Dupixent 300 mg/2 mL subcutaneous pen injector

Generic name:
Dupilumab - injection

Pronunciation
(doo-PIL-ue-mab)

Brand name(s)
Dupixent

This medication is used to treat certain skin conditions (eczema, prurigo nodularis) and a certain esophagus problem (eosinophilic esophagitis). It is also used along with other medications to help control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD). In addition, dupilumab may be used to reduce symptoms caused by nasal polyps and the long-term swelling of the sinuses and nasal passage (chronic rhinosinusitis with nasal polyposis). Dupilumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking certain natural proteins in your body (interleukin-4 and interleukin-13) that may cause inflammation and swelling.

This medication should not be used to relieve sudden shortness of breath or wheezing. If sudden breathing problems occur, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using dupilumab and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor. The injection is given in the upper arms, thighs, or abdomen (except for a 2-inch area around your belly button). The dosage is based on your medical condition and response to treatment. Children's dosage may also be based on weight.

Depending on your product, take the medication out of the refrigerator 30 or 45 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave, place it in hot water, or leave it in direct sunlight). Do not shake the medication. Before using, check this product for cloudiness, particles, or discoloration. If you see any of these things, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is tender, damaged, bruised or scarred. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

Redness, irritation, or pain at the injection site may occur. Swelling/redness/itching of the eyes or eyelids may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• other eye problems (such as eye pain, changes in vision)
• joint pain

Rarely, people with asthma who also use a steroid medication have had symptoms that might be due to stopping or lowering the dose of their steroid. Tell your doctor right away if you develop symptoms such as fever that doesn't go away, chest pain, or numbness/tingling in your arms or legs. Do not stop or change the dose of your steroid medication without your doctor's direction.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using dupilumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• a certain type of infection (helminth)

Tell your health care professional that you are using dupilumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

It is important to get each dose of this medication as scheduled. If your dose is given weekly and you miss a dose, use it as soon as you remember. Start your new weekly dosing schedule from that day on. If your dose is given every 2 or 4 weeks and you miss a dose, give a dose if it is less than 7 days from the missed dose. If your dose is given every 2 weeks and it is more than 7 days from the missed dose, then skip the missed dose. Use your next dose at the regular time. If your dose is given every 4 weeks and it is more than 7 days from the missed dose, then start a new dosing schedule with the first dose given right away. For any missed doses, do not double the dose to catch up.

Store in the refrigerator. Do not freeze. Keep the medication in the original carton to protect from light. This medication may also be stored at room temperature if needed. If the medication is stored at room temperature, discard after 14 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.