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Manufacturer # 50242013801
Brand Actemra®
Manufacturer Genentech USA
Application Disease-Modifying Antirheumatic Agent
Container Type Prefilled Syringe
Dosage Form Injection
Generic Drug Code 35486
Generic Drug Name Tocilizumab, Preservative Free
NDC Number 50242-0138-01
Strength 162 mg / 0.9 mL
Type Subcutaneous
Volume 0.9 mL
Features
ACTEMRA (tocilizumab) is a recombinant humanized
anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the
immunoglobulin IgG1? (gamma 1, kappa) subclass with a typical H2L2
polypeptide structure
ACTEMRA solution for subcutaneous administration is supplied as a
sterile, colorless to yellowish, preservative-free liquid solution of
approximately pH 6.0
It is supplied in a 1 mL ready-to-use, single-use prefilled syringe
(PFS) with a needle safety device
Each device delivers 0.9 mL (162 mg) of ACTEMRA, in a histidine
buffered solution composed of ACTEMRA (180 mg/mL), polysorbate 80,
L-histidine and L-histidine monohydrochloride, L-arginine and L-arginine
hydrochloride, L-methionine, and water for injection