Dupixent Dosage/Direction for Use

Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of conditions for which dupilumab is indicated (see Indications/Uses).
Posology: Atopic Dermatitis: Adults: The recommended dose of dupilumab for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week administered as subcutaneous injection.
Adolescents (12 to 17 years of age): The recommended dose of dupilumab for adolescent patients 12 to 17 years of age is specified in Table 23. (See Table 23.)

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Children 6 to 11 years of age: The recommended dose of dupilumab for children 6 to 11 years of age is specified in Table 24. (See Table 24.)

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Children 6 months to 5 years of age: The recommended dose of dupilumab for children 6 months to 5 years of age is specified in Table 25. (See Table 25.)

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Dupilumab can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment for atopic dermatitis. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. If dupilumab treatment interruption becomes necessary, patients can still be successfully retreated.
Asthma: Adults and adolescents: The recommended dose of dupilumab for adults and adolescents (12 years of age and older) is: For patients with severe asthma and who are on oral corticosteroids or for patients with severe asthma and co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid severe chronic rhinosinusitis with nasal polyposis, an initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week administered as subcutaneous injection.
For all other patients, an initial dose of 400 mg (two 200 mg injections), followed by 200 mg every other week administered as subcutaneous injection.
Children 6 to 11 years of age: The recommended dose of dupilumab for paediatric patients 6 to 11 years of age is specified in Table 26. (See Table 26.)

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For paediatric patients (6 to 11 years old) with asthma and co-morbid severe atopic dermatitis, as per approved indication, the recommended dose should be followed in Table 24.
Patients receiving concomitant oral corticosteroids may reduce their steroid dose once clinical improvement with dupilumab has occurred (see Pharmacology: Pharmacodynamics under Actions). Steroid reductions should be accomplished gradually (see Precautions).
Dupilumab is intended for long-term treatment. The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient's level of asthma control.
300 mg: Chronic rhinosinusitis with nasal polyposis (CRSwNP): The recommended dose of dupilumab for adult patients is an initial dose of 300 mg followed by 300 mg given every other week.
Dupilumab is intended for long-term treatment. Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment for CRSwNP. Some patients with initial partial response may subsequently improve with continued treatment beyond 24 weeks.
Prurigo Nodularis (PN): The recommended dose of dupilumab for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week.
Dupilumab can be used with or without topical corticosteroids.
PN clinical trial data are available for patients treated up to 24 weeks. Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment for PN.
Eosinophilic esophagitis (EoE): The recommended dose of dupilumab for patients 12 years of age and older is 300 mg given every week (QW).
Dupilumab 300 mg QW has not been studied in patients with EoE weighing less than 40 kg.
Dupilumab is intended for long-term treatment. Dupilumab 300 mg QW has been studied up to 52 weeks. Dosing beyond 52 weeks has not been studied.
Missed dose: If a weekly dose is missed, administer the dose as soon as possible, starting a new schedule based on this date.
If an every other week dose is missed, administer the injection within 7 days from the missed dose and then resume the patient's 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 injection within 7 days from the missed dose and then resume the patient's original schedule. If the missed dose is not administered within 7 days, administer the dose, starting a new schedule based on this date.
Special populations: Elderly (≥65 years): No dose adjustment is recommended for elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is needed in patients with mild or moderate renal impairment. Very limited data are available in patients with severe renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No data are available in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Body weight: No dose adjustment for body weight is recommended for patients with asthma and EoE 12 years of age and older or in adults with atopic dermatitis or CRSwNP, or PN (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of dupilumab in children with atopic dermatitis below the age of 6 months have not been established. The safety and efficacy of dupilumab in children with a body weight <5 kg have not been established. No data are available.
The safety and efficacy of dupilumab in children with severe asthma below the age of 6 years have not been established. No data are available.
300 mg: The safety and efficacy in children with CRSwNP below the age of 18 years have not been established. No data are available.
The safety and efficacy of dupilumab in children with PN below the age of 18 years have not been established. No data are available.
The safety and efficacy of dupilumab in children with EoE below the age of 12 years have not been established.
Method of administration: Subcutaneous use.
For children 6 months to 11 years of age with atopic dermatitis and asthma, the dupilumab pre-filled syringe is the presentation appropriate for administration to this population.
Dupilumab is administered by subcutaneous injection into the thigh or abdomen, except for the 5 cm around the navel. If somebody else administers the injection, the upper arm can also be used.
Each pre-filled syringe is for single use only.
For the initial 600 mg dose, two 300 mg injections should be administered consecutively in different injection sites.
It is recommended to rotate the injection site with each injection. Dupilumab should not be injected into skin that is tender, damaged or has bruises or scars.
A patient may self-inject dupilumab or the patient's caregiver may administer dupilumab if their healthcare professional determines that this is appropriate. Proper training should be provided to patients and/or caregivers on the preparation and administration of dupilumab prior to use (see Patient Counselling Information).