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GAMMAGARD S/D
Immune Globulin Intravenous (Human)
SOLVENT DETERGENT TREATED
GAMMAGARD S/D, Immune Globulin Intravenous (Human) [IGIV] is a solvent/detergent treated, sterile, freeze-dried preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. The product is manufactured by the Cohn-Oncley cold ethanol fractionation process followed by ultrafiltration and ion exchange chromatography. Source material for fractionation may be obtained from another U.S. licensed manufacturer. The manufacturing process includes treatment with an organic solvent/detergent mixture,1,2 composed of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80.3 The GAMMAGARD (immune globulin) S/D manufacturing process provides a significant viral reduction in in vitro studies.3 These studies, summarized in Table 1, demonstrate virus clearance during GAMMAGARD S/D manufacturing using infectious human immunodeficiency virus, Types 1 and 2 (HIV-1, HIV-2); bovine viral diarrhea virus (BVD), a model virus for hepatitis C virus; sindbis virus (SIN), a model virus for lipid-enveloped viruses; pseudorabies virus (PRV), a model virus for lipid-enveloped DNA viruses such as herpes; vesicular stomatitis virus (VSV), a model virus for lipid-enveloped RNA viruses; hepatitis A virus (HAV) and encephalomyocarditis virus (EMC), a model virus for non-lipid enveloped RNA viruses; and porcine parvovirus (PPV), a model virus for non-lipid enveloped DNA viruses.3 These reductions are achieved through a combination of process chemistry, partitioning and/or inactivation during cold ethanol fractionation and the solvent/detergent treatment.3
Table 1: In Vitro Virus Clearance During Gammagard S/D (immune globulin) Manufacturing
| Process Step Evaluated | Virus Clearance (log10) | ||||||||
| Lipid Enveloped Viruses | Non-Lipid Enveloped Viruses | ||||||||
| BVD | HIV-1 | HIV-2 | PRV | SIN | VSV | EMC | HAV | PPV | |
| Step 1 : Processing of Cryo-Poor Plasma to Fraction I+II+III Precipitate | 0.6* | 5.7 | NT | 1.0* | NT | NT | NT | 0.5* | 0.2* |
| Step 2 : Processing of Resuspended Suspension A Precipitate to Suspension B Filter Press Filtrate | 1.3 | 4.9 | NT | 3.7 | NT | NT | 3.7 | 4.1 | 3.5 |
| Step 3 : Processing of Suspension B Filter Press to Suspension B Cuno 70 Filtrate | 0.7* | 4.0 | NT | 4.5 | NT | NT | 3.0 | 3.9 | 3.9 |
| Step 4 : Solvent/Detergent Treatment | > 4.9 | > 3.7 | 5.7 | > 4.1 | 5.1 | 6.0 | NA | NA | NA |
| Cumulative Reduction of Virus (log10) | 6.2 | 18.3 | 5.7 | 12.3 | 5.1 | 6.0 | 6.7 | 8.0 | 7.4 |
| * These values are not included in the computation
of the cumulative reduction of virus since the virus clearance is within
the variability limit of the assay ( ≤ 1.0). NA Not Applicable. Solvent/detergent treatment does not affect non-lipid enveloped viruses. NT Not Tested. |
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When reconstituted with the total volume of diluent (Sterile Water for Injection, USP) supplied, this preparation contains approximately 50 mg of protein per mL (5%), of which at least 90% is gamma globulin. The product, reconstituted to 5%, contains a physiological concentration of sodium chloride (approximately 8.5 mg/mL) and has a pH of 6.8 ± 0.4. Stabilizing agents and additional components are present in the following maximum amounts for a 5% solution: 3 mg/mL Albumin (Human), 22.5 mg/mL glycine, 20 mg/mL glucose, 2 mg/mL polyethylene glycol (PEG), 1 µg/mL tri-n-butyl phosphate, 1 µg/mL octoxynol 9, and 100 µg/mL polysorbate 80. If it is necessary to prepare a 10% (100 mg/mL) solution for infusion, half the volume of diluent should be added, as described in the DOSAGE AND ADMINISTRATION. In this case, the stabilizing agents and other components will be present at double the concentrations given for the 5% solution. The manufacturing process for GAMMAGARD S/D (immune globulin) , isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. GAMMAGARD (immune globulin) S/D contains all of the IgG antibody activities which are present in the donor population. On the average, the distribution of IgG subclasses present in this product is similar to that in normal plasma.3
GAMMAGARD S/D (immune globulin) contains only trace amounts of IgA ( ≤ 2.2 µg/mL in a 5% solution). IgM is also present in trace amounts.
GAMMAGARD S/D, Immune Globulin Intravenous (Human) contains no preservative.
REFERENCES
1. Prince AM, Horowitz B, Brotman B. Sterilisation of hepatitis and HTLV-III viruses by exposure to tri-n-butyl phosphate and sodium cholate. Lancet. 1986;1:706-710.
2. Horowitz B, Wiebe ME, Lippin A, et al. Inactivation of viruses in labile blood derivatives: I. Disruption of lipid enveloped viruses by tri-n-butyl phosphate detergent combinations. Transfusion. 1985;25:516-522.
3. Unpublished data in the files of Baxter Healthcare Corporation.
GAMMAGARD S/D (immune globulin) is not indicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern (see WARNINGS).
GAMMAGARD S/D (immune globulin) is indicated for the treatment of primary immunodeficient states, such as: congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.6,7 This indication was supported by a clinical trial of 17 patients with primary immunodeficiency who received a total of 341 infusions. GAMMAGARD S/D (immune globulin) is especially useful when high levels or rapid elevation of circulating IgG are desired or when intramuscular injections are contraindicated (e.g., small muscle mass).
GAMMAGARD S/D (immune globulin) is indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell Chronic Lymphocytic Leukemia (CLL). In a study of 81 patients, 41 of whom were treated with GAMMAGARD, Immune Globulin Intravenous (Human), bacterial infections were significantly reduced in the treatment group.8,9 In this study, the placebo group had approximately twice as many bacterial infections as the IGIV group. The median time to first bacterial infection for the IGIV group was greater than 365 days. By contrast, the time to first bacterial infection in the placebo group was 192 days. The number of viral and fungal infections, which were for the most part minor, was not statistically different between the two groups.
When a rapid rise in platelet count is needed to prevent and/or to control bleeding in a patient with Idiopathic Thrombocytopenic Purpura, the administration of GAMMAGARD S/D (immune globulin) , should be considered.
The efficacy of GAMMAGARD (immune globulin) has been demonstrated in a clinical study involving 16 patients. Of these 16 patients, 13 had chronic ITP (11 adults, 2 children), and 3 patients had acute ITP (one adult, 2 children). All 16 patients (100%) demonstrated a clinically significant rise in platelet count to a level greater than 40,000/mm3 following the administration of GAMMAGARD (immune globulin) . Ten of the 16 patients (62.5%) exhibited a significant rise to greater than 80,000 platelets/ mm3. Of these 10 patients, 7 had chronic ITP (5 adults, 2 children), and 3 patients had acute ITP (one adult, 2 children).
The rise in platelet count to greater than 40,000/mm3 occurred after a single 1 g/kg infusion of GAMMAGARD (immune globulin) in 8 patients with chronic ITP (6 adults, 2 children), and in 2 patients with acute ITP (one adult, one child). A similar response was observed after two 1 g/kg infusions in 3 adult patients with chronic ITP, and one child with acute ITP. The remaining 2 adult patients with chronic ITP received more than two 1 g/kg infusions before achieving a platelet count greater than 40,000/mm3. The rise in platelet count was generally rapid, occurring within 5 days. However, this rise was transient and not considered curative. Platelet count rises lasted 2 to 3 weeks, with a range of 12 days to 6 months. It should be noted that childhood ITP may resolve spontaneously without treatment.
GAMMAGARD S/D (immune globulin) , is indicated for the prevention of coronary artery aneurysms associated with Kawasaki syndrome. The percentage incidence of coronary artery aneurysm in patients with Kawasaki syndrome receiving GAMMAGARD (immune globulin) either at a single dose of 1 g/kg (n=22) or at a dose of 400 mg/kg for four consecutive days (n=22), beginning within seven days of onset of fever, was 3/44 (6.8%). This was significantly different (p=0.008) from a comparable group of patients that received aspirin only in previous trials and of whom 42/185 (22.7%) experienced coronary artery aneurysms.10,11,12 All patients in the GAMMAGARD (immune globulin) trial received concomitant aspirin therapy and none experienced hypersensitivity-type reactions (urticaria, bronchospasm or generalized anaphylaxis).13 Several studies have documented the efficacy of intravenous gammaglobulin in reducing the incidence of coronary artery abnormalities resulting from Kawasaki syndrome.10-12, 14-17
For patients with primary immunodeficiencies, monthly doses of approximately 300-600 mg/kg infused at 3 to 4 week intervals are commonly used.42,43 As there are significant differences in the half-life of IgG among patients with primary immunodeficiency, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response. The minimum serum concentration of IgG necessary for protection varies among patients and has not been established by controlled clinical trials
