Active Ingredient: Secukinumab
Secukinumab is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic 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, subcutaneous, 75 milligrams secukinumab, once weekly, 5 doses in total. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≤ 25 kg, subcutaneous, 75 milligrams secukinumab, once monthly.
Regimen B: In case that patient age in years is ≥ 6 and patient weight is ≥ 25 kg and patient weight is ≤ 50 kg, subcutaneous, 75 milligrams secukinumab, once weekly, 5 doses in total. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 25 kg and patient weight is ≤ 50 kg, subcutaneous, 75 milligrams secukinumab, once monthly.
Regimen C: In case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, subcutaneous, 150 milligrams secukinumab, once weekly, 5 doses in total. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, subcutaneous, between 150 milligrams secukinumab and 300 milligrams secukinumab, once monthly.
The recommended dose is based on body weight (Table 1) and administered by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 75 mg dose is given as one subcutaneous injection of 75 mg. Each 150 mg dose is given as one subcutaneous injection of 150 mg. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
Table 1. Recommended dose for paediatric plaque psoriasis:
Body weight at time of dosing | Recommended dose |
---|---|
<25 kg | 75 mg |
25 to <50 kg | 75 mg |
≥50 kg | 150 mg (*may be increased to 300 mg) |
* Some patients may derive additional benefit from the higher dose.
Available data suggest that a clinical response is usually achieved within 16 weeks of treatment. Consideration should be given to discontinuing treatment in patients who have shown no response by 16 weeks of treatment. Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Secukinumab is to be administered by subcutaneous injection. If possible, areas of the skin that show psoriasis should be avoided as injection sites.
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