Dupilumab (doo-PIL-ue-mab)

Treats atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis.

Brand Name(s):

Dupixent PFS, Dupixent Pen

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the thigh, upper arm, or stomach area.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are tender, damaged, bruised, or scarred.
• This medicine is available as a prefilled pen or syringe.
• Allow the medicine to warm to room temperature for 30 or 45 minutes before using it.
• Check the liquid in the prefilled pen or syringe. It should be clear and colorless to pale yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not shake.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  • Every week dose schedule: If you miss a dose, use a dose as soon as possible and start a new schedule from the last dose.
  • Every other week dose schedule: If you miss a dose and it is within 7 days from the missed dose, use a dose as soon as possible and go back to your regular dosing schedule. If you miss a dose and it is more than 7 days, skip the missed dose and go back to your regular schedule.
  • Every 4 weeks dose schedule: If you miss a dose and it is within 7 days from the missed dose, use a dose as soon as possible and go back to your regular dosing schedule. If you miss a dose and it is more than 7 days, use a dose and start a new schedule based on this date.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Protect the medicine from light. Keep your medicine and supplies in the original packages until you are ready to use them. You may also keep it at room temperature for up to 14 days. Use the medicine within 14 days after removing it from the refrigerator.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• If you are using a steroid medicine for your asthma, do not suddenly stop taking it without first checking with your doctor. You may need to slowly decrease your dose before stopping it completely.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have eye or vision problems, lung or breathing problems, heart problems, or a parasite infection.
• This medicine may cause the following problems:
  • Increased risk for eye infections, including conjunctivitis or keratitis
  • Joint pain
  • Eosinophilia, including pneumonia or vasculitis (swelling of the blood vessels)
• This medicine will not stop an asthma attack that has already started. Your doctor may prescribe another medicine for you to use in case of an asthma attack. Tell your doctor right away if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, redness, swelling, numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Burning, dry, or itching eyes, discharge, excessive tearing
• Cold sores or blisters on lips, nose, eyes, or genitals
• Fast heartbeat, trouble breathing, chest pain
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Joint or muscle pain
• Redness, pain, or swelling of the eye, eyelid, or inner lining of eyelid
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, stomach upset
• Dizziness
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given
• Toothache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088