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GAMMAGARD Therapy
Find detailedIVIG Product Selection
There are a number of intravenous immunoglobulin (IVIG) products on the market. Although they are considered to be therapeutically equivalent, there are pharmaceutical and formulation differences which should be considered. Some products may be more appropriate for specific patients due to differences in sugar content and IgA content, as well as differences in pH, sodium content, and osmolality.1
The following considerations can be particularly important in product selection.
Sugar content:
Sugars, including sorbitol, maltose and sucrose, are used as stabilizers in some products. Products containing sugars have been associated with increased risk of exacerbating or causing renal dysfunction in the elderly and in patients with underlying renal disease.7
IgA levels:
Patients who have low to undetectable levels of IgA may be at risk for anaphylaxis if they produce IgE or IgG against IgA present in IVIG. Since different formulations have different amounts of IgA, and testing to determine sensitivity may not be available, IgA content in IGIV may be a consideration in product selection.7
Product Characteristics of Available Baxter1 IVIG Therapeutics
| GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% |
GAMMAGARD SD [Immune Globulin Intravenous (Human)] |
GAMMAGARD SD IgA < 1µg/mL in a 5% solution [Immune Globulin Intravenous (Human)] |
|
| Form | Liquid | Lyophilized | Lyophilized |
| Method of Administration | Intravenous | Intravenous | Intravenous |
| Indications | PI | PI, ITP, CLL, Kawasaki Syndrome | PI, ITP, CLL, Kawasaki Syndrome |
| Contraindications | In patients with known anaphylactic or severe hypersensitivity response to immune globulin (human); Patient with severe, selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction | Patients with selective IgA deficiency, where IgA deficiency is the only abnormality of concern | Patients with selective IgA deficiency, where IgA deficiency is the only abnormality of concern |
| IgA Content | 37 µg/mL | < 2.2 µg/mL in a 5% solution | < 1.0 μg/mL in a 5% solution |
| Sugar Content | No added sugar | 20 mg/mL glucose in a 5% solution |
20 mg/mL glucose in a 5% solution |
| Sodium Content | No added sodium | 8.5 mg/mL (5%) | 8.5 mg/mL (5%) |
| Number of Dedicated* Viral Inactivation/ Removal Steps | Three: S/D treatment, 35nm nanofiltration, Low pH at elevated temperature | One: S/D treatment | One: S/D treatment |
| pH when Liquid | 4.6 - 5.1 | 6.8 ± 0.4 | 6.8 ± 0.4 |
| Osmolality/Osmolarity | 240 – 300 mOsmol/kg | 636 mOsm/kg (5%) 1250 mOsm/L (10%) |
636 mOsm/kg (5%) 1250 mOsm/L (10%) |
| Maximum Infusion Rate | 0.083 mL/kg/min (5.0 mL/kg/hr) 8.9 mg/kg/min | 5%: 0.066 mL/kg/min (4 mL/kg/hr) 10%: 0.133 mL/kg/min (8 mL/kg/hr) |
5%: 0.066 mL/kg/min (4 mL/kg/hr) 10%: 0.133 mL/kg/min (8 mL/kg/hr) |
| Packaging/Labeling Enhancements6 | Tamper evident integral flip-top cap, RSS bar code, Baxter watermark and microprinting on carton; Peel-off vial labels with lot number/expiration date using color-shifting inks and security slits; Other covert security measures | Tamper evident cap, peel-off label with lot number/expiration date | Tamper evident cap, peel-off label with lot number/expiration date |
| Shelf Life/Storage Requirements | 36 months at refrigerated temperature 2°–8°C (36°–46°F); Up to 9 months at 25°C (77°F) within 24 months date of manufacture; Do not freeze | 24 months room temperature, not to exceed 25°C (77°F); Do not freeze |
24 months room temperature, not to exceed 25°C (77°F); Do not freeze |
| Vial Sizes | 20g, 10g, 5g, 2.5g, 1g | 10g, 5g, 2.5g | 10g, 5g |
Product Characteristics of Other Available IVIG Therapeutics
| CARIMUNE NF 3%, 6%, 9% or 12% [Immune Globulin Intravenous (Human)] |
Privigen [Immune Globulin Intravenous (Human)] 10% |
VIVAGLOBIM 16% [Immune Globulin Subcutaneous (Human)] |
|
| Manufacturer | CSL Behring2 | CSL Behring2 | CSL Behring2 |
| Form | Lyophilized | Liquid | Liquid |
| Method of Administration | Intravenous | Intravenous | Subcutaneous |
| Indications | PI, ITP | PI, ITP | PI |
| Contraindications | In patients with selective IgA deficiency, who possess antibody to IgA and patients who have had severe systemic reactions to the IV or IM adminstration of human immune globulin | Anaphylactic or severe systemic reactions to human immunoglobulin Hyperprolinemia Selective IgA deficiencies with known antibody against IgA |
Anaphylactic or severe systemic reactions to human immunoglobulin Selective IgA deficiencies with known antibody against IgA |
| IgA Content | 720 µg/mL | ≤ 25 µg/mL | ≤ 1700 µg/mL |
| Sugar Content | 1.67 g sucrose per g protein | No sugar added | None |
| Sodium Content | < 20 mg sodium chloride per g protein | Trace amounts | 0.3% sodium chloride |
| Number of Dedicated* Viral Inactivation/ Removal Steps | Three: fractionation and depth filtration, pH 4/Pepsin, 50nm nanofiltration |
Two: pH 4 incubation, virus filtration | Two: ethanol-fatty alcohol/pH precipitation and pasteurization |
| pH when Liquid | 6.6 ± 0.2 | 4.6 - 5.0 | 6.4 - 7.2 |
| Osmolality/Osmolarity | 192 – 1074 mOsm/kg (depends on diluent type, concentration and volume) |
240–440 mOsmol/kg | Not Applicable |
| Maximum Infusion Rate | 0.02 mL/kg/min (1.2 mL/kg/hr) < 2 mg/kg/min |
PI: 0.08 mL/kg/min
(4.8 mL/kg/hr) 8.0 mg/kg/min ITP: 0.04 mL/kg/min (2.4 mL/kg/hr) 4.0 mL/kg/min |
15 mL per injection site at a rate of 20 mL/hr |
| Packaging/Labeling Enhancements6 | Tamper-evident seal, RSS bar code, peeloff label with lot number/expiration date | Tamper-evident seal, RSS bar code, peeloff label with lot number/expiration date | Latex-free packaging |
| Shelf Life/Storage Requirements | Room temperature, not to exceed 30°C (86°F) until expiration date | 24 months room temperature, not to exceed 25°C (77°F); Do not freeze; Protect from light | Refrigerated temperature 2°–8°C until expiration date on label; Do not freeze |
| Vial Sizes | 12g, 6g, 3g | 20g, 10g, 5g | 20mL, 10mL, 3mL |
Product Characteristics of Other Available IVIG
Therapeutics
(Continued)
| FLEBOGAMMA 5% DIF [Immune Globulin Intravenous (Human)] |
OCTAGAM [Immune Globulin Intravenous (Human)] |
GAMUNEX [Immune Globulin Intravenous (Human)], 10% Caprylate/ Chromatography Purified |
|
| Manufacturer | Grifols3 | Octapharma4 | Talecris5 |
| Form | Liquid | Liquid | Liquid |
| Method of Administration | Intravenous | Intravenous | Intravenous |
| Indications | PI | PI | CIDP, PI, ITP |
| Contraindications | Selective IgA deficiency/demonstrable antibodies to IgA; History of severe or anaphylactic reations to blood or blood-derived products | Intolerance to homologous immunoglobulins, especially patients with selective IgA deficiency when patient has IgE mediated antibodies to IgA | Anaphylactic or severe systemic reactions to human immunoglobulin Selective IgA deficiencies with antibodies against IgA and a history of hypersensitivity |
| IgA Content | < 50 µg/mL | ≤ 0.2 mg/mL | 46 µgmL |
| Sugar Content | 5 g D-sorbitol in 100mL of water for injection | 100 mg/mL maltose | No sugar |
| Sodium Content | < 3.2 mmol/L | ≤ 30 mmol/L | Trace amounts |
| Number of Dedicated* Viral Inactivation/ Removal Steps | Three: Pastuerization, S/D treatment, double nanofiltration (35 nm, 20 nm filters) | Two: S/D treatment, pH4 treatment | Two: Caprylate chromatography purified and low pH incubation |
| pH when Liquid | 5.0–6.0 | 5.1 – 6.0 | 4.0 – 4.5 |
| Osmolality/Osmolarity | 240 – 370 mOsm/L | 310 – 380 mOsm/kg | 258 mOsm/kg |
| Maximum Infusion Rate | 0.10 mL/kg/min (6.0 mL/kg/hr) 5 mg/kg/min |
0.07 mL/kg/min (4.2 mL/kg/hr) 3.3 mg/kg/min |
0.08 mL/kg/min (4.8 mL/kg/hr) 8 mg/kg/min |
| Packaging/Labeling Enhancements6 | Tamper-evident closure, laser-etched vials with individual vial information, bar-coded, peel-off label with product and lot number information | Tamper-evident, latex-free packaging, peel-off label with lot number/expiration date | Tamper-evident packaging, peel-off label with lot number/expiration date |
| Shelf Life/Storage Requirements | 2° – 25°C (36° – 77°F) until expiration date; Do not freeze | 24 months 2° – 8°C (36° – 46°F); or 18 months at temperatures not to exceed +25°C (77°F) until expiration date |
36 months at refrigerated temperature 2° – 8°C (36° – 46°F); Up to 6 months at 25°C (77°F); Do not freeze |
| Vial Sizes | 20g, 10g, 5g, 2.5g, 0.5g | 25g, 10g, 5g, 2.5g, 1g | 20g, 10g, 5g, 2.5g, 1g |
* Dedicated inactivation/removal steps are introduced into the manufacturing process for the sole purpose of reducing pathogens, critical parameters can be optimized and standardized to ensure reliable and constant performance across many production runs. Other processing steps such as cold ethanol fractionation which contribute to pathogen reduction are considered advantageous.
- GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% package insert. Westlake Village, CA. Baxter International Inc.; October 2009.
- Carimune NF Package Insert, revised June 2007. <www.cslbehring-us.com>
Privigen Package Insert, revised July 2007. <www.privigen.com> Vivaglobin Package Insert, revised April 2007. <www.vivagloben.com> - Flebogamma 5% DIF Package Insert, revised November 2006. <www.grifols.com>
- Octogam Package Insert, revised August 2006. <www.octapharma.com>
- Gamunex Package Insert, revised October 2008. <www.gamunex.com>
- Pharmacy Practice News Special Edition 2009 Immune Globulins: Therapeutic, Pharmaceutical and Cost Considerations.
- Blaese M, ed. IDF Guide for Nurses. Towson, MD; Immune Deficiency Foundation; 2007: p.6.
