Dupilumab Injection

Dupilumab injection is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in adults and children 6 months of age and older who cannot use other medications for their condition or whose eczema has not responded to other medications. It is also used along with other medications to prevent wheezing, shortness of breath, coughing, and chest tightness due to certain types of asthma in adults and children 6 years and older whose symptoms are not controlled with other medications. Dupilumab injection is also used along with other medications to treat chronic rhinosinusitis with nasal polyposis (ongoing runny nose, sinus swelling and/or nasal congestion, with or without a reduced sense of smell or pain and pressure in the face) in adults whose symptoms are not controlled with other medications. It is also used to treat eosinophilic esophagitis (EoE; a condition that involves high levels of blood cells in the esophagus [tube that connects the mouth to the stomach] that may damage tissues of the esophagus) in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg). Dupilumab injection is also used to treat prurigo nodularis (a skin condition that causes crusty lumps on the skin and severe itching) in adults. 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.

Dupilumab injection comes as a prefilled syringe and a prefilled pen to inject subcutaneously (under the skin). For the treatment of eczema in adults, it is usually given as two injection(s) for the first dose, followed by one injection every 2 weeks. For the treatment of eczema in children 6 to 17 years of age, it is usually given as two injections for the first dose, followed by one injection every 2 or 4 weeks depending on the weight of the child; for children 6 months to 5 years of age with eczema, it is usually given every 4 weeks. For the treatment of of asthma in adults and children 12 years of age and older, it is usually given as two injection(s) for the first dose, followed by one injection every 2 weeks. For the treatment of asthma in children 6 to 11 years of age, it is usually given as one injection every 2 or 4 weeks depending on the weight of the child. For the treatment of chronic rhinosinusitis with nasal polyposis in adults, it is usually given as one injection every 2 weeks. For the treatment of eosinophilic esophagitis in adults and children 12 years of age and older, it is usually given as one injection once a week. For the treatment of prurigo nodularis, it is usually given as two injections for the first dose, followed by one injection every 2 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use dupilumab injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

If you are using dupilumab and have asthma, continue to take or use all other medications that your doctor has prescribed to treat your asthma. 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. Dupilumab injection helps to prevent asthma attacks but will not stop an asthma attack that has already started. Do not use dupilumab injection during an asthma attack. Your doctor will prescribe an inhaler to use during asthma attacks.

You may receive your first dose of dupilumab injection in your doctor's office. After that, your doctor may allow you or a caregiver to perform the injections at home. Before you use dupilumab injection yourself the first time, read the manufacturer's information for the patient that comes with the medication. Ask your doctor or pharmacist to show you or the person who will be giving the medication how to inject it.

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

If you are using a prefilled syringe or prefilled pen that has been refrigerated, place the syringe on a flat surface without removing the needle cap and allow it warm to room temperature (30 minutes for the 100 mg or 200 mg prefilled syringe and 45 minutes for the 300 mg prefilled syringe or prefilled pen) before you are ready to 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.

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 that 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 cracked or broken, if it is expired or 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 abdomen (stomach) except your navel 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.

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

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

Before using dupilumab injection,

• tell your doctor and pharmacist if you are allergic to dupilumab, any other medications, or any of the ingredients in dupilumab injection. Ask your pharmacist for a list of the ingredients.

• 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, or prurigo nodularis, 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.

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

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.

• 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

  • facial redness or rash

  • dizziness

  • diarrhea

  • muscle pain

• 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, feeling of pins and needles, or numbness in arms or legs

  • new or worsening joint pain

• 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

  • itching

  • rash

  • hives

  • fainting, dizziness, or feeling lightheaded

  • nausea or vomiting

  • stomach cramps

  • flat, firm, hot, red and painful skin lumps

  • 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.