Active Ingredient: Risankizumab
Risankizumab 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 the case that patient age in years is ≥ 6 and patient weight is < 40 kg :
Subcutaneous, 55 milligrams risankizumab, one dose, over the duration of 4 weeks. Afterwards, subcutaneous, 55 milligrams risankizumab, once every 12 weeks.
Regimen B, in the case that patient age in years is ≥ 6 and patient weight is ≥ 40 kg :
Subcutaneous, 150 milligrams risankizumab, one dose, over the duration of 4 weeks. Afterwards, subcutaneous, 150 milligrams risankizumab, once every 12 weeks.
The recommended dose for paediatric patients is based on body weight and administered as a subcutaneous injection at week 0, week 4, and every 12 weeks thereafter.
Recommended dose for paediatric plaque psoriasis:
| Body weight at time of dosing | Recommended dose |
| <40 kg | 55 mg |
| ≥40 kg | 150 mg |
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Some plaque psoriasis patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.
The injection should be administered in the thigh or abdomen. Patients should not inject into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.
In children and adolescents 10 to less than 18 years of age, it is recommended that risankizumab injection is administered by or under the supervision of an adult. In children 6 to less than 10 years of age, the injection should be administered by an adult. Patients should be instructed to read the 'Instructions for use' provided in the package leaflet before administration.
Administration of the injection in the upper, outer arm may only be performed by a healthcare professional or caregiver.
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