Dupixent is an injectable prescription medicine used to treat a number of inflammatory conditions.

Dupixent works to inhibit the inflammatory response by binding to a protein called interleukin-4 (IL-4) receptor alpha subunit (IL-4Ra)] that causes inflammation.

What is Dupixent used to treat?

Dupixent is used in adults and children 6 months and older to treat moderate-to-severe eczema (atopic dermatitis). It is used in patients with 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.

Dupixent is used in adults and children 6 years and older to treat moderate-to-severe asthma in adults and children who are at least 6 years old. It is used with other asthma medicines for the maintenance treatment of patients whose asthma is not controlled with their current medicines.

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

Dupixent is used to treat eosinophilic esophagitis in adults and children 12 years of age and older, who weigh at least 88 pounds (40 kg).

Dupixent is also used to treat adults with prurigo nodularis.

Follow all directions on your Dupixent label and package insert. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

To make sure Dupixent is safe for you, tell your doctor if you have:

• an allergy to dupilumab
• if you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

Dupilumab may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Dupixent with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Dupixent exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Dupixent 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 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 this medicine 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.

Usual Adult Dose for Atopic Dermatitis:

Initial dose: 600 mg subcutaneously (two 300 mg injections at different sites)
Maintenance dose: 300 mg subcutaneously every other week

Comments:
-This drug can be used with or without topical corticosteroids.
-Topical calcineurin inhibitors may be used but should be reserved for problem areas only (e.g., face, neck, intertriginous, genital areas).

Use: For moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies are not advisable

Usual Adult Dose for Asthma:

400 mg subcutaneously (two 200 mg injections at different sites) initially, followed by 200 mg subcutaneously every other week
OR
600 mg subcutaneously (two 300 mg injections at different sites) initially, followed by 300 mg subcutaneously every other week

For patients requiring concomitant oral corticosteroids or with comorbid moderate-to-severe atopic dermatitis:
600 mg subcutaneously initially followed by 300 mg subcutaneously every other week.

Use: As add-on maintenance treatment in patients 12 years and older with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid dependent asthma

Usual Adult Dose for Sinusitis:

300 mg subcutaneously every other week

Use: As an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP)

Usual Adult Dose for Eosinophilic Esophagitis:

300 mg subcutaneously every week

Use: For the treatment of adults with eosinophilic esophagitis

Usual Adult Dose for Prurigo Nodularis:

Initial dose: 600 mg subcutaneously (two 300 mg injections at different sites)
Maintenance dose: 300 mg subcutaneously every other week

Use: For the treatment of adults with prurigo nodularis

Usual Pediatric Dose for Atopic Dermatitis:

6 months to 5 years of age:
5 to less than 15 kg:
-Initial dose: 200 mg subcutaneously (one 200 mg injection) every 4 weeks
-Maintenance dose: 200 mg subcutaneously (one 200 mg injection) every 4 weeks
15 to less than 30 kg:
-Initial dose: 300 mg subcutaneously (one 300 mg injection) every 4 weeks 
-Maintenance dose: 300 mg subcutaneously (one 300 mg injection) every 4 weeks

6 years to 17 years of age:
15 to less than 30 kg:
-Initial dose: 600 mg subcutaneously (two 300 mg injections at different sites)
-Maintenance dose: 300 mg subcutaneously every 4 weeks
30 to less than 60 kg:
-Initial dose: 400 mg subcutaneously (two 200 mg injections at different sites)
-Maintenance dose: 200 mg subcutaneously every other week
60 kg or greater:
-Initial dose: 600 mg subcutaneously (two 300 mg injections at different sites)
-Maintenance dose: 300 mg subcutaneously every other week

Comments:
-This drug can be used with or without topical corticosteroids.
-Topical calcineurin inhibitors may be used but should be reserved for problem areas only (e.g., face, neck, intertriginous, genital areas).

Use: For patients 6 months to 17 years with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies are not advisable

Usual Pediatric Dose for Asthma:

6 to 11 years:
15 to less than 30 kg
-Initial dose and subsequent doses: 100 mg every other week or 300 mg every four weeks
30 kg and over
-Initial dose and subsequent doses: 200 mg every other week
12 years and older:
-see adult dosage

Comments:
-For pediatric patients (6 to 11 years old) with asthma and co-morbid moderate-to-severe atopic dermatitis, follow the recommended dosage for pediatric atopic dermatitis for the initial loading dose.

Use: add-on maintenance treatment of patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.

Usual Pediatric Dose for Eosinophilic Esophagitis:

300 mg subcutaneously every week

Use: for the treatment of pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE)

You should not use Dupixent if you are allergic to dupilumab.

Dupixent should not be given to a child younger than 6 months of age to treat eczema, younger than 6 years of age to treat asthma, under 12 years of age and weighing at least 88 pounds (40 kilograms) to treat eosinophilic esophagitis, or younger than 18 years of age to treat chronic rhinosinusitis with nasal polyposis or prurigo nodularis.

To make sure Dupixent is safe for you, tell your doctor if you have:

• eye problems;

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

• if you are scheduled to receive any vaccine.

If you use Dupixent 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. 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 to Dupixent: hives, rash, itching; fever, swollen glands, joint pain; feeling light-headed, difficult breathing; swelling of your face, lips, tongue, or throat.

Dupixent 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 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 interact with dupilumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.