OCTAGAM IMMUNE GLOBULIN (HUMAN)- immune globulin solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Octapharma USA Inc

INN (mednarodno ime):

HUMAN IMMUNOGLOBULIN G

Sestava:

HUMAN IMMUNOGLOBULIN G 50 mg in 1 mL

Pot uporabe:

Intravenous

Terapevtske indikacije:

Octagam is an immune globulin intravenous (human) 5% liquid indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies. Octagam 5% liquid is contraindicated - in patients who have acute severe hypersensitivity reactions to human immunoglobulin. - in IgA deficient patients with antibodies against IgA and history of hypersensitivity. Octagam 5% liquid contains trace amounts of IgA (not more than 0.2 mg/mL in a 5% solution). (See Description [ 11 ]) - in patients with acute hypersensitivity reaction to corn. Octagam 5% liquid contains maltose, a disaccharide sugar that is derived from corn. Patients known to have corn allergies should avoid using Octagam 5% liquid. Risk Summary No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with Octagam 5% liquid

Povzetek izdelek:

Octagam 5% liquid is supplied in 1.0 g, 2.5 g, 5 g, 10 g or 25 g single use bottles.

Status dovoljenje:

Biologic Licensing Application

Lastnosti izdelka

OCTAGAM IMMUNE GLOBULIN (HUMAN)- IMMUNE GLOBULIN SOLUTION
OCTAPHARMA USA INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OCTAGAM, IMMUNE
GLOBULIN INTRAVENOUS (HUMAN), SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
OCTAGAM.
OCTAGAM [IMMUNE GLOBULIN INTRAVENOUS (HUMAN)]
5% LIQUID PREPARATION
INITIAL U.S. APPROVAL: 2004
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN INTRAVENOUS (IGIV) PRODUCTS,
INCLUDING
OCTAGAM 5% LIQUID. 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.
RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROSIS, AND DEATH
MAY OCCUR IN
PREDISPOSED PATIENTS WITH IGIV PRODUCTS, INCLUDING OCTAGAM 5% LIQUID.
RENAL
DYSFUNCTION AND ACUTE RENAL FAILURE OCCUR MORE COMMONLY WITH IGIV
PRODUCTS
CONTAINING SUCROSE. OCTAGAM 5% LIQUID DOES NOT CONTAIN SUCROSE.
FOR PATIENTS AT RISK OF THROMBOSIS, RENAL DYSFUNCTION OR ACUTE RENAL
FAILURE ADMINISTER
OCTAGAM 5% LIQUID 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.
INDICATIONS AND USAGE
Octagam is an immune globulin intravenous (human), 5% liquid,
indicated for treatment of primary
humoral immunodeficiency (PI) ( 1 ).
DOSAGE AND ADMINISTRATION
INTRAVENOUS USE ONLY ( 2 ).
Indication Dose
Initial Infusion rate Maintenance infusion rate (if tolerated)
PI
300-600 mg/kgEvery 3-4 weeks 0.5 mg/kg/min
3.33 mg/kg/min
• Ensure that patients with pre-existing renal insufficiency are not
volume depleted; discontinue Octagam
5% liquid if renal function deteriorates ( 2.3 ).
• For patients at risk of renal dysfunction or