dupilumab

What is the most important information I should know about dupilumab?

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What is dupilumab?

Dupilumab is used in adults and children 6 months and older to treat moderate-to-severe eczema (atopic dermatitis) that cannot be controlled with topical medicines applied to the skin.

Dupilumab is also used in adults and children 6 years and older together with other medications to treat moderate-to-severe asthma that is not controlled with other asthma medicines.

Dupilumab is used only in adults to treat a condition called chronic rhinosinusitis (long-term sinus inflammation) that is associated with nasal polyps.

Dupilumab is used to treat eosinophilic esophagitis in adults and children 12 years and older, weighing at least 88 pounds (40 kilograms).

Dupilumab is also used to treat prurigo nodularis in adults.

Dupilumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using dupilumab?

Tell your doctor if you have ever had:

• eye problems;
• a parasite infection (such as roundworms or tapeworms); or
• if you are scheduled to receive any vaccine.

If you use dupilumab to treat eczema or chronic rhinosinusitis with nasal polyposis, tell your doctor if you also have asthma.

Tell your doctor if you are pregnant or breastfeeding.

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

How should I use dupilumab?

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

Dupilumab is injected under the skin, usually once every 2 to 4 weeks. Your first dose may be given in 2 injections.

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 don't understand all instructions.

Do not shake the prefilled syringe or injection pen. Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Take a syringe or pen out of the refrigerator and let it reach room temperature for 30 to 45 minutes before injecting your dose. Leave the needle cap on until you are ready to inject your dose.

Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.

The pre-filled pen is for use in adults and children 12 years and older. The pre-filled syringe is for use in adults and children 6 months and older.

Use a needle and syringe or pen only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

If you also use other medications to treat eczema or asthma, do not change your doses or stop using the other medications without your doctor's advice.

What happens if I miss a dose?

If you miss your injection by 7 days or less, use the missed dose as soon as you remember and then go back to your regular injection schedule.

If you are more than 7 days late for the injection:

• For the every-other-week injection schedule: Skip the missed dose and use the medicine at your next scheduled injection time.
• For the every-4-weeks schedule: Start a new dosing schedule on the day you use the missed injection and use your next injection 4 weeks later.

Do not use two doses at one time.

What happens if I overdose?

What should I avoid while using dupilumab?

Do not receive a "live" vaccine while using dupilumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of dupilumab?

• new or worsening eye pain or discomfort;
• vision changes;
• watery eyes (your eyes may be more sensitive to light);
• fast pulse;
• stomach cramps;
• feeling like something is in your eye; or
• blood vessel inflammation --fever, chest pain, trouble breathing, skin rash, numbness or prickly feeling in your arms or legs.

Common side effects may include:

• pain, swelling, burning, or irritation where an injection was given;
• blood vessel inflammation;
• eye redness or itching, puffy eyelids;
• stomach pain, nausea, vomiting, diarrhea;
• sore throat;
• tooth pain;
• sleep problems (insomnia);
• cold symptoms such as stuffy nose, sneezing, sore throat;
• skin sores or blisters, itching, tingling, burning pain in your thigh or lower back;
• joint or muscle pain; or
• cold sores or fever blisters on your lips or in your mouth.

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 FDA at 1-800-FDA-1088.

What other drugs will affect dupilumab?

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 dupilumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about dupilumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 6.02. Revision date: 12/27/2022.