Tuesday, September 15, 2020

ORENCIA (abatacept) Injection

DESCRIPTION

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) and a modified Fc (hinge, CH2 and CH3 domain) of human immunoglobulin G1 (IgG1). . Abatacept is produced in mammalian cell expression systems 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 reconstituting the lyophilized powder with 10 mL of sterile water for injection (USP), the ORENCIA solution is clear, colorless to light yellow, and the pH is 7.2 to 7.8. Each single-use ORENCIA injection bottle provides 250 mg 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 milky white, colorless to light yellow solution, and the pH range for subcutaneous administration is 6.8 to 7.4. named patient program ORENCIA injections are available as single-dose pre-filled syringes or single-dose ClickJect auto-injectors

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