Uses

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. 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 asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

How To Use

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. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under your 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. For children, the dosage may also be based on their weight.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Wash your hands before using this medication. Before use, remove the medication from the refrigerator and let it warm up to room temperature (at least 30 or 45 minutes, depending on your dose). Do not warm up this medication any other way such as by heating in the microwave, placing in hot water, or leaving it in direct sunlight. Do not shake the medication. The medication should be clear or slightly yellow. Before using, check this product visually for cloudiness, particles, or discoloration. If you see any of these things, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject through clothes. 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. Do not reuse syringes.

Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.

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

Side Effects

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.

Precautions

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 breast-feeding.

Drug Interactions

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.

Overdose

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 their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed Dose

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.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store this medication in the refrigerator. Do not freeze. Keep the product in the original carton to protect from light. This medication may also be stored at room temperature for up to 14 days. If stored at room temperature, use or discard after 14 days.

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.

Medical Alert

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).