Active Ingredient: Dupilumab
Dupilumab 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) who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Dupilumab 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) who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Subcutaneous, 600 milligrams dupilumab, one dose, over the duration of 2 weeks. Afterwards, subcutaneous, 300 milligrams dupilumab, once every 2 weeks.
Regimen B: Subcutaneous, 400 milligrams dupilumab, one dose, over the duration of 2 weeks. Afterwards, subcutaneous, 400 milligrams dupilumab, once every 2 weeks.
The recommended dose of dupilumab for adults and adolescents (12 years of age and older) is:
Patients receiving concomitant oral corticosteroids may reduce their steroid dose once clinical improvement with dupilumab has occurred. Steroid reductions should be accomplished gradually.
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.
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
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 < 30 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 ≥ 30 kg and patient weight is < 60 kg, subcutaneous, 300 milligrams dupilumab, once every 4 weeks.
Regimen C: In case that patient age in years is ≥ 6 and patient age in years is ≤ 11 and patient weight is ≥ 30 kg and patient weight is < 60 kg, subcutaneous, 200 milligrams dupilumab, once every 2 weeks.
Regimen D: In case that patient age in years is ≥ 6 and patient age in years is ≤ 11 and patient weight is > 60 kg, subcutaneous, 200 milligrams dupilumab, once every 2 weeks.
The recommended dose of dupilumab for paediatric patients 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 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.
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 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.
Patients receiving concomitant oral corticosteroids may reduce their steroid dose once clinical improvement with dupilumab has occurred. Steroid reductions should be accomplished gradually.
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
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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