SARCLISA Concentrate solution for injection Ref.[10339] Active ingredients: Isatuximab

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

Product description

Isatuximab-irfc, a CD38-directed cytolytic antibody, is a chimeric immunoglobulin G1 (IgG1) monoclonal antibody (mAb). Isatuximab-irfc is produced from a mammalian cell line (Chinese hamster ovary, CHO) using a fed-batch production process. Isatuximab-irfc is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 148 kDa.

SARCLISA (isatuximab-irfc) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, essentially free of visible particles in a single-dose vial for intravenous use. Each vial contains either 100 mg/5 mL or 500 mg/25 mL of isatuximab-irfc at a concentration of 20 mg/mL with a pH of 6.0. Each mL of solution contains 20 mg isatuximab-irfc, histidine (1.46 mg), histidine hydrochloride monohydrate (2.22 mg), polysorbate 80 (0.2 mg), sucrose (100 mg), and water for injection.

Dosage Forms and Strengths

SARCLISA is a clear to slightly opalescent, colorless to slightly yellow solution, essentially free of visible particulates available as:

  • Injection: 100 mg/5 mL (20 mg/mL) in a single-dose vial
  • Injection: 500 mg/25 mL (20 mg/mL) in a single-dose vial
How Supplied

SARCLISA (isatuximab-irfc) injection is a clear to slightly opalescent, colorless to slightly yellow solution, essentially free of visible particulates, supplied as follows:

  • One 100 mg/5 mL single-dose vial in a carton: NDC 0024-0654-01
  • One 500 mg/25 mL single-dose vial in a carton: NDC 0024-0656-01

Drugs

Drug Countries
SARCLISA Austria, Brazil, Canada, Estonia, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States

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