TABLE 14.
Product Features of Hizentra™ and Vivaglobin®
| Feature | Vivaglobin® | Hizentra™ |
|---|---|---|
| Concentration/form/administration | 16% liquid SCIg | 20% liquid SCIg |
| Storage | Refrigerate at 36°F – 46°F (2°C – 8°C) | Room temperature up to 77°F (25°C) for 18 months |
| Stabilizer | Glycine | Proline* |
| Annual rate of serious bacterial infections (SBIs) | 0.04 SBIs† per subject year | 0 SBIs‡ per subject year |
| Annual rate of any infections | 4.4 per subject year | 2.76 per subject year |
| Infusion rate | Initial infusion at 15 mL/hr/site, as tolerated; gradually increase to 20 mL/hr/site, as tolerated | Initial infusion at 15 mL/hr/site; may be increased, as tolerated, to 25 mL/hr/site§ |
| IgA content | ≤ 1700 mcg/mLa | ≤ 50 mcg/mL |
| IgG purity | ≥ 96% | ≥ 98% |
| Sucrose/sugars | None | None |
| Sodium | 3 mg/mL | Trace (≤ 10 mmol/L) |
| Latex-free | Product and packaging | Product and packaging |
| pH | 6.5–7.3 | 4.6–5.2 |
| Osmolality (mOsmol/kg) | 445 | 380 |
| Viral Inactivation: | ||
| Partitioning | Yes (Cold alcohol fractionation) | Yes (Cold alcohol fractionation, Octanoic acid precipitation, anion exchange chromatography) |
| Inactivation | Yes (Pasteurization) | Yes (pH 4 Incubation) |
| Nanofiltration (virus filter) | No | Yes (20 nanometers filter) |
| Vial sizes (NDC) | 3 mL (0053-7596-01) 10 mL (0053-7596-10) 20 mL (0053-7596-20) |
1 g in 5 mL (44206-451-01) 2 g in 10 mL (44206-452-02) 4 g in 20 mL (44206-454-04) |
Proline is one of 20 naturally occurring amino acids that form human proteins. It can be synthesized by the human body or obtained from dietary sources. CSL Behring chose proline as the stabilizer for Hizentra™ after extensive testing and analysis of other amino acids a.
Defined as bacterial pneumonia, meningitis, sepsis, osteomyelitis, and visceral abscesses.
Defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.
Infusion rate must not exceed 50 mL/hr for all sites combined.
Data on file. CSL Behring LLC.
Note: No head-to-head studies have been conducted comparing the clinical efficacy and safety of Hizentra™ versus Vivaglobin®. Attributes listed above are directly from the prescribing information for each product.