Active rheumatoid arthritis

Active Ingredient: Abatacept

Indication for Abatacept

Population group: only adults (18 years old or older)

Abatacept in combination with methotrexate is indicated for:

  • the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
  • the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate

For this indication, competent medicine agencies globally authorize below treatments:

30-minute intravenous infusion

Route of admnistration

Intravenous

Defined daily dose

10 mg per kg of body weight

Dosage regimen

10 mg per kg of body weight once every 14 day(s)

Detailed description

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 Abatacept^a^

Body Weight of PatientDoseNumber of Vials^b^
< 60 kg500 mg2
≥ 60 kg to ≤ 100 kg750 mg3
> 100 kg1,000 mg4

a Approximating 10 mg/kg.
b Each vial provides 250 mg of abatacept for administration.

No dose adjustment is required when used in combination with other DMARDs, corticosteroids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics.

Dosage considerations

To be administered as a 30-minute intravenous infusion.

Active ingredient

Abatacept

Abatacept is a fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1). Abatacept selectively modulates a key costimulatory signal required for full activation of T lymphocytes expressing CD28.

Read more about Abatacept

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