Baxter to Launch GARDian(TM), a Groundbreaking Initiative That Helps Provide Continued Access to GAMMAGARD for Curren... (urticaria flushing slight elevation of b...)

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Baxter to Launch GARDian(TM), a Groundbreaking Initiative That Helps Provide Continued Access to GAMMAGARD for Current Patients

Date:8/22/2007

urticaria, flushing, slight elevation of blood pressure, nausea and vomiting, may occasionally occur.

GAMMAGARD S/D with IgA < 1 microgram/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 microgram/mL, has a lower IgA concentration than GAMMAGARD S/D which has a concentration of 1 to 2.2 microgram/mL. IGIV preparations depleted of IgA (0.4 to 2.9 microgram/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 microgram/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.

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Baxter to Launch GARDian(TM), a Groundbreaking Initiative That Helps Provide Continued Access to GAMMAGARD for Curren...(urticaria flushing slight elevation of b...)