Usual Adult Dose for Atopic Dermatitis

Initial dose: 600 mg subcutaneously once
Subsequent doses: 300 mg subcutaneously every other week

Comments:

• The 600 mg initial dose should be administered as 2 injections (300 mg per injection) at different injection sites.
• This drug can be used with or without topical corticosteroids.
• Topical calcineurin inhibitors may be used but should be reserved for problem areas only (e.g., face, neck, intertriginous areas, genital areas).

Use: For the treatment of patients with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable

Usual Adult Dose for Sinusitis

300 mg subcutaneously every other week

Use: As an add-on maintenance treatment in patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP)

Usual Adult Dose for Asthma

Initial loading dose: 400 mg subcutaneously once
Subsequent doses: 200 mg subcutaneously every 2 weeks
OR
Initial loading dose: 600 mg subcutaneously once
Subsequent doses: 300 mg subcutaneously every 2 weeks

For patients with oral corticosteroid-dependent asthma, with comorbid moderate to severe atopic dermatitis, or with comorbid CRSwNP:

• Initial loading dose: 600 mg subcutaneously once
• Subsequent doses: 300 mg subcutaneously every 2 weeks

Comments:

• Limitations of Use: This drug is not indicated for the relief of acute bronchospasm or status asthmaticus.
• The 400 or 600 mg initial loading dose should be administered as 2 injections (200 or 300 mg per injection, respectively) at different injection sites.

Use: As an add-on maintenance treatment of patients with moderate to severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma

Usual Adult Dose for Eosinophilic Esophagitis

300 mg subcutaneously every week

Use: For the treatment of patients with eosinophilic esophagitis

Usual Adult Dose for Prurigo Nodularis

Initial dose: 600 mg subcutaneously once
Subsequent doses: 300 mg subcutaneously every other week

Comments:

• The 600 mg initial dose should be administered as 2 injections (300 mg per injection) at different injection sites.

Use For the treatment of patients with prurigo nodularis

Usual Pediatric Dose for Atopic Dermatitis

6 months to 5 years:

• Weight 5 to less than 15 kg: 200 mg subcutaneously every 4 weeks
• Weight 15 to less than 30 kg: 300 mg subcutaneously every 4 weeks

6 to 17 years:

• Weight 15 to less than 30 kg:
• Initial loading dose: 600 mg subcutaneously once
• Subsequent doses: 300 mg subcutaneously every 4 weeks
• Weight 30 to less than 60 kg:
• Initial loading dose: 400 mg subcutaneously once
• Subsequent doses: 200 mg subcutaneously every other week
• Weight at least 60 kg:
• Initial loading dose: 600 mg subcutaneously once
• Subsequent doses: 300 mg subcutaneously every other week

Comments:

• For patients 6 months to 5 years of age: No initial loading dose is recommended.
• For patients 6 to 17 years of age: The 400 or 600 mg initial loading dose should be administered as 2 injections (200 or 300 mg per injection, respectively) at different injection sites.
• This drug can be used with or without topical corticosteroids.
• Topical calcineurin inhibitors may be used but should be reserved for problem areas only (e.g., face, neck, intertriginous areas, genital areas).

Use: For the treatment of patients with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable

Usual Pediatric Dose for Asthma

6 to 11 years:

• Weight 15 to less than 30 kg: 100 mg subcutaneously every other week OR 300 mg subcutaneously every 4 weeks
• Weight at least 30 kg: 200 mg subcutaneously every other week

For patients 6 to 11 years with comorbid moderate to severe atopic dermatitis:

• Weight 15 to less than 30 kg:
• Initial loading dose: 600 mg subcutaneously once
• Subsequent doses: 300 mg subcutaneously every 4 weeks
• Weight 30 to less than 60 kg:
• Initial loading dose: 400 mg subcutaneously once
• Subsequent doses: 200 mg subcutaneously every other week
• Weight at least 60 kg:
• Initial loading dose: 600 mg subcutaneously once
• Subsequent doses: 300 mg subcutaneously every other week

12 years and older:

• Initial loading dose: 400 mg subcutaneously once
• Subsequent doses: 200 mg subcutaneously every 2 weeks

OR

• Initial loading dose: 600 mg subcutaneously once
• Subsequent doses: 300 mg subcutaneously every 2 weeks

For patients 12 years and older with oral corticosteroid-dependent asthma or with comorbid moderate to severe atopic dermatitis:

• Initial loading dose: 600 mg subcutaneously once
• Subsequent doses: 300 mg subcutaneously every 2 weeks

Comments:

• Limitations of Use: This drug is not indicated for the relief of acute bronchospasm or status asthmaticus.
• For patients 6 to 11 years of age with asthma: No initial loading dose is recommended.
• For patients 6 to 11 years of age with asthma and comorbid moderate to severe atopic dermatitis and patients 12 years and older: The 400 or 600 mg initial loading dose should be administered as 2 injections (200 or 300 mg per injection, respectively) at different injection sites.

Use: As an add-on maintenance treatment of patients with moderate to severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma

Usual Pediatric Dose for Eosinophilic Esophagitis

12 years and older weighing at least 40 kg: 300 mg subcutaneously every week

Use: For the treatment of patients with eosinophilic esophagitis

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 6 months with atopic dermatitis, younger than 6 years with asthma, or younger than 12 years and weighing less than 40 kg with eosinophilic esophagitis. Safety and efficacy have not been established in patients younger than 18 years with CRSwNP or prurigo nodularis.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Before starting this drug, consider completing all age-appropriate vaccinations as recommended by current immunization guidelines.
• Administer by subcutaneous injection.
• Administer injection into the thigh or abdomen (except for the 2 inches [5 cm] around the naval); if administered by a caregiver, the upper arm can also be used.
• Rotate the injection site with each injection; do not inject into skin that is tender, damaged, bruised, or scarred.
• Use the prefilled pen in adult and pediatric patients aged 2 years and older.
• Use the prefilled syringe in adult and pediatric patients aged 6 months and older.
• A caregiver or a patient at least 12 years of age may inject this drug using the prefilled syringe or prefilled pen; in pediatric patients aged 12 to 17 years, administer this drug under the supervision of an adult.
• In pediatric patients 6 months to less than 12 years of age, administer this drug by a caregiver.
• Consult the Instructions for Use in the manufacturer product information for detailed instructions on administration.

Storage requirements:

• Store refrigerated at 2C to 8C (36F to 46F) in the original carton to protect from light.
• If necessary, this drug may be stored at room temperature up to 25C (77F) for up to 14 days; do not store above 25C (77F).
• After removal from the refrigerator, this drug must be used within 14 days or discarded.
• Do not expose to heat or direct sunlight.
• Do not freeze or shake.

Reconstitution/preparation techniques:

• Before injection, this drug should be removed from the refrigerator and allowed to reach room temperature (45 minutes for the 300 mg prefilled syringe/pen; 30 minutes for the 200 mg prefilled syringe/pen and the 100 mg prefilled syringe) without removing the needle cap.
• The Instructions for Use in the manufacturer product information should be consulted for detailed instructions on preparation.

General:

• This drug is intended for use under the guidance of a health care provider.
• Before use, patients and/or caregivers should be properly trained on the preparation and administration of this drug according to the Instructions for Use.

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Women exposed to this drug during pregnancy are encouraged to participate in the pregnancy registry by calling 1-877-311-8972 or by visiting https://mothertobaby.org/ongoing-study/dupixent-dupilumab/.
• Discontinue this drug and seek immediate medical attention if any symptoms of systemic hypersensitivity reactions occur.
• Consult health care provider if new onset/worsening eye symptoms develop.
• Notify health care provider if you have clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis.
• Seek medical advice if asthma remains uncontrolled or worsens after starting this drug.
• Do not discontinue systemic or inhaled corticosteroids except under the direct supervision of a health care provider.
• Patients with comorbid asthma: Do not adjust or stop asthma treatment without discussing with health care providers.
• Report new onset/worsening joint symptoms to health care provider.
• Notify health care provider if you have clinical features consistent with helminthic infection.
• Missed Dose:
• If a weekly dose is missed, administer the dose as soon as possible and start a new weekly schedule based on this date.
• If an every-other-week dose is missed, administer the dose within 7 days and then resume the original schedule; if the missed dose is not administered within 7 days, wait until the next dose on the original schedule.
• If an every-4-week dose is missed, administer the dose within 7 days and then resume the original schedule; if the missed dose is not administered within 7 days, administer the dose and start a new schedule based on this date.

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