Dupilumab, known by its brand name Dupixent, is a prescription monoclonal antibody, which is a lab-created protein that targets specific parts of the immune system. This article clarifies the official U.S. Food and Drug Administration (FDA) package insert. It explains the medication’s approved uses, administration, and potential risks in a straightforward manner.
Approved Medical Uses
The FDA has approved dupilumab for several conditions driven by a specific type of inflammation, as the medication works by blocking two proteins involved in these inflammatory processes. Approved uses include:
- Moderate-to-severe atopic dermatitis (eczema) in adults and children as young as six months old that is not well managed by topical treatments. It can be used alone or with topical corticosteroids.
- Add-on maintenance treatment for moderate-to-severe asthma in patients aged six years and older with an eosinophilic phenotype or who are dependent on oral corticosteroids.
- Chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled with other medicines.
- Eosinophilic esophagitis (EoE) in adults and children aged one year and older who weigh at least 33 pounds (15 kg).
- Prurigo nodularis (PN) in adults, a skin condition characterized by hard, itchy nodules.
Administration and Dosing Guidelines
Dupilumab is administered as a subcutaneous injection into the fatty tissue under the skin. Patients are shown how to perform the injections by a healthcare provider before doing it themselves at home. Injection sites should be rotated between the thighs, the abdomen (avoiding the two inches around the navel), and the upper arm. The medication must be stored in a refrigerator between 36°F and 46°F (2°C to 8°C) and protected from light.
The dosing schedule varies by condition. For atopic dermatitis in adults and adolescents, treatment begins with a 600 mg loading dose, followed by 300 mg every other week. For asthma, the initial dose is 400 mg, followed by 200 mg every other week. The recommended dosage for chronic rhinosinusitis with nasal polyposis is 300 mg every other week, and for eosinophilic esophagitis, it is 300 mg weekly for patients over 40 kg. Pediatric dosages may be adjusted based on weight.
Risks and Side Effects
Patients should be aware of potential risks associated with dupilumab. Hypersensitivity reactions, including the severe allergic reaction anaphylaxis, can occur. These may present as hives, rash, trouble breathing, or swelling of the face, lips, mouth, or tongue. If a patient experiences symptoms of a serious allergic reaction, they should stop the injection and seek immediate medical help.
Eye-related issues, specifically conjunctivitis and keratitis, have been reported. Symptoms to watch for include eye pain, redness, itching, and changes in vision, and can range from mild irritation to more significant discomfort. Patients should report any new or worsening eye problems to their healthcare provider, who may recommend an ophthalmologic exam.
The medication can increase eosinophils, a type of white blood cell, which is often an expected effect of the drug’s mechanism. In rare cases, patients being treated for asthma may develop a serious condition where eosinophils cause inflammation in various parts of the body. Patients should report symptoms like worsening rash, chest pain, or shortness of breath. Arthralgia, or joint pain, has also been reported, and any new or worsening joint pain should be discussed with a doctor.
Before starting treatment, inform your doctor if you have a parasitic (helminth) infection, as dupilumab may weaken the body’s ability to fight it off. Any existing infection should be treated before therapy begins. Patients should also avoid receiving live vaccines while on dupilumab, as the interaction has not been studied, and it is advised to complete any necessary live vaccinations before starting the treatment.
The most frequent side effects are injection site reactions, which can include pain, redness, swelling, and itching. These reactions are mild to moderate in severity and tend to decrease in frequency over time. Other reported side effects include oral herpes, which can manifest as cold sores.
Use in Specific Patient Groups
The use of dupilumab has been considered for several specific patient populations. For individuals who are pregnant, a pregnancy exposure registry monitors the health outcomes of those exposed to the medication. This registry collects data to better understand the drug’s safety during pregnancy, as human data is limited.
Regarding lactation, it is not known if dupilumab passes into human breast milk or what effects it might have on a breastfed infant. Patients should discuss the potential benefits and risks with their healthcare provider to make an informed decision.
Dupilumab is approved for pediatric use in specific age groups depending on the condition. In geriatric patients, clinical studies did not show a significant difference in safety or effectiveness compared to younger adults, though the number of older participants was limited.