ENSPRYNG Solution for injection Ref.[10377] Active ingredients: Satralizumab

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive.

ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose prefilled syringe. Each syringe delivers 1 mL of solution containing 120 mg of satralizumab-mwge, L-arginine (26.1 mg), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), L-aspartic acid (pH adjustment), and Water for Injection, USP.

Dosage Forms and Strengths

Injection: 120 mg/mL clear, and colorless to slightly yellow solution in single-dose prefilled syringe.

How Supplied

ENSPRYNG (satralizumab-mwge) injection is available as a sterile, preservative-free, clear, colorless to slightly yellow solution in single-dose prefilled syringe (PFS) with needle safety device.

ENSPRYNG PFS is not made with natural rubber latex. Each ENSPRYNG carton contains one single-dose 120 mg/mL prefilled syringe (NDC 50242-007-01).

Manufactured by: Genentech, Inc. A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990

Drugs

Drug Countries
ENSPRYNG Canada, Ecuador, Estonia, Finland, Hong Kong, Ireland, Israel, Japan, Lithuania, Poland, Romania, Turkey, United States

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