| Product | Primary Uses | Product Description |
| GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% |
Primary immunodeficiency (PI) diseases Please see Important Risk Information Please see full Prescribing Information |
Ready-to-use 10% sterile, liquid preparation of highly purified and concentrated IgG antibodies |
| GAMMAGARD S/D Immune [Globulin Intravenous (Human)] |
PI diseases, B-cell chronic lymphocytic
leukemia, ITP, Kawasaki syndrome Please see Important Risk Information Please see full Prescribing Information |
Solvent/detergent treated, sterile, freeze-dried preparation of highly purified IgG |
| GAMMAGARD S/D [Immune Globulin Intravenous (Human)], IgA less than 1 μg/mL in a 5% solution |
PI diseases, B-cell chronic lymphocytic
leukemia, ITP, Kawasaki syndrome
Please see Important Risk Information Please see full Prescribing Information |
Solvent/detergent treated, sterile, freeze-dried preparation of highly purified IgG |
For additional resources, please click here.
Baxter’s GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% is a specially formulated 10 percent IVIG therapy with demonstrated efficacy, safety, and tolerability for patients— children to adults—with primary immunodeficiency.1 Gammagard therapy is supported by the GARDian program which provides continued access to people who rely on GAMMAGARD LIQUID and GAMMAGARD S/D [Immune Globulin Intravenous (Human)].when patients experience life events such as a change in physician, site of care, or residence. Along with the GARDian program, a toll-free reimbursement hotline is available to answer questions regarding insurance reimbursement and coverage. For more information and resources, visit www.immunedisease.com.
Beyond therapy, patients are connected to programs that support consistency of therapy, educational assistance, and community connection, all of which are provided by Baxter’s BioScience business.
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.
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, IVIG 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 IVIG 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 IVIG. 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.
IVIG 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 IVIG treatment. Discontinuation of IVIG 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 full Prescribing Information
Baxter’s GAMMAGARD S/D [Immune Globulin Intravenous (Human)] is a specially formulated IVIG therapy with demonstrated efficacy, safety, and tolerability for patients—children to adults—with primary immunodeficiency. GAMMAGARD therapy is supported by the GARDian program which helps provide continued access to people who rely on GAMMAGARD LIQUID and GAMMAGARD S/D [Immune Globulin Intravenous (Human)] when patients experience life events such as a change in physician, site of care, or residence. Along with the GARDian program, a toll-free reimbursement hotline is available to answer questions regarding insurance reimbursement and coverage. For more information and resources, visit www.immunedisease.com.
Beyond therapy, patients are connected to programs that support consistency of therapy, educational assistance, and community connection, all of which are provided by Baxter’s BioScience business.
GAMMAGARD S/D is indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent infections associated with B-cell CLL.1
When a rapid rise in platelet is needed to prevent/or control bleeding in a patient with ITP, the administration of GAMMAGARD S/D should be considered.1
GAMMAGARD S/D is indicated for the prevention of coronary artery aneurysms associated with Kawasaki syndrome.1
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.
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, IVIG 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 IVIG 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 IVIG treatment. Discontinuation of IVIG 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.
IVIG 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 IVIG. 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 full Prescribing Information
Baxter’s GAMMAGARD S/D IgA less than 1 µg/mL in a 5% solution [Immune Globulin Intravenous (Human)] is a specially formulated IVIG therapy with demonstrated efficacy, safety, and tolerability for patients—children to adults—with primary immunodeficiency. GAMMAGARD therapy is supported by the GARDian program, which helps provide continued access to people who rely on GAMMAGARD LIQUID and GAMMAGARD S/D [Immune Globulin Intravenous (Human)].when patients experience life events such as a change in physician, site of care, or residence. Along with the GARDian program, a toll-free reimbursement hotline is available to answer questions regarding insurance reimbursement and coverage. For more information and resources, visit www.immunedisease.com.
Beyond therapy, patients are connected to programs that support consistency of therapy, educational assistance, and community connection, all of which are provided by Baxter’s BioScience business.
GAMMAGARD S/D is indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent infections associated with B-cell CLL.1
When a rapid rise in platelet is needed to prevent/or control bleeding in a patient with ITP, the administration of GAMMAGARD S/D should be considered.1
GAMMAGARD S/D is indicated for the prevention of coronary artery aneurysms associated with Kawasaki syndrome.1
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.
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, IVIG 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 IVIG 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. IVIG 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 IVIG preparations with higher IgA concentrations. However, the concentration of IgA that will not provoke a reaction is not known, and therefore all IVIG 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 IVIG treatment. Discontinuation of IVIG 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.
IVIG 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 IVIG. 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 full Prescribing Information
