Active Ingredient: Abatacept
Abatacept in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in paediatric patients 2 years of age and older administered intravenously and in paediatric patients 6 years of age and older administered subcutaneously, who have had an insufficient response to other DMARDs including at least one TNF inhibitor.
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 < 75 kg, intravenous, 10 milligrams abatacept per kilogram of body weight, once every 2 weeks, 3 doses in total, over the duration of 8 weeks. Afterwards, in case that patient age in years is ≥ 6 and patient weight is < 75 kg, intravenous, 10 milligrams abatacept per kilogram of body weight, once every 4 weeks.
Regimen B: In case that patient age in years is ≥ 6 and patient weight is ≥ 60 kg and patient weight is ≤ 100 kg, intravenous, 750 milligrams abatacept, once every 2 weeks, 3 doses in total, over the duration of 8 weeks. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 60 kg and patient weight is ≤ 100 kg, intravenous, 750 milligrams abatacept, once every 4 weeks.
Regimen C: In case that patient age in years is ≥ 6 and patient weight is > 100 kg, intravenous, 1,000 milligrams abatacept, once every 2 weeks, 3 doses in total, over the duration of 8 weeks. Afterwards, in case that patient age in years is ≥ 6 and patient weight is > 100 kg, intravenous, 1,000 milligrams abatacept, once every 4 weeks.
The recommended dose of abatacept for patients 6 to 17 years of age with juvenile idiopathic arthritis who weigh less than 75 kg is 10 mg/kg calculated based on the patient’s body weight at each administration. Paediatric patients weighing 75 kg or more should be administered abatacept following the adult dosing regimen (Table 1), not to exceed a maximum dose of 1,000 mg. Abatacept should be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept should be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter.
Table 1. Dose of abatacepta:
| Body Weight of Patient | Dose |
|---|---|
| <60 kg | 500 mg |
| ≥60 kg to ≤100 kg | 750 mg |
| >100 kg | 1,000 mg |
a Approximating 10 mg/kg.
The safety and efficacy of abatacept in children below 6 years of age have not been studied and therefore, abatacept is not recommended for use in children under six years old.
The entire, fully diluted abatacept solution should be administered over a period of 30 minutes and must be administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 to 1.2 μm).
For:
Regimen A: In case that patient weight is ≥ 10 kg and patient weight is < 25 kg, subcutaneous, 50 milligrams abatacept, once weekly.
Regimen B: In case that patient weight is ≥ 25 kg and patient weight is < 50 kg, subcutaneous, 87.5 milligrams abatacept, once weekly.
Regimen C: In case that patient weight is ≥ 50 kg, subcutaneous, 125 milligrams abatacept, once weekly.
The recommended weekly dose of abatacept solution for injection for patients 2 to 17 years of age with polyarticular juvenile idiopathic arthritis should be initiated without an intravenous loading dose and administered utilizing the weight range-based dosing as specified in the table below:
Table 1. Weekly dose of abatacept:
| Body weight of patient | Dose |
|---|---|
| 10 kg to less than 25 kg | 50 mg |
| 25 kg to less than 50 kg | 87.5 mg |
| 50 kg or more | 125 mg |
Patients switching from abatacept intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.
Abatacept SC is intended for use under the guidance of a healthcare professional. After proper training in subcutaneous injection technique, a patient or caregiver may inject with abatacept if a physician/healthcare professional determines that it is appropriate.
Injection sites should be rotated and injections should never be given into areas where the skin is tender, bruised, red, or hard.
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