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Gammagard

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Gammagard

GAMMAGARD S/D
Immune Globulin Intravenous (Human)

SOLVENT DETERGENT TREATED

DRUG DESCRIPTION

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.

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.

What are the possible side effects of immune globulin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • swelling, weight gain, feeling short of breath;
  • wheezing, chest tightness;
  • feeling like you might pass out;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum),...

Read All Potential Side Effects and See Pictures of Gammagard »

What are the precautions when taking immune globulin (Gammagard)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).

Some immune globulin products should not be used in people who have a...

Read All Potential Precautions of Gammagard »

REFERENCES

What are the possible side effects of immune globulin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • swelling, weight gain, feeling short of breath;
  • wheezing, chest tightness;
  • feeling like you might pass out;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum),...

Read All Potential Side Effects and See Pictures of Gammagard »

What are the precautions when taking immune globulin (Gammagard)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).

Some immune globulin products should not be used in people who have a...

Read All Potential Precautions of Gammagard »

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.

What are the possible side effects of immune globulin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • swelling, weight gain, feeling short of breath;
  • wheezing, chest tightness;
  • feeling like you might pass out;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum),...

Read All Potential Side Effects and See Pictures of Gammagard »

What are the precautions when taking immune globulin (Gammagard)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).

Some immune globulin products should not be used in people who have a...

Read All Potential Precautions of Gammagard »

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.

What are the possible side effects of immune globulin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • swelling, weight gain, feeling short of breath;
  • wheezing, chest tightness;
  • feeling like you might pass out;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum),...

Read All Potential Side Effects and See Pictures of Gammagard »

What are the precautions when taking immune globulin (Gammagard)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).

Some immune globulin products should not be used in people who have a...

Read All Potential Precautions of Gammagard »

3. Unpublished data in the files of Baxter Healthcare Corporation.

What are the possible side effects of immune globulin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • swelling, weight gain, feeling short of breath;
  • wheezing, chest tightness;
  • feeling like you might pass out;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum),...

Read All Potential Side Effects and See Pictures of Gammagard »

What are the precautions when taking immune globulin (Gammagard)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).

Some immune globulin products should not be used in people who have a...

Read All Potential Precautions of Gammagard »

Last reviewed on RxList: 9/8/2008
This monograph has been modified to include the generic and brand name in many instances.

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