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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.
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.
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
These types of symptoms may be due to ITP, a blood platelet disorder that affects approximately 200,000 men, women, and children in the United States.1 ITP occurs as a result of the body identifying its own platelets as foreign objects, resulting in their destruction.
ITP is rare and can be complicated to treat. That's why Baxter BioTherapeutics provides patients and caregivers with WinRho® SDF Liquid. WinRho® works by helping the body increase platelet counts, preventing excessive blood hemorrhages.2
Please visit WinRho.com today to learn more about the treatment of ITP and learn if WinRho® is right for you.
WinRho® SDF must be administered via the intravenous route when used in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in the treatment of non-splenectomized, Rho(D) positive:
The safety and efficacy of WinRho® have not been evaluated in clinical trials for patients with non-ITP causes of thrombocytopenia or in previously splenectomized patients or in patients who are Rho(D) negative.
Individuals known to have severe, potentially life-threatening reaction to human globulin should not receive WinRho® SDF or any other immune globulin (Human). Individuals who are deficient in IgA may have the potential for developing IgA antibodies and have severe, potentially life-threatening allergic reactions.
Physicians should alert the patients who are being treated with WinRho® SDF about the signs and symptoms consistent with intravascular hemolysis that include back pain, shaking chills, fever and discolored urine occurring, in most cases, within four hours of administration. Potentially serious complications of intravascular hemolysis that have also been reported include clinically compromising anemia, acute renal insufficiency or disseminated intravascular coagulation (DIC) that have, in some cases, been fatal. The extent of risk of intravascular hemolysis and its complications is not known but is reported to be rare, especially for DIC, which is very rare.
The liquid formulation of WinRho® SDF contains maltose. Maltose in lVlG products has been shown to give falsely high blood glucose levels in certain types of blood glucose testing systems. Due to the potential for falsely elevated glucose readings, only testing systems that are glucose-specific should be used to test or monitor blood glucose levels in patients receiving WinRho® SDF Liquid.
WinRho® SDF 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.
WinRho® SDF must be administered via the intravenous route for the treatment of ITP.
WinRho® SDF should not be administered to Rho(D) -negative or splenectomized individuals as its efficacy in these patients has not been demonstrated.
In Rho(D) -positive patients with ITP, side effects related to the destruction of Rho(D)-positive red blood cells, most notably a decreased hemoglobin, can be expected. In most cases, the red blood cells destruction is believed to occur in the spleen. However, signs and symptoms consistent with intravascular hemolysis (IVH), including back pain, shaking chills, and/or pink urine, have been reported. Other less common reactions include death, rapid or worsening of anemia, and rapid or worsening of kidney function.
General adverse reactions associated with the use of WinRho® SDF include body weakness, abdominal or back pain, low blood pressure, paleness, diarrhea, abnormal blood work, joint pain, muscle pain, dizziness, abnormal movement, sleepiness, itchiness, rash, and sweating. In the treatment of ITP, the most common adverse events (≤ 2% of infusions) were headache, chills, and fever.
Please see full Prescribing Information
