Pronunciation:

doo-PIL-ue-mab

Brand Names:

• Dupixent

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Dermatological Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Dupilumab injection is used alone or in combination with other medicines (eg, topical corticosteroids) to treat moderate to severe atopic dermatitis in patients who have been treated with topical medicines that did not work well or who cannot use topical treatment.

Dupilumab injection is also used together with other medicines to treat moderate to severe asthma in patients whose asthma is hard to control or who are dependent on steroid medicines. Dupilumab helps prevent severe asthma attacks (exacerbations) and can improve your breathing. This medicine will not relieve an asthma attack that has already started.

Dupilumab injection is also used as additional treatment for poorly controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). This medicine is also used to treat eosinophilic esophagitis (EoE) and prurigo nodularis (PN).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of dupilumab injection to treat atopic dermatitis in children younger than 6 months of age, to treat asthma in children younger than 6 years of age, to treat eosinophilic esophagitis in children younger than 12 years of age and weighing less than 40 kilograms (kg), or to treat chronic rhinosinusitis with nasal polyposis or prurigo nodularis in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dupilumab injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack or
• Bronchospasm (breathing problem) or
• Status asthmaticus (severe asthma attack)—Should not be used in patients with these conditions.

• Conjunctivitis (pink eye) or
• Heart problems or
• Keratitis (inflammation of the cornea of the eye)—Use with caution. May make these conditions worse.

• Parasitic infection—Use with caution. It is not known if this medicine may affect patients with this condition. Treat the infection first before using this medicine.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the thigh, stomach area, or upper arm. This medicine may also be given at home to patients who do not need to be in a hospital or clinic. You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine.

This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you use Dupixent® at home, 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. This will help prevent skin problems. Do not inject into skin areas that are tender, damaged, bruised, or scarred.

This medicine is available as a prefilled pen or syringe. Use the prefilled pen only for adults and children 2 years of age and older. Use the prefilled syringe only for adults and children 6 months of age and older.

Dupixent® should be given by or under the supervision of an adult in children 12 years of age and older. This medicine should be given by a caregiver in children 6 months to less than 12 years of age.

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.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled pen or syringe):
  • For asthma dependent on steroids or asthma with atopic dermatitis:
    • Adults and children 12 years of age and older—At first, 600 milligrams (mg) (two 300 mg injections) injected under the skin at different injection sites. Then, your dose will be reduced to 300 mg every other week.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For chronic rhinosinusitis with nasal polyposis:
    • Adults—300 milligrams (mg) injected under the skin every other week.
    • Children—Use and dose must be determined by your doctor.
  • For eosinophilic esophagitis:
    • Adults and children 12 years of age and older weighing at least 40 kilograms (kg)—300 milligrams (mg) injected under the skin every week.
    • Children younger than 12 years of age weighing less than 40 kg—Use and dose must be determined by your doctor.
  • For moderate to severe asthma:
    • Adults and children 12 years of age and older—At first, 400 or 600 milligrams (mg) (two 200 or 300 mg injections) injected under the skin at different injection sites. Then, your dose will be reduced to 200 or 300 mg every other week.
    • Children 6 to 11 years of age—Dose is based on body weight and must be determined by your doctor.
      • Weighing 30 kilograms (kg) or more—200 mg injected under the skin every other week.
      • Weighing 15 kg to less than 30 kg—100 mg injected under the skin every other week or 300 mg injected under the skin every 4 weeks.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For moderate to severe atopic dermatitis:
    • Adults—At first, 600 milligrams (mg) (two 300 mg injections) injected under the skin at different injection sites. Then, your dose will be reduced to 300 mg every other week.
    • Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor.
      • Weighing 60 kilograms (kg) or more—At first, 600 mg (two 300 mg injections) injected under the skin at different injection sites. Then, your dose will be reduced to 300 mg every other week.
      • Weighing 30 kg to less than 60 kg—At first, 400 mg (two 200 mg injections) injected under the skin at different injection sites. Then, your dose will be reduced to 200 mg every other week.
      • Weighing 15 kg to less than 30 kg—At first, 600 mg (two 300 mg injections) injected under the skin at different injection sites. Then, your dose will be reduced to 300 mg every 4 weeks.
    • Children 6 months to 5 years of age—Dose is based on body weight and must be determined by your doctor.
      • Weighing 15 kg to less than 30 kg—300 mg injected under the skin at different injection sites every 4 weeks.
      • Weighing 5 kg to less than 15 kg—200 mg injected under the skin at different injection sites every 4 weeks.
    • Children younger than 6 months of age—Use and dose must be determined by your doctor.
  • For prurigo nodularis:
    • Adults—At first, 600 milligrams (mg) (two 300 mg injections) injected under the skin at different injection sites. Then, your dose will be reduced to 300 mg every other week.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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, skip the missed dose and start a new schedule based on this date.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect the medicine from direct light. Keep the medicine in the original package until you are ready to use it. You may also store the prefilled syringe or pen 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.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, generalized urticaria, angioedema, or serum sickness, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a feeling of discomfort, fever, pain or swelling of the joints, hives, itching, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, lightheadedness, dizziness, fainting, muscle aches, rash, swollen lymph glands, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Check with your doctor right away if you have redness, irritation, or itching the of eye, eyelid, or inner lining of the eyelid. These could be symptoms of eye problems, including conjunctivitis or keratitis.

A rare but serious condition called eosinophilia (increased white blood cells in the body) may occur while you are using this medicine. Pneumonia or a condition called vasculitis (inflammation of the blood vessels) may also be present. Eosinophilia can be serious and requires immediate medical attention. Tell your doctor right away if you or your child have worsening lung symptoms, rash or bruising of the skin, fever, chest pain, or burning, tingling, or numbness in the hands and feet after using this medicine.

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.

Check with your doctor right away if you have difficulty in moving, joint pain, or muscle pain or stiffness.

Do not have any live vaccines (immunizations) while you are being treated with dupilumab. Check with your doctor before having any vaccines.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet

body aches or pain

burning or dry eyes

chills

cough

difficulty in breathing

ear congestion

excessive tearing

fever

headache

loss of voice

muscle aches

numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet

pain, redness, irritation, itching, or swelling of the eye, eyelid, or inner lining of the eyelid

sneezing

sore throat

stuffy or runny nose

unusual tiredness or weakness

Less common

Black, tarry stools

blistering, crusting, or reddening of the skin

bone, joint, or muscle pain

burning, tingling, or numbness in the hands and feet

burning or stinging of the skin

chest pain

difficulty in moving

lump or growth on the skin

muscle cramps or stiffness

painful cold sores or blisters on the lips, nose, eyes, or genitals

painful or difficult urination

scaly patches on the skin

skin rash

sores or white patches on the lips, mouth, or throat

swollen glands

swollen joints

unusual bleeding or bruising

Rare

Feeling of discomfort

hives, itching

lightheadedness, dizziness, fainting

pain in the groin or legs, especially the calves

pain or swelling in the joints

severe, sudden headache

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

swelling of the hands, face, or mouth

trouble breathing

trouble swallowing

vision changes

Incidence not known

Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Less common

Burning feeling in the chest or stomach

diarrhea

indigestion

mouth or throat pain

stomach upset

tenderness in the stomach area

toothache

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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