Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy.
Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Dupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
Dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy (see section 5.1).
Dupixent is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate (see Section 5.1).
Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of conditions for which dupilumab is indicated (see section 4.1).
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.
The recommended dose of dupilumab for adolescent patients 12 to 17 years of age is specified in Table 1.
Table 1. Dose of dupilumab for subcutaneous administration in adolescent patients 12 years to 17 years of age with atopic dermatitis:
| Body weight of patient | Initial dose | Subsequent doses (every other week) |
|---|---|---|
| less than 60 kg | 400 mg (two 200 mg injections) | 200 mg |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg |
The recommended dose of dupilumab for children 6 to 11 years of age is specified in Table 2.
Table 2. Dose of dupilumab for subcutaneous administration in children 6 to 11 years of age with atopic dermatitis:
| Body weight of patient | Initial dose | Subsequent doses |
|---|---|---|
| 15 kg to less than 60 kg | 300 mg (one 300 mg injection) on Day 1, followed by 300 mg on Day 15 | 300 mg every 4 weeks (Q4W)*, starting 4 weeks after Day 15 dose |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every other week (Q2W) |
* the dose may be increased to 200 mg Q2W in patients with body weight of 15 kg to less than 60 kg based on physician’s assessment.
The recommended dose of dupilumab for children 6 months to 5 years of age is specified in Table 3.
Table 3. Dose of dupilumab for subcutaneous administration in children 6 months to 5 years of age with atopic dermatitis:
| Body Weight of Patient | Initial Dose | Subsequent Doses |
|---|---|---|
| 5 kg to less than 15 kg | 200 mg (one 200 mg injection) | 200 mg every 4 weeks (Q4W) |
| 15 kg to less than 30 kg | 300 mg (one 300 mg injection) | 300 mg every 4 weeks (Q4W) |
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 re-treated.
The recommended dose of dupilumab for adults and adolescents (12 years of age and older) is:
The recommended dose of dupilumab for paediatric patients 6 to 11 years of age is specified in Table 4.
Table 4. Dose of dupilumab for subcutaneous administration in children 6 to 11 years of age with asthma:
| Body weight | Initial and subsequent doses |
|---|---|
| 15 to less than 30 kg | 300 mg every four weeks (Q4W) |
| 30 kg to less than 60 kg | 200 mg every other week (Q2W) or 300 mg every four weeks (Q4W) |
| 60 kg or more | 200 mg every other week (Q2W) |
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 2.
Patients receiving concomitant oral corticosteroids may reduce their steroid dose once clinical improvement with dupilumab has occurred (see section 5.1). Steroid reductions should be accomplished gradually (see section 4.4).
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.
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.
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.
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.
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.
No dose adjustment is recommended for elderly (≥65 years) patients (see section 5.2).
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 section 5.2).
No data are available in patients with hepatic impairment (see section 5.2).
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, CRSwNP, PN, or COPD (see section 5.2).
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.
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.
The safety and efficacy of dupilumab in children with COPD below the age of 18 years have not been established. No data are available.
Subcutaneous use.
The dupilumab pre-filled pen is for use in adult and paediatric patients aged 2 years and older. The dupilumab pre-filled syringe is for use in adult and paediatric patients aged 6 months and older. The dupilumab pre-filled pen is not intended for use in children below 2 years of age.
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 or pre-filled pen is for single use only.
For indications that require an initial dose of 600 mg (see Posology in section 4.2), 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 according to the Instructions for Use (IFU) section at the end of the package leaflet. In children 12 years of age and older, it is recommended that dupilumab is administered by or under supervision of an adult. In children 6 months to less than 12 years of age, dupilumab should be given by a caregiver.
There is no specific treatment for dupilumab overdose. In the event of overdose, the patient should be monitored for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.
3 years.
If necessary, the pre-filled syringe or pre-filled pen can be removed from the refrigerator and kept in the pack for up to 14 days at room temperature up to 25°C, while protected from light. The date of removal from the refrigerator shall be recorded in the space provided on the outer carton. The pack must be discarded if left out of the refrigerator for more than 14 days or if the expiry date has passed.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original carton in order to protect from light.
2 mL solution in a siliconised type-1 clear glass pre-filled syringe with needle shield, with a fixed 27 gauge 12.7 mm (½ inch), thin wall stainless steel staked needle.
Pack size:
2 mL solution in a siliconised type-1 clear glass syringe in a pre-filled pen, with a fixed 27 gauge 12.7 mm (½ inch), thin wall stainless steel staked needle.
The pre-filled pen is available either with a round cap and oval viewing window encircled with an arrow or with a square cap with ridges and an oval viewing window without an arrow.
Pack size:
Not all pack sizes may be marketed.
Comprehensive instructions for the administration of Dupixent in a pre-filled syringe or in a pre-filled pen are given at the end of the package leaflet.
The solution should be clear to slightly opalescent, colourless to pale yellow. If the solution is cloudy, discoloured or contains visible particulate matter, the solution should not be used.
After removing the 300 mg pre-filled syringe or pre-filled pen from the refrigerator, it should be allowed to reach room temperature up to 25°C by waiting for 45 min before injecting Dupixent.
The pre-filled syringe or the pre-filled pen should not be exposed to heat or direct sunlight and should not be shaken.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. After use, place the pre-filled syringe or the pre-filled pen into a puncture-resistant container and discard as required by local regulations. Do not recycle the container.
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