Active Ingredient: Dupilumab
Dupilumab is indicated for the treatment of eosinophilic esophagitis in adults, adolescents and children aged 1 year and older, weighing at least 15 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 300 milligrams dupilumab, once weekly.
The recommended dose of dupilumab for adults is 300 mg every week (QW).
Dupilumab is intended for long-term treatment.
If a weekly dose is missed, administer the dose as soon as possible, starting a new schedule based on this date.
No dose adjustment is recommended for elderly (≥65 years) patients.
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. Avoid injecting dupilumab into skin that is tender, damaged or has bruises or scars.
For:
Regimen A, in the case that patient weight is ≥ 15 kg and patient weight is < 30 kg :
Subcutaneous, 200 milligrams dupilumab, once every 2 weeks.
Regimen B, in the case that patient weight is ≥ 30 kg and patient weight is < 40 kg :
Subcutaneous, 300 milligrams dupilumab, once every 2 weeks.
Regimen C, in the case that patient weight is ≥ 40 kg :
Subcutaneous, 300 milligrams dupilumab, once weekly.
The recommended dose of dupilumab for adolescents and children 1 year of age and older, weighing at least 15 kg, is specified in the following table.
Dose of dupilumab for subcutaneous administration in adolescents and children 1 year of age and older with EoE:
| Body Weight | Dose |
|---|---|
| 15 to less than 30 kg | 200 mg every other week (Q2W) |
| 30 to less than 40 kg | 300 mg every other week (Q2W) |
| 40 kg or more | 300 mg every week (QW) |
Dupilumab is intended for long-term treatment.
If a weekly dose is missed, administer the dose as soon as possible, starting a new schedule based on this date.
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.
It is recommended to rotate the injection site with each injection. Avoid injecting dupilumab into skin that is tender, damaged or has bruises or scars.
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