Table 2.
Characteristics of available immunoglobulin products for subcutaneous administration.
| Brand name* | Hizentra® | Gammanorm® | Subcuvia® | Subgam® | Gamunex®-C | Gammagard Liquid® |
|---|---|---|---|---|---|---|
| Manufacturer | CSL Behring (Berne, Switzerland) | Octapharma (Lachen, Switzerland) | Baxter (Deerfield, IL, USA) | Bio Products Laboratory (Elstree, UK) | Talecris (Research Triangle Park, NC, USA) | Baxter (Deerfield, IL, USA) |
| Form | Liquid | Liquid | Liquid | Liquid | Liquid | Liquid |
| IgG concentration, % | 20 | 16.5 | 16 | 16 | 10 | 10 |
| Shelf-life | 30 months at 25°C (77°F) | 36 months at 2°C–8°C (36°F–46°F) 1 month at 25°C (77°F) | 36 months at 2°C–8°C (36°F–46°F) | 24 months at 2°C–8°C (36°F–46°F) 1 week at 25°C (77°F) | 36 months at 2°C–8°C (36°F–46°F) 6 months at 25°C (77°F) | 36 months at 2°C–8°C (36°F–46°F) 12 months at 25°C (77°F) within the first 24 months of manufacture date |
| Excipients | 250 mM l-proline, 10–30 mg/L polysorbate 80, trace amounts (<10 mM) of sodium | Glycine, sodium chloride, sodium acetate equivalent to 2.5 mg of sodium per mL | Glycine, sodium chloride | Gycine, sodium chloride, sodium acetate, small quantities of sodium hydroxide, hydrochloric acid, and polysorbate 80 | 200 mM glycine, trace amounts of sodium | 250 mM glycine |
| Excipients | 250 mM l-proline, 10–30 mg/L polysorbate 80, trace amounts (<10 mM) of sodium | Glycine, sodium chloride, sodium acetate equivalent to 2.5 mg of sodium per mL | Glycine, sodium chloride | Gycine, sodium chloride, sodium acetate, small quantities of sodium hydroxide, hydrochloric acid, and polysorbate 80 | 200 mM glycine, trace amounts of sodium | 250 mM glycine |
| Maximum recommended infusion rate | 25 mL/h/infusion site (50 mL/h for all simultaneous sites) | 20 mL/h/pump (40 mL/h for all simultaneous sites) | 20 mL/h/pump (more than one pump possible) | 20 mL/h/pump (more than one pump possible) | 20 mL/h/infusion site | 20–30 mL/h/site (for bw ≥40 kg) 15–20 mL/h/site (for bw <40 kg) |
*Hizentra, Gamunex-C and Gammagard Liquid are licensed in the US. Hizentra, Gammanorm, Subcuvia, and Subgam are licensed in different European countries. Vivaglobin, a 16% subcuteaneous immunoglobin licensed in the US and Europe, was discontinued in the US in April 2011 and will be replaced with Hizentra in Europe until the end of 2012; therefore, it is not included in this table. bw=body weight; IgG=immunoglobulin G.