Dupixent

Generic name: Dupilumab
Drug class: Interleukin inhibitors

Usage of Dupixent

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.

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.

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.

Before taking Dupixent

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.

Relate drugs

How to use Dupixent

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)

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.

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.

Disclaimer

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