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GAMMAGARD Therapies
Clinical Questions

1. What is the pH of GAMMAGARD LIQUID therapy?1,2

GAMMAGARD LIQUID therapy has a pH of 4.6 to 5.1. Studies have shown that low-pH IVIG preparations are rapidly neutralized by blood. When a low pH solution enters the vein, the blood dilutes and reduces the acidity of the solution to a tolerable level.

2. What is osmolality? 1,2

The term osmolality is used to describe the number of particles in a solution, or solute concentration. Osmolality is the concentration of a solution expressed in osmoles of solute particles per kilogram of solvent (mOsmol/kg). The osmolality of GAMMAGARD LIQUID therapy is 240-300 mOsmol/kg, which is similar to physiological osmolality of 285 to 295 mOsmol/kg.

3. Why is the rate of infusion important to consider?1,3,4

The rate of infusion is an important variable that could influence the occurrence of adverse reactions. A rate of administration that is too rapid may cause flushing and changes in pulse rate and blood pressure. Slowing or stopping the infusion usually results in the prompt disappearance of signs. The infusion may then be resumed at a rate that is comfortable for the patient.

Patients who have underlying renal disease or who are judged to be at risk of developing thrombotic events should not be infused rapidly with any IVIG products.

4. What is the recommended rate of infusion when giving a patient GAMMAGARD LIQUID therapy for the first time? 1

During the clinical study, GAMMAGARD LIQUID therapy was infused at the initial rate of 0.5 mL/kg/hour (0.8 mg/kg/minute). The rate was gradually increased every 30 minutes to a rate of 5 mL/kg/hour (8.9 mg/kg/minute) if it was well tolerated. It is recommended that patients who are judged to be at risk of renal dysfunction or thrombotic complications be gradually titrated to a more conservative maximal rate of less than 3.3mg IgG/kg/minute (2 mL/kg/hour).

5. Is there any information regarding the rate of administration for patients switching from GAMMAGARD S/D [Immune Globulin Intravenous (Human)] to GAMMAGARD LIQUID therapy? 1

In general, it is recommended that patients beginning IVIG therapy or switching from one IVIG product to another be started at the lower rates and then advanced to the maximal rate if they have tolerated several infusions at intermediate rates of infusion. It is important to individualize rates for each patient. For more information, contact Medical Information at 866-424-6724.

6. Can GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% be diluted to a 5% concentration?1

GAMMAGARD LIQUID therapy is available as a 10% solution. If dilution is preferred, GAMMAGARD LIQUID therapy may be diluted with 5% dextrose in water (D5W). Normal saline (NS) should not be used as a diluent.

7. How should GAMMAGARD LIQUID therapy be stored?1

GAMMAGARD LIQUID therapy can be stored for 36 months at refrigerated temperature 2° - 8° C (36° - 46° F) or for 12 months at room temperature 25°C (77°F) within the first 24 months of the date of processing. After 24 months from date of manufacture, the product cannot be stored at room temperature. The new expiration date must be recorded on the package when the product is transferred to room temperature. Do not freeze.

8. Is using an administration set with a filter required for infusion of GAMMAGARD LIQUID therapy?1

The use of an in-line filter is optional. GAMMAGARD LIQUID therapy is not supplied with an administration set.

9. Will GAMMAGARD S/D therapy still be available for patients with IgA sensitivity?

Baxter will continue to provide GAMMAGARD S/D therapy for patients who require a low IgA content in their IVIG therapy.

In order to simplify the process for patients, as well as healthcare providers and pharmacists like you, we no longer require an application for access to GAMMAGARD S/D therapy with IgA < 1µg/mL in a 5% solution. Moving forward, please call Baxter Customer Service at 1-800-423-2090 to place your orders as you do for other BioScience products.

GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10%

GAMMAGARD LIQUID is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Important Risk Information for GAMMAGARD LIQUID

GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number.

Glycine, an amino acid, is used as a stabilizer. GAMMAGARD LIQUID does not contain sucrose.

GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Components used in the packaging of this product are latex-free.

Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.

IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.

Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

Various mild and moderate reactions, such as headache, fever, fatigue, chills, flushing, dizziness, urticaria, wheezing or chest tightness, nausea, vomiting, rigors, back pain, chest pain, muscle cramps, and changes in blood pressure may occur with infusions of Immune Globulin Intravenous (Human).

Please see the Full Prescribing Information for GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] for full prescribing details.

GAMMAGARD S/D [Immune Globulin Intravenous (Human)]

GAMMAGARD S/D is indicated for the treatment of primary immunodeficient states, such as: congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

GAMMAGARD S/D is not indicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern. See Warnings section of full Prescribing Information for important risk information.

Important Risk Information for GAMMAGARD S/D

Patients may experience severe hypersensitivity reactions or anaphylaxis in the setting of detectable IgA levels following infusion of GAMMAGARD S/D.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number.

GAMMAGARD S/D does not contain sucrose.

GAMMAGARD S/D is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

Certain components used in the packaging of GAMMAGARD S/D contain natural rubber latex.

IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.

Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.

Various minor reactions, such as mild to moderate hypotension, headache, fatigue, chills, backache, leg cramps, lightheadedness, fever, urticaria, flushing, slight elevation of blood pressure, nausea and vomiting, may occasionally occur.

Please see the Full Prescribing Information for GAMMAGARD S/D [Immune Globulin Intravenous (Human)] for full prescribing details.

GAMMAGARD S/D [Immune Globulin Intravenous (Human)], IgA less than 1 μg/mL in a 5% solution

GAMMAGARD S/D is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

GAMMAGARD S/D must not be used in patients with selective IgA deficiency (IgA < 0.05 g/L) where the IgA deficiency is the only abnormality of concern.

Important Risk Information for GAMMAGARD S/D, IgA less than 1µg/mL in a 5% solution

Patients may experience severe hypersensitivity reactions or anaphylaxis in the setting of detectable IgA levels following infusion of GAMMAGARD S/D.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number.

GAMMAGARD S/D does not contain sucrose.

GAMMAGARD S/D, IgA < 1 μg/mL, has a lower IgA concentration than GAMMAGARD S/D which has a concentration of 1 to 2.2 μg/mL. IGIV preparations depleted of IgA (0.4 to 2.9 μg/mL) were shown to be better tolerated by a limited number of patients who reacted to IGIV preparations with higher IgA concentrations. However, the concentration of IgA that will not provoke a reaction is not known, and therefore all IGIV preparations carry the risk of inducing an anaphylactic reaction to IgA. In such instances, a risk of anaphylaxis may exist despite the fact that GAMMAGARD S/D, IgA < 1 μg/mL, contains trace amounts of IgA.

GAMMAGARD S/D is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

Certain components used in the packaging of GAMMAGARD S/D contain natural rubber latex.

IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.

Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.

Various minor reactions, such as mild to moderate hypotension, headache, fatigue, chills, backache, leg cramps, lightheadedness, fever, urticaria, flushing, slight elevation of blood pressure, nausea and vomiting may occasionally occur.

Please see the Full Prescribing Information for GAMMAGARD S/D [Immune Globulin Intravenous (Human)], IgA less than 1 µg/mL in a 5% solution for full prescribing details.

  1. GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% package insert. Westlake Village, CA. Baxter International Inc.; October 2009.
  2. Lemm G. Composition and properties of IVIG preparations that affect tolerability and therapeutic efficacy. Neurology. 2002; 59 (6): S28-S32.
  3. Greenbaum BH. Differences in immunoglobulin preparations for intravenous use: a comparison of six products. The American Journal of Pediatric Hematology/Oncology 1990; 12(4):490-496
  4. Goldsmith JC, Sedlak DA, et al. A guide for nurses on immune globulin therapy. The Immune Deficiency Foundation Nursing Advisory Committee, 2004.