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Table 3 Current US-available high-concentration and facilitated immunoglobulin products and their properties

From: A clinician’s guide for administration of high-concentration and facilitated subcutaneous immunoglobulin replacement therapy in patients with primary immunodeficiency diseases

Route

Producta

Dosage Form

Diluent

Osmolality

(mOsm/kg)

Sodium

pH

IgA

(mcg/mL)

Stabilizer or Regulator

Pathogen Inactivation/Removalb

SC

Cutaquig

16.5% solution

NA

310–380

 < 30 mmol/L

5.0–5.5

 ≤ 600

Maltose

CEF, UF, CHROM, S/D, pH 4

Cuvitru

20% solution

NA

208–290

None

4.6–5.1

80

Glycine

CEF, CHROM, NF, S/D

Hizentra

20% liquid

NA

380

Trace,

 < 10 mmol/L

4.6–5.2

 ≤ 50

Proline

CEF, CHROM, pH 4.2, DF, NF, VF, OAF

Hyqvia

10% liquid + hyaluronidase, human recombinant

NA

240–300

None added

4.6–5.1

37

Glycine

CEF, CHROM, S/D, pH 4, NF

Xembify

20% solution

NA

280–404

None

4.1–4.8

Not defined

Glycine

CEF, CHROM, CAP, NF, DF, low Ph

Intramuscular

GamaSTAN

16.5% solution

NA

Not available

Not measured

4.1–4.8

Not measured

Glycine

CEF, CAP, CHROM, NF, low pH, DF

GamaSTAN S/Dc

15–18% liquid

NA

Not available

0.4–0.5%

6.4–7.2

Not measured

Glycine

CEF, S/D, UF

  1. Adapted from Perez EE et al. [11], which also describes IVIG and lower-concentration SCIG options.
  2. aBrand names and descriptions refer to products in the US and some other countries; product availability, specific composition, and other details regarding individual products vary in other countries. Refer to additional UpToDate topics on immunoglobulin therapy and product inserts for the indications and use of these products.
  3. bPathogen inactivation/removal using CEF, DF, UF, CAP, CHROM, Nano, double sequential nanofiltration, VF, S/D, Past, PEG, FP, or OAF.
  4. cGamaSTAN S/D has been discontinued in the US.
  5. CAP caprylate, CEF cold ethanol fractionation, CHROM chromatography, DIF dual inactivation and filtration, DF depth filtration, FP fraction precipitation, IV intravenous, IVIG intravenous immunoglobulin, NA not applicable, Nano NF nanofiltration, OAF octanoic acid fractionation, past pasteurization, PEG PEG precipitation, S/D solvent detergent, SC subcutaneous, SCIG subcutaneous immunoglobulin, UF ultrafiltration, US United States, VF virus filtration