CUTAQUIG Solution for infusion Ref.[10790] Active ingredients: Human normal immunoglobulin G

CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp), is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. CUTAQUIG is a solution for injection to be administered subcutaneously.

This preparation contains approximately 165 mg of protein per mL (16.5%), of which not less than 96% is normal human immunoglobulin G. CUTAQUIG contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 3% fragments. On average, the product contains ≤0.6 mg of IgA/mL.

The sodium content of the final solution is not more than 30 mmol/L and the pH is between 5.0 and 5.5. The osmolality is 310-380 mOsmol/kg.

The manufacturing process for CUTAQUIG isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. CUTAQUIG contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG1 is 70%, IgG2 is 25%, IgG3 is 3% and IgG4 is 2%.

CUTAQUIG contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (79 mg/mL), but no preservatives or sucrose.

All units of human plasma used in the manufacture of CUTAQUIG are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative).

The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Octoxynol. The CUTAQUIG manufacturing process shows significant viral reduction in in vitro studies (Table 5). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment.

Table 5. Pathogen Reduction During CUTAQUIG Manufacturing:

^* Not calculated for global LRF
HIV-1: Human Immunodeficiency Virus – 1
PRV: Pseudorabies Virus, model virus for e.g. Hepatitis B Virus (HBV)
SBV: Sindbis Virus model virus for Hepatitis C Virus (HCV)
MEV: Mouse Encephalomyelitis Virus, model virus for Human Parvovirus B19
PPV: Porcine Parvovirus, model virus for Hepatitis A Virus (HAV)
n.a.: not applicable