GAMMAGARD S/D- immune globulin intravenous (human)

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)

Available from:

Baxalta US Inc.

INN (International Name):

HUMAN IMMUNOGLOBULIN G

Composition:

HUMAN IMMUNOGLOBULIN G 50 mg in 1 mL

Therapeutic indications:

Primary Immunodeficiency (PI) GAMMAGARD S/D is indicated for the treatment of primary immunodeficiency (PI) associated with defects in humoral immunity, in adults and children two years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.1,2,3 B-cell Chronic Lymphocytic Leukemia (CLL) GAMMAGARD S/D is indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL).4 Idiopathic Thrombocytopenic Purpura (ITP) GAMMAGARD S/D is indicated for the treatment of adult chronic idiopathic thrombocytopenic purpura to increase platelet count and to prevent and/or to control bleeding. Kawasaki Syndrome GAMMAGARD S/D is indicated for the prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients.5 - GAMMAGARD S/D is contraindicated in patients

Product summary:

GAMMAGARD S/D is supplied in single use bottles containing the labeled amount of functionally active IgG. The following presentation of GAMMAGARD S/D is available: Each bottle of GAMMAGARD S/D is furnished with a suitable volume of Sterile Water for Injection, USP, a transfer device and an administration set which contains an integral airway and a 15 micron filter. Store GAMMAGARD S/D at a temperature not to exceed 25ºC (77ºF) for 24 months. Do not Freeze. Not made with natural rubber latex.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

GAMMAGARD S/D- IMMUNE GLOBULIN INTRAVENOUS (HUMAN)
BAXALTA US INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GAMMAGARD S/D SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR GAMMAGARD S/D
GAMMAGARD S/D, IMMUNE GLOBULIN INTRAVENOUS (HUMAN)
IGA LESS THAN OR EQUAL TO 2.2 MICROGRAM PER ML IN A 5% SOLUTION
INITIAL U.S. APPROVAL: 1994
WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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. (5.3)
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. (5.2)
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. (5.3)
RECENT MAJOR CHANGES
Warnings & Precautions, Aseptic Meningitis Syndrome (5.4)
09/2016
INDICATIONS AND USAGE
GAMMAGARD S/D is an immune globulin intravenous (Human), indicated
for:
Treatment of primary immunodeficiency (PI) in adults and pediatric
patients two years of age or older. (1)
Prevention of bacterial infections in hypogammaglobulinemia and/or
recurrent bacterial infections associated with B-cell
chronic lymphocytic leukemia (CLL). (1)
Prevention and/or control of bleeding in adult chronic idiopathic
thrombocytopenic purpura (ITP) patients. (1)
Prevention of coronary a