Generic Name: dupilumab (doo PIL us mab)
Brand Name: Dupixent
Drug class: Interleukin inhibitors
Dupixent (dupilumab) is used to treat moderate-to-severe eczema (atopic dermatitis) that cannot be controlled with topical medicines applied to the skin. Dupixent is used for eczema in adults and children at least 6 years old.
Dupixent is also used together with other medications to treat moderate-to-severe asthma that is not controlled with other asthma medicines. It is used for asthma in adults and children at least 12 years old.
Dupixent is used only in adults to treat a condition called chronic rhinosinusitis (long-term sinus inflammation) that is associated with nasal polyps.
Warnings
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.
Before taking this medicine
You should not use Dupixent if you are allergic to dupilumab.
Dupixent should not be given to a child younger than 12 years old to treat asthma, or younger than 6 years old to treat eczema.
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.
How should I use Dupixent?
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.
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.
Dosing information
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 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 Pediatric Dose for Atopic Dermatitis:
6 years or older:
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 years and older 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:
12 years and older:
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 6 years and older with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid dependent asthma
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Dupixent?
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), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Dupixent side effects
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.
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);
- 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 Dupixent side effects 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;
- sore throat;
- tooth pain;
- sleep problems (insomnia);
- joint 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.
What other drugs will affect Dupixent?
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.