Dupixent Pre-filled Pen

Dupixent Pre-filled Pen is used alone or with topical steroids to treat moderate-to-severe eczema (atopic dermatitis) in adults and children who are at least 6 months old. This medicine is used when other topical treatments did not work or stopped working.

Dupixent Pre-filled Pen is also used with other medications for the long-term treatment of moderate-to-severe asthma in adults and children who are at least 6 years old.

Dupixent Pre-filled Pen is also used in adults with other medicines for the long-term treatment of chronic obstructive pulmonary disease (COPD) that is not controlled by other medicines.

Dupixent Pre-filled Pen is not a rescue medicine for treating breathing problems that get worse quickly.

Dupixent Pre-filled Pen is also used with other medicines for the long-term treatment of chronic rhinosinusitis with nasal polyposis (long-term sinus inflammation) that is not controlled by other medicines in adults and children who are at least 12 years old.

Dupixent Pre-filled Pen is also used to treat eosinophilic esophagitis in adults and children who are at least 1 year old and weigh at least 33 pounds (15 kilograms).

Dupixent Pre-filled Pen is also used to treat prurigo nodularis in adults.

Dupixent Pre-filled Pen is also used to treat chronic spontaneous urticaria that is not controlled by allergy medicine in adults and children who are at least 12 years old.

The prefilled pen is for use in adults and children who are at least 2 years old. The prefilled syringe is for use in adults and children who are at least 6 months old.

Dupixent Pre-filled Pen may also be used for purposes not listed in this medication guide.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use Dupixent Pre-filled Pen if you are allergic to it.

Tell your doctor if you have or have ever had:

• eye problems;
• infection caused by helminthic parasites; or
• if you are scheduled to receive a vaccine.

While you are using Dupixent Pre-filled Pen, you may also have an increased risk of becoming infected with parasites (helminths). Talk with your doctor about what to look out for and how to treat this condition.

Make sure you are current on all vaccines before you start using Dupixent Pre-filled Pen.

Do not allow a young child to use Dupixent Pre-filled Pen without help from an adult.

It is not known if Dupixent Pre-filled Pen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dupilumab on the baby.

Ask a doctor if it is safe to breastfeed while using Dupixent Pre-filled Pen.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Dupixent Pre-filled Pen may cause serious side effects. Call your doctor right away if you have:

• new or worsening breathing problems;
• fast heartbeat, swollen glands, itching, nausea or vomiting, stomach cramps;
• eye pain, or changes in your vision such as blurred vision;
• new or worsening joint symptoms—joint pain, trouble walking, loss of balance or coordination;
• blood vessel inflammation—fever, headache, new or worsening cough, numbness, trouble breathing, night sweats, stomach pain, weight loss, skin rash, severe tingling, body or chest pain, feeling weak or tired; or
• psoriasis symptoms—itchy or scaly skin rash.

Common side effects of Dupixent Pre-filled Pen may include:

• pain, bruising, swelling, or irritation at the injection site;
• high count of a certain type of white blood cells (eosinophilia);
• redness, swelling, or irritation of your eyes or eyelids, blurred vision;
• stomach pain, nausea, vomiting, diarrhea;
• tooth pain;
• dry eyes;
• dizziness, sleep problems (insomnia), headache;
• cold symptoms such as runny or stuffy nose, sneezing, sore throat;
• joint or muscle pain, back pain;
• cold sores in or around your mouth and lips;
• skin sores or blisters, itching, tingling, burning pain in your thigh or lower back; or
• pain and burning when you urinate.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Dupixent Pre-filled Pen is injected under the skin in the stomach, thigh, or upper arm. Your doctor will determine your treatment schedule.

A healthcare provider may teach you how to properly use the medication by yourself. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Prepare an injection only when you are ready to give it. Leave the needle cap on until you are ready to inject your dose. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Do not inject within 2 inches of your navel (belly button), or areas where the skin is hard, tender, bruised, or has scars. Do not inject into the same place two times in a row.

Doses are based on weight. Your dose may change if you gain or lose weight.

Throw away a prefilled syringe or pen after one use, even if there is still medicine left inside. Do not reuse a needle, syringe or pen. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

If you also use a steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

You may need frequent vision exams.

Store this medicine in the original container in the refrigerator. Protect from light and do not freeze or shake the medicine.

Take the medicine out of the refrigerator and let it reach room temperature for 30 to 45 minutes before injecting your dose. Do not heat a syringe or pen with hot water, sunlight, or a microwave.

You may store this medicine at room temperature for up to 14 days. Throw the medicine away if not used within 14 days. Do not put it back into the refrigerator.

For a once a week schedule: take the missed dose as soon as you can and begin a new weekly schedule on the day you remember to use it.

If you use Dupixent Pre-filled Pen every other week: take the medicine as soon as you remember and continue with your original schedule, but skip the missed dose and take your next dose at the regular time if you are 7 days late or more for the dose.

If you use Dupixent Pre-filled Pen every 4 weeks: take the medicine as soon as you remember and continue with your original schedule, but start a new every 4 week schedule on the day you remember if you are 7 days late or more for the dose.

Do not use two doses at one time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while you are being treated or right before starting treatment with Dupixent Pre-filled Pen. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others.

Tell your doctor about all your other medicines, especially:

• an oral, inhaled, or topical steroid medicine; or
• any medicine to treat asthma.

This list is not complete. Other drugs may affect Dupixent Pre-filled Pen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Find detailed information on biosimilars for this medication.