What is dupilumab?
Dupilumab (Dupixent) is a biological medication called a monoclonal antibody that is used to treat atopic diseases.
Dupilumab helps treat atopic diseases by stopping the inflammation linked to these diseases.
Dupilumab works by binding to a protein in your body called interleukin-4 receptor alpha (IL-4Rɑ), which makes it an IL-4Rɑ antagonoist. This blocks the action of two proteins called interleukin-4 (IL-4) and interleukin-13 (IL-13), which are involved in signaling the body to release substances that cause inflammation. It helps to stop inflammation before it even begins.
Dupilumab was approved by the US Food and Drug Administration (FDA) in 2017. The FDA has not approved any biosimilars of dupilumab which are drugs that have the same effect on a person, but which are only highly similar and not identical.
What is dupilumab used for?
Dupilumab is a prescription medicine used:
- to treat adults and children 6 months of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. Dupilumab can be used with or without topical corticosteroids.
- with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. Dupilumab helps prevent severe asthma attacks (exacerbations) and can improve your breathing. Dupilumab may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. Dupilumab is not used to treat sudden breathing problems.
- with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled.
- to treat adults and children 12 years of age and older, who weigh at least 88 pounds (40 kg), with eosinophilic esophagitis (EoE).
It is not known if dupilumab is safe and effective in children with:
- atopic dermatitis under 6 months of age.
- asthma under 6 years of age.
- chronic rhinosinusitis with nasal polyposis under 18 years of age
- eosinophilic esophagitis under 12 years of age and who weigh at least 88 pounds (40 kg).
Who should not use dupilumab?
Do not use dupilumab if you are allergic to dupilumab or to any of the ingredients in dupilumab. See below for a complete list of ingredients in dupilumab.
What should I tell my doctor before using dupilumab?
Before using dupilumab, tell your healthcare provider about all your medical conditions, including if you:
- have eye problems
- have a parasitic (helminth) infection
- are scheduled to receive any vaccinations. You should not receive a "live vaccine" right before and during treatment with dupilumab.
How should I use dupilumab?
- See the detailed "Instructions for Use" that comes with dupilumab for information on how to prepare and inject dupilumab and how to properly store and throw away (dispose of) used dupilumab pre-filled syringes and pre-filled pens.
- Use dupilumab exactly as prescribed by your healthcare provider.
- Your healthcare provider will tell you how much dupilumab to inject and how often to inject it.
- Dupilumab comes as a single-dose pre-filled syringe with needle shield or as a pre-filled pen.
- The dupilumab pre-filled pen is only for use in adults and children 12 years of age and older.
- The dupilumab pre-filled syringe is for use in adults and children 6 months of age and older.
- Dupilumab is given as an injection under the skin (subcutaneous injection).
- If your healthcare provider decides that you or a caregiver can give the injections of dupilumab, you or your caregiver should receive training on the right way to prepare and inject dupilumab. Do not try to inject dupilumab until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that dupilumab be given by or under the supervision of an adult. In children younger than 12 years of age, dupilumab should be given by a caregiver.
- Your healthcare provider may prescribe other medicines to use with dupilumab. Use the other prescribed medicines exactly as your healthcare provider tells you to.
What happens if I miss a dose?
If your dose schedule is every week and you miss a dose of dupilumab: Give the dupilumab injection as soon as possible and start a new every week dose schedule from the time you remember to take your dupilumab injection.
If your dose schedule is every other week and you miss a dose of dupilumab: Give the dupilumab injection within 7 days from the missed dose, then continue with your original schedule. If the missed dose is not given within 7 days, wait until the next scheduled dose to give your dupilumab injection.
If your dose schedule is every 4 weeks and you miss a dose of dupilumab: Give the dupilumab injection within 7 days from the missed dose, then continue with your original schedule. If the missed dose is not given within 7 days, start a new every 4 week dose schedule from the time you remember to take your dupilumab injection.
What happens if I overdose?
If you inject too much dupilumab (overdose), get medical help or contact a Poison Center expert right away at 1-800-222-1222.
- Atopic Dermatitis
- Adults: The recommended dose of dupilumab is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week.
- Pediatric patients 6 months to 5 years of age:
Body weight Initial and subsequent dose 5 to less than 15 kg 200 mg (one 200 mg injection) every 4 weeks 15 to less than 30 kg 300 mg (one 300 mg injection) every 4 weeks
- Pediatric patients 6 years to 17 years of age:
Body weight Initial loading dose Subsequent doses 15 to less than 30 kg 600 mg (two 300 mg injections) 300 mg every 4 weeks 30 to less than 60 kg 400 mg (two 200 mg injections) 200 mg every other week 60 kg or more 600 mg (two 300 mg injections) 300 mg every other week
- Dosage in adult and pediatric patients 12 years and older
Initial loading dose Subsequent doses 400 mg (two 200 mg injections) 200 mg every 2 weeks Or 600 mg (two 300 mg injections) 300 mg every 2 weeks
Dosage for patients with oral corticosteroid-dependent asthma or with co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid chronic rhinosinusitis with nasal polyposis
Initial loading dose Subsequent doses 600 mg (two 300 mg injections) 300 mg every 2 weeks
Dosage in pediatric patients 6 year to 11 years of age
Body weight Initial dose and subsequent doses 15 to less than 30 kg 100 mg every other week
300 mg every four weeks
≥30 kg 200 mg every other week
For pediatric patients 6 to 11 years old with asthma and co-morbid moderate-to-severe atopic dermatitis follow the dosing instructions listed above for pediatric patients with atopic dermatitis
- Dosage in adult and pediatric patients 12 years and older
- Chronic Rhinosinusitis with Nasal Polyposis
- Recommended dosage for adult patients is 300 mg given every other week.
- Eosinophilic esophagitis
- Recommended dosage for adult and pediatric patients 12 years of age and older, weighing at least 40 kg, is 300 mg given every week.
What are the side effects of dupilumab?
Serious side effects of dupilumab include:
- Allergic reactions. Dupilumab can cause allergic reactions that can sometimes be severe. Stop using dupilumab and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms:
- breathing problems or wheezing
- fast pulse
- general ill feeling
- swollen lymph nodes
- swelling of the face, lips, mouth, tongue, or throat
- nausea or vomiting
- fainting, dizziness, feeling lightheaded
- joint pain
- skin rash
- cramps in your stomach-area
- Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an eye exam if needed.
- Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive dupilumab. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by dupilumab. Tell your healthcare provider right away if you have:
- worsening shortness of breath
- persistent fever
- chest pain
- a feeling of pins and needles or numbness of your arms or legs
- Joint aches and pain. Joint aches and pain can happen in people who use dupilumab. Some people have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop dupilumab if you develop joint symptoms.
The most common side effects of dupilumab include:
- injection site reactions
- eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision
- pain in the throat (oropharyngeal pain)
- cold sores in your mouth or on your lips
- high count of a certain white blood cell (eosinophilia)
- trouble sleeping (insomnia)
- joint pain (arthralgia)
- parasitic (helminth) infections
The following additional side effects have been reported with dupilumab:
- facial rash or redness
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of dupilumab.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you:
- are taking oral, topical, or inhaled corticosteroid medicines
- have asthma and use an asthma medicine
- have atopic dermatitis or CRSwNP, and also have asthma
Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to come back.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether dupilumab will harm your unborn baby.
There is a pregnancy exposure registry for women who take dupilumab during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-877-311-8972 or going to https://mothertobaby.org/ongoing-study/dupixent/.
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether dupilumab passes into your breast milk.
- Dupilimab is sterile and preservative-free. Discard any unused portion.
- Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
- If necessary, dupilimab may be kept at room temperature up to 25°C (77°F) for a maximum of 14 days. Do not store above 25°C (77°F). After removal from the refrigerator, dupilumab. must be used within 14 days or discarded.
- Do not expose dupilumab to heat or direct sunlight.
- Do not freeze.
- Do not shake.
What are the ingredients in dupilumab?
Active ingredient: dupilumab
Inactive ingredients: L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection.
Dupilumab is manufactured by Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591. Dupilumab is marketed under the brandname Dupixent by Regeneron Pharmceuticals and Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807.
Dupixent can start to work in 2 to 4 weeks to relieve your symptoms of moderate-to-severe eczema, asthma, or chronic rhinosinusitis with nasal polyps. In studies of eosinophilic esophagitis, improved inflammation and swallowing was seen in 24 weeks. For adults with prurigo nodularis, improved itching was seen at 12 and 24 weeks, and reduced skin lesions (clear or almost clear skin) at 24 weeks. Continue reading
Dupixent (generic name: dupilumab) is given as a subcutaneous (under the skin) injection into the upper thigh or stomach area by the patient or a caregiver. Your doctor will tell you how often to inject Dupixent. Continue reading
Dupixent is approved by the FDA for four different uses, for use in: moderate-to-severe eczema (atopic dermatitis), in moderate-to-severe asthma, in adults with nasal polyps (growths on the sinuses) accompanied by chronic rhinosinusitis (sinus and nasal cavity swelling), for eosinophilic esophagitis (EoE), and prurigo nodularis in adults. Dupixent works by lowering inflammation (swelling) that can lead to symptoms in these conditions. Continue reading
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