GAMMAGARD S/D [Immune Globulin Intravenous (Human)], IgA less than 1 μg/mL in a 5% solution1
Shire offers GAMMAGARD S/D treatment with IgA less than 1 μg/mL in a 5% solution.
GAMMAGARD S/D is indicated for the treatment of primary immunodeficiency (PI) associated with defects in humoral immunity, in adults and pediatric patients two years of age or older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
GAMMAGARD S/D is also indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell CLL, for the treatment of adult patients with chronic ITP to increase platelet count and to prevent and/or to control bleeding, and for the prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients.
SELECTED IMPORTANT RISK INFORMATION
WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE
- Thrombosis may occur with immune globulin products, including GAMMAGARD S/D. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products, including GAMMAGARD S/D. Renal dysfunction and acute failure occur more commonly with IGIV products containing sucrose. GAMMAGARD S/D does not contain sucrose.
- For patients at risk of thrombosis, administer GAMMAGARD S/D at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
- GAMMAGARD S/D is contraindicated in patients who have a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of GAMMAGARD S/D with <1 µg/mL IgA in a 5% solution.
Please see below for Important Risk Information. Click here to see GAMMAGARD S/D Full Prescribing Information.
Reference: 1. GAMMAGARD S/D [Immune Globulin Intravenous (Human)] IgA less than 1 μg/mL in a 5% solution [Prescribing Information]. Westlake Village, CA: Baxalta US Inc. April 2014.
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