Tuesday, November 24, 2020

ORENCIA

ORENCIA® (abatacept) is a selective T cell costimulatory modulator. ORENCIA is a soluble fusion protein consisting of the extracellular domain of human cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), which is combined with the modified Fc (hinge, CH2 and CH3 domains) of human immunoglobulin G1 (IgG1) Partially connected. Abatacept is produced in a mammalian cell expression system through recombinant DNA technology. The apparent molecular weight of abatacept is 92 kilodaltons.

ORENCIA injection is a lyophilized powder for intravenous infusion. ORENCIA injection is a sterile, white, preservative-free lyophilized powder that can be reconstituted and diluted before intravenous administration. After rebuilding the lyophilized powder with 10 mL of sterile water for injection (USP), the OERNCIA solution was clear, colorless to light yellow, and the pH was 7.2 to 7.8. Each single-use ORENCIA injection bottle provides 250 mg of abatacept, maltose (500 mg), sodium dihydrogen phosphate (17.2 mg) and sodium chloride (14.6 mg) for administration.

ORENCIA injection is a sterile, preservative-free, transparent to slightly opalescent, colorless to light yellow solution, and the pH range for subcutaneous administration is 6.8 to 7.4. ORENCIA injection is provided in the form of a single-dose prefilled syringe or a single-dose ClickJect auto-injector.

ORENCIA® is suitable for reducing the symptoms and signs of adult patients with moderate to severe active rheumatoid arthritis, causing major clinical reactions, inhibiting the progression of structural damage and improving physical function. In addition to tumor necrosis factor (TNF) antagonists, OERNCIA can also be used as a monotherapy or in conjunction with disease-modifying anti-rheumatic drugs (DMARD).
Juvenile idiopathic arthritis

ORENCIA is indicated for alleviating signs and symptoms of adolescent idiopathic arthritis with moderately to severely active polyarticular joints aged 2 years and older. ORENCIA can be used as a monotherapy or in combination with methotrexate (MTX).
Adult Psoriatic Arthritis (PsA)

ORENCIA is designated for the treatment of adult patients with active psoriatic arthritis (PsA).
Important usage restrictions

ORENCIA should not be used simultaneously with TNF antagonists. It is not recommended to use ORENCIA with other biological rheumatoid arthritis (RA) treatments (such as anakinra).

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