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GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% The efficacy of GAMMAGARD LIQUID 10% has been demonstrated in a pivotal open-label clinical study of 61 patients (58 evaluable) with primary immunodeficiency. These patients were treated with 300–600 mg/kg GAMMAGARD LIQUID every 21–28 days over 12 months. The primary efficacy endpoint of the study was the annualized rate of specified acute serious bacterial infections; there were none in any of the treated patients.1 See chart below:
Secondary efficacy endpoints included the incidence of other specified validated bacterial infections. There was one reported incidence of urinary tract infection, one of gastroenteritis, 2 of otitis media, no lower respiratory tract infections and no hospitalizations secondary to all validated infection complications. Adverse experiences included 15 serious events in 8 subjects; two events—both in a single subject—were deemed to be possibly related to the infusion of GAMMAGARD LIQUID. There were 896 non-serious adverse experiences, 258 of which were judged possibly or probably related to the infusion of GAMMAGARD LIQUID; of these 136 were mild, 106 moderate, and 16 severe—none of the 16 led to hospitalization. For the most current information on adverse event data, please see GAMMAGARD LIQUID Prescribing Information or contact Medical Affairs at 866-424-6724. GAMMAGARD LIQUID 10% contains 100 mg/mL protein, composed of at least 98% gammaglobulin, including a broad spectrum of IgG antibodies against bacterial and viral agents. 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 Safety Information 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. As with all plasma-derived therapeutics, the potential to transmit infectious agents (e.g., viruses) cannot be totally eliminated. 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. 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. IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis. Components used in the packaging of this product are latex-free. 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). Full Prescribing Information Please see Full Prescribing Information for GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10%
1. GAMMAGARD LIQUID Immune Globulin Intravenous (Human) 10% [package insert]. Deerfield, IL. Baxter International Inc.; April 2005. |
