IMAAVY Concentrate for solution for injection Ref.[115559] Active ingredients: Nipocalimab

Revision Year: 2025

Product description

Nipocalimab-aahu, a neonatal Fc receptor blocker, is a recombinant human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody, expressed in a genetically engineered Chinese hamster ovary cell line. Nipocalimab-aahu has an aglycosylated Fc region, therefore it lacks effector functions. Nipocalimab-aahu has an approximate molecular weight of 142 kilodaltons (kDa).

IMAAVY (nipocalimab-aahu) injection is a sterile, preservative-free, colorless to slightly brownish, clear to slightly opalescent solution, supplied in a single-dose vial for intravenous infusion after dilution.

Each single-dose vial contains either 300 mg/1.62 mL or 1,200 mg/6.5 mL of nipocalimab-aahu at a concentration of 185 mg/mL. In addition, each mL of solution contains arginine hydrochloride (25.35 mg), histidine (0.77 mg), L-histidine monohydrochloride monohydrate (1.07 mg), methionine (1.0 mg), polysorbate 80 (0.60 mg), sucrose (64.3 mg), and water for injection, USP, at a pH of 6.0.

Dosage Forms and Strengths
Injection: colorless to slightly brownish, clear to slightly opalescent solution available as: 300 mg/1.62 mL (185 mg/mL) in a single-dose vial 1,200 mg/6.5 mL (185 mg/mL) in a single-dose vial

How Supplied
IMAAVY (nipocalimab-aahu) injection is a sterile, preservative-free, colorless to slightly brownish, clear to slightly opalescent solution for intravenous use after dilution. IMAAVY is supplied in cartons containing a single-dose vial per carton as: 300 mg/1.62 mL (185 mg/mL) NDC 57894-800-01 1,200 mg/6.5 mL (185 mg/mL) NDC 57894-801-01 Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA, U.S.

How Supplied

IMAAVY (nipocalimab-aahu) injection is a sterile, preservative-free, colorless to slightly brownish, clear to slightly opalescent solution for intravenous use after dilution.

IMAAVY is supplied in cartons containing a single-dose vial per carton as:

300 mg/1.62 mL (185 mg/mL) NDC 57894-800-01
1,200 mg/6.5 mL (185 mg/mL) NDC 57894-801-01

Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA, U.S.

Drugs

Drug	Countries
IMAAVY	Austria, Estonia, Lithuania, United States

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