Available immunoglobulin products and their properties

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	No^Δ	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	No^Δ	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	No^Δ	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	No^Δ	No	≥280	<30 mM/L	4.9 to 5.2	<20	Glycine and polysorbate 80	S/D, VF, low pH
	Octagam	5% liquid	NA	No^Δ	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	No^Δ	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	No^Δ	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
Intramuscular	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

Brand names and descriptions refer to products available in the United States and some other countries; product availability, specific composition, and other details regarding individual products vary in other countries. Refer to additional UpToDate topics on immune globulin therapy and product inserts for the indications and use of these products.

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.

Glucose: May alter glycemic control in patients with diabetes mellitus
L-proline: Cannot be used in patients with hyperprolinemia
Maltose: Falsely elevates glucose readings in certain blood glucose monitoring systems; may contain trace corn protein (potential allergen); may increase plasma osmolality (usually not clinically important)
Polysorbate 80: Some patients may be hypersensitive (also known as Tween 80); reactions can be delayed type
Sorbitol, D-sorbitol: Cannot be used in patients with hereditary fructose intolerance
Sucrose: Avoid in patients with renal impairment or increased risk of acute kidney injury

¶ 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.

Additional data from:

US Food & Drug Administration. Licensed biological products with supporting documents. Available at: https://www.fda.gov/vaccines-blood-biologics/licensed-biological-products-supporting-documents (Accessed on February 20, 2020).
Characteristics of Immunoglobulin Products Used to Treat Primary Immunodeficiencies, Immune Deficiency Foundation. Available at: https://primaryimmune.org/publication/characteristics-ig-products-used-treat-pi-licensed-use-us (Accessed on January 23, 2023).

Graphic 116460 Version 7.0

خرید پکیج

Available immunoglobulin products and their properties