Active Ingredient: Ixekizumab
Ixekizumab, alone or in combination with methotrexate, is indicated for the treatment of active JPsA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in case that patient age in years is ≥ 6 and patient weight is ≥ 25 kg and patient weight is < 50 kg
Subcutaneous, 80 milligrams ixekizumab, one dose, over the duration of 4 weeks. Afterwards, subcutaneous, 40 milligrams ixekizumab, once every 4 weeks.
Regimen B, in case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg
Subcutaneous, 160 milligrams ixekizumab, one dose, over the duration of 4 weeks. Afterwards, subcutaneous, 80 milligrams ixekizumab, once every 4 weeks.
Efficacy and safety data is not available in children below the age of 6 years. Available data do not support a posology below a body weight of 25 kg.
The recommended dose given by subcutaneous injection in children is based on the following weight categories:
| Children's body weight | Recommended starting dose (week 0) | Recommended dose every 4 weeks (Q4W) thereafter |
|---|---|---|
| Greater than 50 kg | 160 mg | 80 mg |
| 25 to 50 kg | 80 mg | 40 mg |
Ixekizumab is not recommended for use in children with a body weight below 25 kg. Paediatric body weights must be recorded and regularly re checked prior to dosing.
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 to 20 weeks of treatment. Some patients with initially partial response may subsequently improve with continued treatment beyond 20 weeks.
Ixekizumab is for subcutaneous injection. Injection sites may be alternated. If possible, areas of the skin that show psoriasis should be avoided as injection sites. The solution/the pen must not be shaken.
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