GAMMAGARD S/D human immunoglobulin

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 ug in 1 mL

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

GAMMAGARD S/D- HUMAN IMMUNOGLOBULIN G
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 1 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_
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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:
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DOSAGE AND ADMINISTRATION
INTRAVENOUS USE ONLY
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INDIC ATIO N
RECOMMENDED DOSAGE
DURATIO N
PI (2.1)
300-600 mg/kg
Every 3 to 4 weeks
CLL (2.2)
400 mg/kg
Every 3 to 4 weeks
ITP (2.3)
1g/kg
Maximal 3 doses on alternate days
Kawasaki Syndrome (2.4)
Single 1g/kg or 400 mg/kg for 4 consecutive
days
Begin within 7 days of onset of fever
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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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)
Treatment of prim