Active Ingredient: Dupilumab
Dupilumab is indicated for the treatment of moderate to severe chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamines and who are naive to anti-IgE therapy for CSU.
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.
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.
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 case that patient weight is ≥ 30 kg and patient weight is < 60 kg
Subcutaneous, 400 milligrams dupilumab, one dose, over the duration of 2 weeks. Afterwards, 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, 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 the following table.
Dose of dupilumab for subcutaneous administration in adolescent patients 12 to 17 years of age with CSU:
| Body Weight | Initial Dose | Subsequent Doses |
|---|---|---|
| 30 to less than 60 kg | 400 mg | 200 mg every other week (Q2W) |
| 60 kg or more | 600 mg | 300 mg every other week (Q2W) |
Dupilumab dosing beyond 24 weeks has not been studied in CSU. After 24 weeks, the need for continued therapy should be periodically assessed. Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment for CSU.
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. Avoid injecting dupilumab into skin that is tender, damaged or has bruises or scars.
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