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Features of
GAMMAGARD LIQUID Therapy

GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% is the most widely used 10% IVIG.1†

†Based on the number of grams distributed in the US, Jan-Dec 2008.

GAMMAGARD LIQUID therapy is a specially formulated 10% IVIG therapy with demonstrated efficacy, safety, and tolerability for patients – children to adults* – with primary immunodeficiency.2,3

*Clinical study evaluated patients 6-72 years of age.

Tolerability

GAMMAGARD LIQUID therapy is formulated to address a wide range of patient needs and to help tolerability.

Efficacy

In a pivotal open-label clinical study of 61 patients (58 evaluable) with primary immunodeficiency treated with 300-600 mg/kg GAMMAGARD LIQUID therapy every 21 to 28 days over a 12 month period:2,3

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. IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable in at risk patients.

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.  Some viruses, such as B19V or hepatitis A, are particularly difficult to remove or inactivate.

GAMMAGARD LIQUID should only be administered intravenously.

Immediate anaphylactic and hypersensitivity reactions are a remote possibility.

IGIV products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin causing a positive direct antiglobulin reaction and, rarely, hemolysis.  Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced red blood cell sequestration.

There have been reports of noncardiogenic pulmonary edema (Transfusion Related Acute Lung Injury [TRALI]) in patients administered IGIV.

Thrombotic events have been reported in association with IGIV.  The potential risks and benefits of IGIV should be weighed against those of alternative therapies.

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

Please refer to the detailed GAMMAGARD LIQUID Important Risk Information at the bottom of this page.

Convenience

Provide efficiency and ease of use

Viral Safety

GAMMAGARD LIQUID therapy employs plasma collection processes that put safety first. This is enhanced by a dedicated 3-step viral inactivation/removal process.2

  1. Solvent/Detergent Treatment
  2. 35 nm Nanofiltration
  3. Low pH Incubation

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.

Learn more about GAMMAGARD LIQUID therapy

Visit www.GAMMAGARDLIQUID.com. Download or order this brochure for healthcare professionals.

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.

Detailed 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.

  1. The Marketing Research Bureau. The Plasma Fractions Market in the United States 2008. Orange, CT: Marketing Research Bureau, 2009.
  2. GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% package insert. Westlake Village, CA. Baxter International Inc.; October 2009.
  3. Church JA, Leibl H, Stein MR, et al, and the US-PID-IGIV 10% Study Group. Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IGIV 10%] in patients with primary immunodeficiency. Journal of Clinical Immunology. 2006;26:388-395.