.

If you miss your injection by 7 days or less, use the missed dose as soon as you remember and then go back to your regular injection schedule.

If you are more than 7 days late for the injection:

• For the every-other-week injection schedule: Skip the missed dose and use the medicine at your next scheduled injection time.

• For the every-4-weeks schedule: Start a new dosing schedule on the day you use the missed injection and use your next injection 4 weeks later.

Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using Dupixent Pre-filled Pen. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Get emergency medical help if you have signs of an allergic reaction: hives, rash, itching; fever, swollen glands, joint pain; feeling light-headed, difficult breathing; swelling of your face, lips, tongue, or throat.

Dupixent Pre-filled Pen may cause serious side effects. Call your doctor at once if you have:

• new or worsening eye pain or discomfort;

• vision changes;

• watery eyes (your eyes may be more sensitive to light);

• fast pulse;

• stomach cramps;

• feeling like something is in your eye; or

• blood vessel inflammation--fever, chest pain, trouble breathing, skin rash, numbness or prickly feeling in your arms or legs.

Common side effects of Dupixent Pre-filled Pen may include:

• pain, swelling, burning, or irritation where an injection was given;

• blood vessel inflammation;

• eye redness or itching, puffy eyelids;

• stomach pain, nausea, vomiting, diarrhea;

• sore throat;

• tooth pain;

• sleep problems (insomnia);

• cold symptoms such as stuffy nose, sneezing, sore throat;

• skin sores or blisters, itching, tingling, burning pain in your thigh or lower back;

• joint or muscle pain; or

• cold sores or fever blisters on your lips or in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• an oral, inhaled, or topical steroid medicine; or

• any medicine to treat asthma.

This list is not complete. Other drugs may affect Dupixent Pre-filled Pen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.