Dupilumab Injection

WHY is this medicine prescribed?

Dupilumab injection is used for the following:

• to treat eczema (atopic dermatitis; a skin disease that causes dry, itchy skin and red, scaly rashes)
• to treat asthma (chronic inflammatory condition of the airways in the lungs causing them to narrow and swell)
• to treat chronic rhinosinusitis with nasal polyps (a chronic inflammation of nasal cavity and sinuses with polyps, noncancerous growths)
• to treat eosinophilic esophagitis (EoE; a condition when blood cells build up in and damage the esophagus [tube that connects the mouth to the stomach])
• to treat prurigo nodularis (a skin condition that causes crusty lumps on the skin and severe itching)
• to treat certain types of chronic obstructive pulmonary disease (COPD; progressive ling disease that results in airflow obstruction and breathing difficulties)
• to treat chronic spontaneous urticaria (CSU; a skin disease where hives appear and stay for longer than 6 weeks without a known trigger)
• to treat bullous pemphigoid (a condition in which the body attacks its own skin causing blisters on the arms, legs, body, and mouth)

Dupilumab injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain substances in the body that cause inflammation.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Dupilumab injection comes as a prefilled syringe and a prefilled pen to inject subcutaneously (under the skin). Your doctor will tell you how often to use dupilumab injection based on your condition, age, and weight (for children).

Use dupilumab injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

Continue to take or use all other medications that your doctor has prescribed to treat your condition. Do not stop taking any of your medications or change the doses of any of your medications unless your doctor tells you that you should.

You may receive your first dose of dupilumab injection in your doctor's office. After that, you may be allowed to be given the injections at home. Make sure you read the patient information. Ask your doctor or pharmacist to show you or your caregiver how to inject it.

Use each syringe and pen only once. Dispose used syringes and pens in a puncture-resistant container. Ask your doctor or pharmacist about disposal of the puncture-resistant container.

If you are using dupilumab injection that has been refrigerated, place it on a flat surface and allow it warm to room temperature before you inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method. Ask your doctor or pharmacist if you have anyquestions about how long it will take to warm a syringe or pen to room temperature.

Do not remove the cap from the prefilled syringe or pen until you are ready to inject dupilumab. Do not replace the cap after you remove it. Do not use the syringe or penif you drop it on the floor or if it is cracked or broken.

Do not shake a syringe or pen that contains dupilumab.

Always look at dupilumab solution before injecting it. Check that the expiration date has not passed and the liquid is clear and colorless or slightly yellow. The liquid should not contain visible particles. Do not use a syringe or pen if it is expired, frozen, or if the liquid is cloudy or contains small particles.

You can inject dupilumab injection anywhere on the front of your thighs (upper leg) or stomach except your navel (belly button) and the area 2 inches (5 centimeters) around it. If a caregiver injects the medication, the back of the upper arm may also be used. To reduce the chances of soreness or redness, use a different site for each injection. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.

Dupilumab injection is not used to treat sudden breathing problems. Your doctor will prescribe a short-acting inhaler to use if sudden breathing problems occur. Talk to yourdoctor about how to treat symptoms of sudden breathing problems. If your asthma or COPD symptoms get worse or if you have breathing problems moreoften, be sure to talk to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using dupilumab injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had eye problems; herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past), genital herpes (a herpes virus infection that causes sores to form around the genitals and rectum from time to time), or any other herpes virus infection; or if you have a hookworm, roundworm, whipworm, or threadworm infection (infection with worms that live inside the body). If you are receiving dupilumab for the treatment of atropic dermatitis, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic hives, or bullous pemphigoid, tell your doctor if you also have asthma.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using dupilumab injection, call your doctor.

• check with your doctor to see if you need to receive any vaccinations. Do not have any vaccinations during your treatment without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss a dose given every 2 or 4 weeks, inject your missed dose as soon as you remember it and resume your original schedule. However, if it is more than 7 days after your missed dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

If you miss a dose given once a week, inject your missed dose as soon as you remember it and continue your treatment using a new weekly schedule from the date of the last administered dose.

Call your doctor if you miss a dose and have questions about what to do.

What SIDE EFFECTS can this medicine cause?

Dupilumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness or pain at the injection site
• sore throat, runny nose, cough, fever, or other sign of infection
• mouth or lip sores
• toothache
• difficulty falling asleep or staying asleep
• dizziness
• diarrhea
• muscle pain
• headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• new or worsening eye problems, including eye pain, blurred vision, pink or red eye(s), red or swollen eyelids, or changes in vision
• rash, shortness of breath, fever, chest pain, brown or dark colored urine, feeling of pins and needles, or numbness in arms or legs
• new or worsening joint pain
• new or worsening skin problem

If you experience any of these symptoms, stop using dupilumab injection and call your doctor immediately or get emergency medical treatment:

• swelling of the face, eyelids, tongue, or throat; swollen lymph nodes; difficulty swallowing or breathing; tightness in the chest or throat; rapid heartbeat; fainting, dizziness, or feeling lightheaded
• rash; hives; itching; or flat, firm, hot, red and painful skin lumps
• nausea or vomiting, stomach cramps, or fever

Dupilumab injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the original container it came in, tightly closed, and out of reach of children. Store dupilumab injection in the refrigerator or at room temperature for up to 14 days. Do not freeze. Keep the syringes and pens in their original cartons to protect them from light.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.