Dupixent Drug Facts
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DUPIXENT safely and effectively. See full prescribing information for DUPIXENT at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780&type=display.
DUPIXENT®(dupilumab) injection, for subcutaneous use Initial U.S. Approval: 2017
Patient Information DUPIXENT®(DU-pix-ent) (dupilumab)
What is DUPIXENT? DUPIXENT is a prescription medicine used: • to treat adults and children 6 years 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. DUPIXENT 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. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT 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. DUPIXENT works by blocking two proteins that contribute to a type of inflammation that plays a major role in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis or asthma under 6 years of age. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.
Do not use DUPIXENT if you are allergic to dupilumab or to any of the ingredients in DUPIXENT. See the end of this leaflet for a complete list of ingredients in DUPIXENT.
Before using DUPIXENT, 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 DUPIXENT. • are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby. Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who take DUPIXENT 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/. • are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk. 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.
How should I use DUPIXENT? See the detailed ″Instructions for Use″ that comes with DUPIXENT for information on how to prepare and inject DUPIXENT and how to properly store and throw away (dispose of) used DUPIXENT pre-filled syringes and pre-filled pens. • Use DUPIXENT exactly as prescribed by your healthcare provider. • Your healthcare provider will tell you how much DUPIXENT to inject and how often to inject it. • DUPIXENT comes as a single-dose pre-filled syringe with needle shield or as a pre-filled pen. • The DUPIXENT pre-filled pen is only for use in adults and children 12 years of age and older. • The DUPIXENT pre-filled syringe is for use in adults and children 6 years of age and older. • DUPIXENT 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 DUPIXENT, you or your caregiver should receive training on the right way to prepare and inject DUPIXENT. Do not try to inject DUPIXENT until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that DUPIXENT be given by or under the supervision of an adult. In children younger than 12 years of age, DUPIXENT should be given by a caregiver. • If your dose schedule is every other week and you miss a dose of DUPIXENT: Give the DUPIXENT 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 DUPIXENT injection. • If your dose schedule is every 4 weeks and you miss a dose of DUPIXENT: Give the DUPIXENT 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 DUPIXENT injection. • If you inject too much DUPIXENT (overdose), get medical help or contact a Poison Center expert right away at 1-800-222-1222. • Your healthcare provider may prescribe other medicines to use with DUPIXENT. Use the other prescribed medicines exactly as your healthcare provider tells you to.
What are the possible side effects of DUPIXENT? DUPIXENT can cause serious side effects, including: Allergic reactions. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT 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 • fever • general ill feeling • swollen lymph nodes • swelling of the face, lips, mouth, tongue, or throat • hives • itching • 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 DUPIXENT. 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 DUPIXENT. Tell your healthcare provider right away if you have: • rash • 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 DUPIXENT. 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 DUPIXENT if you develop joint symptoms.
The most common side effects of DUPIXENT 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) • toothache • gastritis • joint pain (arthralgia) • parasitic (helminth) infections
The following additional side effects have been reported with DUPIXENT: • 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 DUPIXENT. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of DUPIXENT. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DUPIXENT for a condition for which it was not prescribed. Do not give DUPIXENT to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about DUPIXENT that is written for health professionals.
What are the ingredients in DUPIXENT? Active ingredient: dupilumab Inactive ingredients: L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection