Route | Product | Dosage form | Diluent | Refrigeration required? | Filtration required? | Osmolality (mOsm/kg) | Sodium | pH | IgA (mcg/mL) | Stabilizer or regulator* | Pathogen inactivation/ removal¶ |
IV | Asceniv | 10% liquid | NA | Yes | No | Not available | 0.100 to 0.140 mol/L | 4.0 to 4.6 | <200 | Glycine and polysorbate 80 | FP, S/D, VF |
Bivigam | 10% liquid | NA | Yes | No | <510 | 100 to 140 mM | 4.0 to 4.6 | ≤200 | Glycine | FP, S/D, NF | |
Flebogamma DIF 5% | 5% liquid | NA | NoΔ | Optional | 240 to 370 | Trace | 5.0 to 6.0 | <50 | D-sorbitol | Past, S/D, dsNF, FP, PEG, pH4 | |
Flebogamma DIF 10% | 10% liquid | NA | NoΔ | No | 240 to 370 | Trace | <100 | D-sorbitol | Past, S/D, dsNF, FP, PEG, pH4 | ||
Gammagard 5% S/D | Lyophilized | Sterile water | No | Yes | 636 | 8.5 mg/mL | 6.8 | <1 | 2% glucose and glycine | CEF, CHROM, S/D | |
Gammaplex | 5% liquid | NA | NoΔ | 15 to 20 micron filter preferred | 420 to 500 | 30 to 50 mmol/L | 4.8 to 5.0 | <4 | Sorbitol and glycine and polysorbate 80 | S/D, VF, low pH | |
Gammaplex | 10% liquid | NA | NoΔ | No | ≥280 | <30 mM/L | 4.9 to 5.2 | <20 | Glycine and polysorbate 80 | S/D, VF, low pH | |
Octagam | 5% liquid | NA | NoΔ | Optional | 310 to 380 | 0.03 mEq/mL | 5.1 to 6.0 | <200 | Maltose | CEF, UF, CHROM, S/D, pH4 | |
Octagam | 10% liquid | NA | NoΔ | Optional | 310 to 380 | <30 mmol/L | 4.5 to 5.0 | 106 | Maltose | CEF, S/D, pH 4, UF, CHROM | |
Panzyga | 10% liquid | NA | No◊ | Optional | 240 to 310 | Trace | 4.5 to 5.0 | 100 | Glycine | S/D, CEF, NF, CHROM | |
Privigen | 10% liquid | NA | No | No | 240 to 440 | Trace | 4.6 to 5.0 | <25 | L-proline | CEF, CHROM, pH 4, DF, NF, OAF | |
IV or SC | Gammagard liquid | 10% liquid | NA | NoΔ | Optional | 240 to 300 | None added | 4.6 to 5.1 | 37 | Glycine | CEF, CHROM, S/D, pH 4, NF |
Gammaked | 10% liquid | NA, incompatible with saline | No§ | No | 258 | None added | 4.0 to 4.5 | 46 | Glycine | CEF, pH 4.2, DF, CAP, CHROM, NF | |
Gamunex-C | 10% liquid | NA, incompatible with saline | No§ | No | 258 | None added | 4.0 to 4.5 | 46 | Glycine | CEF, pH 4.2, DF, CAP, CHROM | |
SC | Cutaquig | 16.5% | NA | Yes¥ | No | 310 to 380 | <30 mmol/L | 5.0 to 5.5 | ≤600 | Maltose | CEF, UF, CHROM, S/D, pH 4 |
Cuvitru | 20% solution | NA | No‡ | No | 208 to 290 | None | 4.6 to 5.1 | 80 | Glycine | CEF, CHROM, NF, S/D | |
Hizentra | 20% liquid | NA | No | No | 380 | Trace, <10 mmol/L | 4.6 to 5.2 | ≤50 | Proline | CEF, CHROM, pH 4.2, DF, NF, VF, OAF | |
Hyqvia | 10% liquid + hyaluronidase, human recombinant | NA | No | No† | 240 to 300 | None added | 4.6 to 5.1 | 37 | Glycine | CEF, CHROM, S/D, pH 4, NF | |
Xembify | 20% | NA | 2 to 8°C | No | 280 to 404 | None | 4.1 to 4.8 | Not defined | Glycine | CEF, CHROM, CAP, NF, DF, low pH | |
Intramuscular | GamaSTAN | 16.5% solution | NA | 2 to 8°C | No | Not available | Not measured | 4.1 to 4.8 | Not measured | Glycine | CEF, CAP, CHROM, NF, low pH, DF |
GamaSTAN S/D** | 15 to 18% liquid | NA | 2 to 8°C | No | Not available | 0.4 to 0.5% | 6.4 to 7.2 | Not measured | Glycine | CEF, S/D, UF |
IgA: immunoglobulin A; IV: intravenous; NA: not applicable; FP: fraction precipitation; S/D: solvent detergent; VF: virus filtration; Nano, NF: nanofiltration; DIF: dual inactivation and filtration; Past: pasteurization; dsNF: double sequential nanofiltration; PEG: polyethylene glycol precipitation; CEF: cold ethanol fractionation; DF: depth filtration; UF: ultrafiltration; CHROM: chromatography; SC: subcutaneous; CAP: caprylate; OAF: octanoic acid fractionation.
* Precautions and laboratory abnormalities associated with specific stabilizers include the following. For additional information, refer to UpToDate clinical topics, immune globulin drug monograph, and labeling for specific products.¶ Pathogen inactivation/removal using CEF, DF, UF, CAP, CHROM, Nano, double sequential nanofiltration, VF, S/D, Past, FP, or OAF.
Δ Not required (+2 to 25°C).
◊ Storage is 2 to 8°C for 24 months or 25°C for 9 months.
§ Storage is 2 to 8°C for 36 months or 25°C for 6 months.
¥ Storage is 2 to 8°C for 24 months or 25°C for 6 months.
‡ Storage is 2 to 8°C for 36 months or 25°C for 12 months.
† Storage is 2 to 8°C for 36 months or 25°C for 3 months.
** GamaStan S/D has been discontinued in the United States.Original table modified for this publication. From: Perez EE, Orange JS, Bonilla F, et al. Update on the use of immunoglobulin in human disease: A review of evidence. J Allergy Clin Immunol 2017; 139:S1. Table used with the permission of Elsevier Inc. All rights reserved.
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