GAMMAPLEX- human immunoglobulin g solution

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:

Bio Products Laboratory Limited

INN (International Name):

HUMAN IMMUNOGLOBULIN G

Composition:

HUMAN IMMUNOGLOBULIN G 5 g in 50 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

GAMMAPLEX 10% is an Immune Globulin Intravenous (Human), 10% Liquid indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. GAMMAPLEX 10% is indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) in adults to raise platelet counts. - GAMMAPLEX 10% is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin - GAMMAPLEX 10% is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity Risk Summary Animal reproduction studies have not been conducted with GAMMAPLEX 10%. It is also not known whether GAMMAPLEX 10% can cause fetal harm when administered to a pregnant woman or can af

Product summary:

GAMMAPLEX 10% is supplied in a single use, clear Type II glass bottle, closed with a stopper and oversealed with a tamper-evident cap. The components used in the packaging for GAMMAPLEX 10% are not made with natural rubber latex. The following presentations of GAMMAPLEX 10% are available: Each vial has a label with a peel-off strip showing the product name and batch number. When stored between 2°C [35.6°F] and 25°C [77°F]), GAMMAPLEX 10% has a shelf life of 36 months. Keep GAMMAPLEX 10% in its original carton to protect it from light. Do not shake. Do not use GAMMAPLEX 10% beyond the expiration date on the product label. Do not freeze.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

GAMMAPLEX- HUMAN IMMUNOGLOBULIN G SOLUTION
BIO PRODUCTS LABORATORY LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GAMMAPLEX 10% SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GAMMAPLEX 10%.
GAMMAPLEX 10% IMMUNE GLOBULIN INTRAVENOUS [HUMAN], 10% LIQUID
INITIAL U.S. APPROVAL: 2017
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN PRODUCTS, INCLUDING
GAMMAPLEX 10%.
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
(5.2)
RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROSIS, AND DEATH
MAY OCCUR IN
PREDISPOSED PATIENTS WITH IMMUNE GLOBULIN INTRAVENOUS (LGIV) PRODUCTS,
INCLUDING
GAMMAPLEX 10%
RENAL DYSFUNCTION AND ACUTE RENAL FAILURE OCCUR MORE COMMONLY WITH
IGIV PRODUCTS
CONTAINING SUCROSE. GAMMAPLEX 10% DOES NOT CONTAIN SUCROSE (5.1)
FOR PATIENTS AT RISK OF THROMBOSIS, RENAL DYSFUNCTION OR ACUTE RENAL
FAILURE,
ADMINISTER GAMMAPLEX 10% 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
FOR
HYPERVISCOSITY (2.3, 5.2)
INDICATIONS AND USAGE
GAMMAPLEX 10% is an Immune Globulin Intravenous (Human) 10% Liquid
indicated for the treatment of:
primary humoral immunodeficiency (PI) in adults and pediatric patients
2 years of age and older (1.1)
chronic immune thrombocytopenic purpura (ITP) in adults (1.2)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY
INDICATION
DOSE
INITIAL INFUSION RATE
MAINTENANCE INFUSION RATE
(IF TOLERATED)
PI
300-800 mg/kg (3-8
mL/kg) every 3-4 weeks
0.5 mg/kg/min (0.005
mL/kg/min) for 15
minutes
Increase gradually every 15
minutes to 8 mg/kg/min (0.08
mL/kg/min)
IT