Active Ingredient: Abatacept
Abatacept, in combination with methotrexate, is indicated for:
A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 125 milligrams abatacept, once weekly.
Abatacept subcutaneous (SC) may be initiated with or without an intravenous (IV) loading dose. Abatacept SC should be administered weekly at a dose of 125 mg abatacept by subcutaneous injection regardless of weight. If a single IV infusion is given to initiate treatment (IV loading dose before SC administration), the first 125 mg abatacept SC should be administered within a day of the IV infusion, followed by the weekly 125 mg abatacept SC injections.
Patients switching from abatacept intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.
No dose adjustment is required when used in combination with other DMARDs, corticosteroids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics.
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.
For:
Regimen A, in case that patient weight is < 60 kg
Intravenous, 500 milligrams abatacept, once every 2 weeks, 3 doses in total, over the duration of 8 weeks. Afterwards, intravenous, 500 milligrams abatacept, once every 4 weeks.
Regimen B, in case that 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, intravenous, 750 milligrams abatacept, once every 4 weeks.
Regimen C, in case that 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, intravenous, 1,000 milligrams abatacept, once every 4 weeks.
To be administered as a 30-minute intravenous infusion at the dose specified in Table 1. Following the initial administration, abatacept should be given 2 and 4 weeks after the first infusion, then 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.
No dose adjustment is required when used in combination with other DMARDs, corticosteroids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics.
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).
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