Key takeaways
Dupixent (dupilumab) is an injectable medication used to treat certain allergic conditions including moderate to severe atopic dermatitis, certain types of severe asthma, and chronic rhinosinusitis with nasal polyposis.
Common side effects of Dupixent include injection site reactions, eye inflammation, infections, and joint pain. Serious side effects can include severe allergic reactions, serum sickness, keratitis, and blood vessel swelling.
Dupilumab can cause eye surface problems, ranging from dry eye to potentially serious conditions like keratitis, due to its impact on immune system activity and the depletion of mucus-secreting goblet cells.
To minimize the risk of Dupixent’s side effects, patients should follow prescription guidelines closely, communicate their medical history to healthcare providers, and monitor for and report any symptoms of adverse effects.
Common Dupixent side effects | Serious side effects | Eye surface problems | Anti-drug antibodies | How long do side effects last? | Warnings | Interactions | How to avoid side effects
Dupixent is a brand-name prescription drug used to treat some types of allergic conditions. It is prescribed to treat moderate to severe atopic dermatitis (a type of eczema); as maintenance treatment for certain types of severe asthma; and as maintenance treatment for chronic rhinosinusitis with nasal polyposis, an allergic condition with swelling and polyps in the nose and sinuses.
The active ingredient in Dupixent is dupilumab, a monoclonal antibody that partly blocks the ability of the body to activate immune cells in response to an allergen. Taken as an injection under the skin (subcutaneous injection) once every two or four weeks, Dupixent has a limited number of side effects, drug interactions, and restrictions. Some of these problems, however, can be serious, so it helps to review the side effects that may occur with Dupixent.
RELATED: What is Dupixent?
Common side effects of Dupixent
The most common side effects of Dupixent are:
- Injection site reactions
- Pink eye (conjunctivitis)
- Eye inflammation
- Herpes infection
- Joint pain
- Pain in the mouth and throat
- Excess white blood cells (eosinophilia)
- Dry eyes
- Itchy eyes
- Swollen eyelids (blepharitis)
- Gastritis
- Toothache
- Trouble sleeping
- Cold sores in the mouth or lips
- Parasitic infections (worms)
Serious side effects of Dupixent
The most serious side effects of Dupixent are:
- Severe allergic reactions
- Serum sickness (a kind of immune reaction)
- Swelling of the cornea (keratitis)
- Blood vessel swelling (vasculitis)
Dupixent and eye surface problems
Dupilumab can cause mild to severe problems with the surface of the eye. Dupilumab’s mechanism of action in blocking the immune system also depletes the cells on the surface of the eye, called goblet cells, which secrete mucus to keep the eye lubricated. As a result, people taking dupilumab can experience problems such as dry eye, itchy eyes, inflammation of the whites of the eye (conjunctivitis), inflammation of the cornea (keratitis), swelling of the eyelids (blepharitis), and infection.
Clinical trials showed a low incidence of conjunctivitis or keratitis. However, after Dupixent was approved and widely used, clinical experience showed the incidence ranged from one in three to as high as 70%. The incidence, however, is lower for those who are not being treated for atopic dermatitis or who are screened first by an eye doctor.
In simple terms, people taking dupilumab should expect to experience eye problems. Patients should familiarize themselves with the warning signs of conjunctivitis and keratitis and immediately contact a healthcare provider if there’s a problem, even if it’s mild. Keratitis is a potentially serious medical condition that can cause blindness, so early detection and treatment are critical. Most people experiencing mild eye problems can be treated with lubricating eye drops. Conjunctivitis or keratitis can be managed with topical corticosteroid eye drops. Severe cases may require that Dupixent be discontinued.
Dupixent and anti-drug antibodies (immunogenicity)
Immunogenicity is a side effect that occurs when the body forms antibodies to a drug. This is especially common with monoclonal antibody therapies like Dupixent. In essence, the body responds to the injected monoclonal antibodies as it would to the proteins in a vaccine, by producing anti-drug antibodies. Sometimes anti-drug antibodies have no effect, but in other cases, these antibodies can reduce the effectiveness of the drug. Worse, they can provoke a serious and potentially life-threatening hypersensitivity reaction such as serum sickness or anaphylaxis.
In clinical trials, anti-drug antibodies were recorded in 5% to 16% of people taking Dupixent. Approximately two percent (one in 50) developed neutralizing antibodies, that is, antibodies that bind to the drug and reduce its therapeutic effects. For this reason, people taking Dupixent may require regular blood tests to ensure they aren’t developing an immunity to the therapy. In rare cases, a healthcare provider may stop Dupixent treatment.
How long do Dupixent side effects last?
The most common side effects of Dupixent are injection site reactions and eye problems. Injection site reactions, such as redness and pain, typically improve on their own in one or two days.
RELATED: Dupixent face rash and redness: Causes and treatment
Eye problems may take longer to resolve, but most cases will not require that Dupixent be discontinued. It typically takes an average of seven weeks for Dupixent patients to experience eye problems. Mild cases can be managed with lubrication eye drops. Improvement will be obvious in a few days. More serious problems will require topical steroids and may require a few weeks to clear up.
Severe allergic reactions and inflammation of the cornea will require medical treatment and require days or weeks to get better. The most severe reactions may have lifelong complications. Severe keratitis can result in corneal blindness.
Dupixent contraindications and warnings
Abuse and dependence
The U.S. Food and Drug Administration (FDA) does not classify Dupixent as a drug with the potential for abuse. Dupixent does not cause physical dependence, and there are no known withdrawal effects.
Overdose
Although an overdose is unlikely, if too much Dupixent is injected, call a healthcare professional immediately.
Restrictions
Dupilumab has few restrictions. The only contraindications are known allergies to dupilumab or any of the inactive ingredients in the Dupixent injection. In addition, Dupixent is never to be used to treat an acute asthma attack, airway closure, or acute severe asthma.
Because dupilumab suppresses the immune system, people with parasitic worm (helminth) infections may not be able to fight off the infection even with treatment. People with an existing helminth infection will need to have that infection successfully treated before being able to take dupilumab. If a person experiences a helminth infection while taking Dupixent, the medicine may be stopped if deworming treatments don’t work.
Pregnancy and breastfeeding
There are no human studies or information to determine if it is safe for pregnant women to take Dupixent, but so far there have been no reports of any harm to a fetus. Pregnant women taking Dupixent are encouraged to enroll in a registry sponsored by the manufacturer.
Based on preliminary evidence, healthcare professionals cautiously believe Dupixent is safe to take while breastfeeding. Dupilumab is a large protein that is unlikely to be secreted into breast milk and, if it is, very likely to be broken down by an infant’s digestive system. Talk with your healthcare provider about risks and benefits if you are breastfeeding.
Children
Dupixent is FDA approved to treat children as young as 6 years of age for atopic dermatitis and asthma.
Seniors
In clinical trials, for the small number of seniors studied, Dupixent was as effective and safe in patients older than the age of 65 years as it was in younger adults.
Dupixent interactions
Like many monoclonal antibodies, Dupixent has few drug interactions. The most serious involve
- Live vaccines: Because dupilumab suppresses the immune system, there is a possibility that a live vaccine could cause an active infection. Healthcare professionals will avoid giving live vaccines to people taking Dupixent. Non-live vaccines can be taken safely, though they may be less effective.
- Corticosteroids: Dupixent is commonly and safely taken with corticosteroids to treat atopic dermatitis or asthma. However, if people with asthma are taking oral corticosteroids, reducing the dose of those corticosteroids could cause serious complications in people with high levels of one type of white blood cell called eosinophils.
Dupixent is also not used together with other monoclonal antibody treatments because of an increased risk of serious infections.
How to avoid Dupixent side effects
Although Dupixent has relatively few side effects, a handful of these adverse effects are common. Some might start as nuisances, such as dry eye, and grow into more serious problems. As with any prescription drug, people taking Dupixent can take steps to minimize side effects. More importantly, by knowing the right symptoms to watch for, people can avoid some of the more serious problems caused by Dupixent.
1. Tell the prescribing healthcare provider about all medical conditions
Preventing Dupixent side effects always starts with making sure the healthcare provider prescribing the medicine has a complete medical history. That’s because some of Dupixent’s adverse effects are more likely or more severe in people with pre-existing physical conditions, particularly:
- Eye problems
- Parasitic worm infections
- Asthma
- Pregnancy or pregnancy plans
- Breastfeeding or breastfeeding plans
The prescribing healthcare provider should also know about every drug being taken: prescription medications, over-the-counter drugs, and even supplements. For Dupixent, make sure the prescribing healthcare provider knows about any upcoming vaccines.
2. Take Dupixent as directed
Take Dupixent as directed by a healthcare provider and as written on the prescription. Do not take extra doses, do not skip doses, keep to the dosing schedule, and do not stop this medication except under the medical advice of a healthcare professional.
3. Taking a missed dose will depend on the dosing frequency
To realize the maximum benefits of Dupixent, do not miss doses. Unfortunately, it’s easy to miss doses when they’re scheduled every two to four weeks. If a Dupixent dose is missed, the rules for taking that missed dose are somewhat complex and depend on whether Dupixent is being taken every two weeks or every four weeks. Make sure you understand these rules. Better yet, don’t miss doses. Use a calendar, calendar alarm, or smartphone app to signal when a dose is due.
4. Follow the instructions given in the injection demonstration
A healthcare professional will demonstrate how to give an injection using either a prefilled syringe or pen injector. Make sure these instructions are fully understood. If not, don’t leave the demonstration until your questions are answered. Slowly and carefully reread the illustrated instructions for use before giving each injection. You’ll find these instructions packaged with the medicine.
5. Perform a safety check before administering an injection
Always check to make sure that the medicine is correct, the expiration date has not passed, and the pen injector or prefilled syringe is not damaged. Check the medicine to make sure that it is clear and either colorless or pale yellow. Do not use Dupixent if the expiration date has passed, the syringe or pen is damaged, or the medicine is discolored, cloudy, or has particles floating around in it.
6. Use different injection sites
Dupixent is usually injected once every two weeks in the upper arms, abdomen, or thighs. To avoid injection site reactions, switch out the area where injections are given. Try to use a different part of the skin in each area. Never inject the medicine into skin that is hard, tender, bruised, or injured in any way.
7. Let Dupixent warm to room temperature before an injection
Dupixent is stored in a refrigerator. Injecting cold medicine is painful, so remove the Dupixent pen injector or prefilled syringe from the refrigerator about 45 minutes before injection. Let it warm to room temperature away from sunlight. Don’t apply heat to it, microwave it, or lay it in the sun. That destroys the medicine. Just let the room’s temperature do the job.
8. Do not let children or teens self-inject Dupixent
Although Dupixent can be self-injected, caregivers should always give the injection to children and adolescents to maximize both safety and effectiveness.
9. Watch for signs of eye problems
The most common adverse effects of Dupixent are eye problems. Even though they may seem trivial at first, they may become more serious. Contact a healthcare provider if any eye problems are experienced such as dry eye, eye pain, or vision changes.
10. Watch for signs of an allergic reaction
Hypersensitivity reactions, though rare, are potentially serious. Call a healthcare provider or seek emergency medical care if you notice signs of an allergic reaction such as breathing problems, skin rash, swollen lymph nodes, hives, itching, joint pain, or swelling of the face, throat, or mouth.
Sources
- Assessing and reporting the clinical immunogenicity of therapeutic proteins and peptides—harmonized terminology and tactical recommendations, The AAPS Journal
- Dupilumab-associated ocular surface disease: presentation, management, and long-term sequelae, Eye
- Conjunctivitis occurring in atopic dermatitis patients treated with dupilumab–clinical characteristics and treatment, The Journal of Allergy and Clinical Immunology
- Dupilumab drug summary, Prescriber’s Digital Reference
- Dupixent, Epocrates
- Dupixent prescribing information, U.S. National Library of Medicine
- Dupixent website, Sanofi and Regeneron Pharmaceuticals
- Keratitis, StatPearls
- Ocular surface diseases induced by dupilumab in severe atopic dermatitis, Ophthalmology and Therapy