Dupilumab

Generic name: dupilumab
Brand name: Dupixent
Dosage form: subcutaneous injection
Drug class: Interleukin inhibitors

Medically reviewed by  A Ras MD.

What is dupilumab?

Dupilumab is used to treat eczema. It is used to treat asthma. Dupilumab is also used to treat long-term sinus problems with nose polyps.

For asthma, do not use dupilumab to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.

Description

Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa.

Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture.

DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex.

Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9.

Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9.

Each 100 mg pre-filled syringe delivers 100 mg dupilumab in 0.67 mL which also contains L-arginine hydrochloride (3.5 mg), L-histidine (2.1 mg), polysorbate 80 (1.3 mg), sodium acetate (0.7 mg), sucrose (34 mg), and water for injection, pH 5.9.

Mechanism of Action

Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor.

Inflammation driven by IL-4 and IL-13 is an important component in the pathogenesis of asthma, atopic dermatitis, CRSwNP, and EoE. Multiple cell types that express IL-4Rα (e.g., mast cells, eosinophils, macrophages, lymphocytes, epithelial cells, goblet cells) and inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines, chemokines) are involved in inflammation. Blocking IL-4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. The mechanism of dupilumab action has not been definitively established.

Before taking dupilumab, tell your doctor:

• If you are allergic to dupilumab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine 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 dupilumab 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 are some things I need to know or do while I take dupilumab?

For all uses of dupilumab:

• Tell all of your health care providers that you take dupilumab. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before getting any vaccines. Use of some vaccines with dupilumab may either raise the chance of an infection or make the vaccine not work as well.
• If you are switching to dupilumab from a steroid, do not stop taking the steroid all of a sudden. The dose of the steroid may need to be slowly lowered to avoid side effects. Talk with the doctor.
• If you have asthma, do not change or stop your asthma drugs without talking with your doctor.
• Some people at high risk for parasite infections have gotten a parasite infection after taking dupilumab. Your doctor may test your stool to see if you have a parasite infection. Talk with your doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

For asthma:

• Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.

How is dupilumab best taken?

Use dupilumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Do not give into skin within 2 inches of the belly button.
• Move the site where you give the shot with each shot.
• If the dose is more than 1 injection, give the injections into 2 different places.
• If stored in a refrigerator, let dupilumab come to room temperature before using. If you have the 200 mg syringe, leave it out for 30 minutes. If you have the 300 mg syringe, leave it out for 45 minutes. Check with the doctor or pharmacist if you are not sure how long to leave dupilumab at room temperature before using. Do not heat dupilumab.
• Do not shake.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Do not use if the solution is cloudy, leaking, or has particles.
• This medicine is colorless to a faint yellow. Do not use if the solution changes color.
• Each prefilled syringe is for one use only.
• Throw away any part left over after the dose is given.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it has been 7 days or more since the missed dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are the side effects of dupilumab that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all uses of dupilumab:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Swollen gland.
• Joint pain.
• Dizziness or passing out.
• Change in eyesight, eye pain, or very bad eye irritation.

For asthma:

• Trouble breathing that is new or worse.
• Chest pain.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• A burning, numbness, or tingling feeling that is not normal.
• Fever that does not go away.

What are some other side effects of dupilumab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.
• Throat pain.
• Cold sores.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out dupilumab?

• Store in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• If needed, you may store at room temperature for up to 14 days. Write down the date you take dupilumab out of the refrigerator. If stored at room temperature and not used within 14 days, throw dupilumab away.
• Protect from heat and sunlight.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.