Active Ingredient: Dupilumab
Dupilumab 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.
Dupilumab is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 600 milligrams dupilumab, one dose, over the duration of 2 weeks. Afterwards, subcutaneous, 300 milligrams dupilumab, once every 2 weeks.
The recommended dose of dupilumab for adult patients is an initial dose of 600 mg, followed by 300 mg given every other week administered as subcutaneous injection.
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.
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.
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.
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.
For:
Regimen A: In case that patient weight is < 60 kg, subcutaneous, 400 milligrams dupilumab, one dose, over the duration of 2 weeks. Afterwards, in case that patient weight is < 60 kg, subcutaneous, 200 milligrams dupilumab, once every 2 weeks.
Regimen B: In case that patient weight is ≥ 60 kg, subcutaneous, 600 milligrams dupilumab, one dose, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 60 kg, subcutaneous, 300 milligrams dupilumab, once every 2 weeks.
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 | 200 mg |
| 60 kg or more | 600 mg | 300 mg |
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.
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.
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.
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.
For:
Regimen A: In case that patient age in years is ≥ 6 and patient age in years is ≤ 11 and patient weight is ≥ 15 kg and patient weight is < 60 kg, subcutaneous, 300 milligrams dupilumab, once every 15 days, 2 doses in total, over the duration of 43 days. Afterwards, in case that patient age in years is ≥ 6 and patient age in years is ≤ 11 and patient weight is ≥ 15 kg and patient weight is < 60 kg, subcutaneous, 300 milligrams dupilumab, once every 4 weeks.
Regimen B: In case that patient age in years is ≥ 6 and patient age in years is ≤ 11 and patient weight is ≥ 15 kg and patient weight is < 60 kg, subcutaneous, 300 milligrams dupilumab, once every 15 days, 2 doses in total, over the duration of 43 days. Afterwards, in case that patient age in years is ≥ 6 and patient age in years is ≤ 11 and patient weight is ≥ 15 kg and patient weight is < 60 kg, subcutaneous, 200 milligrams dupilumab, once every 2 weeks.
Regimen C: In case that patient age in years is ≥ 6 and patient age in years is ≤ 11 and patient weight is ≥ 60 kg, subcutaneous, 600 milligrams dupilumab, one dose, over the duration of 2 weeks. Afterwards, in case that patient age in years is ≥ 6 and patient age in years is ≤ 11 and patient weight is ≥ 60 kg, subcutaneous, 300 milligrams dupilumab, once every 2 weeks.
Regimen D: In case that patient age in months is ≥ 6 and patient age in years is ≤ 5 and patient weight is ≥ 5 kg and patient weight is < 15 kg, subcutaneous, 200 milligrams dupilumab, one dose, over the duration of 4 weeks. Afterwards, in case that patient age in months is ≥ 6 and patient age in years is ≤ 5 and patient weight is ≥ 5 kg and patient weight is < 15 kg, subcutaneous, 200 milligrams dupilumab, once every 4 weeks.
Regimen E: In case that patient age in months is ≥ 6 and patient age in years is ≤ 5 and patient weight is ≥ 15 kg and patient weight is < 30 kg, subcutaneous, 300 milligrams dupilumab, one dose, over the duration of 4 weeks. Afterwards, in case that patient age in months is ≥ 6 and patient age in years is ≤ 5 and patient weight is ≥ 15 kg and patient weight is < 30 kg, subcutaneous, 300 milligrams dupilumab, once every 4 weeks.
The recommended dose of dupilumab for children 6 to 11 years of age is specified in Table 1.
Table 1. 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 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 | 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 2.
Table 2. 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 | 200 mg every 4 weeks (Q4W) |
| 15 kg to less than 30 kg | 300 mg | 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.
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.
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.
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.
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