Active Ingredient: Guselkumab
Guselkumab 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 ≥ 12 kg and patient weight is ≤ 15 kg
Subcutaneous, 20 milligrams guselkumab, once every 4 weeks, 2 doses in total. Afterwards, subcutaneous, 20 milligrams guselkumab, once every 8 weeks.
Regimen B, in case that patient age in years is ≥ 6 and patient weight is ≥ 16 kg and patient weight is ≤ 19 kg
Subcutaneous, 25 milligrams guselkumab, once every 4 weeks, 2 doses in total. Afterwards, subcutaneous, 25 milligrams guselkumab, once every 8 weeks.
Regimen C, in case that patient age in years is ≥ 6 and patient weight is ≥ 20 kg and patient weight is ≤ 23 kg
Subcutaneous, 30 milligrams guselkumab, once every 4 weeks, 2 doses in total. Afterwards, subcutaneous, 30 milligrams guselkumab, once every 8 weeks.
Regimen D, in case that patient age in years is ≥ 6 and patient weight is ≥ 24 kg and patient weight is ≤ 26 kg
Subcutaneous, 35 milligrams guselkumab, once every 4 weeks, 2 doses in total. Afterwards, subcutaneous, 35 milligrams guselkumab, once every 8 weeks.
Regimen E, in case that patient age in years is ≥ 6 and patient weight is ≥ 27 kg and patient weight is ≤ 30 kg
Subcutaneous, 40 milligrams guselkumab, once every 4 weeks, 2 doses in total. Afterwards, subcutaneous, 40 milligrams guselkumab, once every 8 weeks.
Regimen F, in case that patient age in years is ≥ 6 and patient weight is ≥ 31 kg and patient weight is ≤ 39 kg
Subcutaneous, 45 milligrams guselkumab, once every 4 weeks, 2 doses in total. Afterwards, subcutaneous, 45 milligrams guselkumab, once every 8 weeks.
The recommended dose is shown below in the table below, up to a maximum of 45 mg, administered by subcutaneous injection at Weeks 0 and 4, followed by a maintenance dose every 8 weeks (q8w).
Recommended dose of guselkumab for subcutaneous injection in paediatric patients with body weight less than 40 kg:
| Body Weight (kg) (at time of dosing) | Dose (mg) |
|---|---|
| 12-15 kg | 20 |
| 16-19 kg | 25 |
| 20-23 kg | 30 |
| 24-26 kg | 35 |
| 27-30 kg | 40 |
| 31-39 kg | 45 |
The recommended dose is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks (q8w).
If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.
Subcutaneous use only. Sites for injection include the abdomen, thigh and back of the upper arm. Guselkumab should not be injected into areas where the skin is tender, bruised, red, hard, thick or scaly. If possible, areas of the skin that show psoriasis should be avoided as injection sites.
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