FLEBOGAMMA DIF (immune globulin- human injection, 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:

GRIFOLS USA, LLC

INN (International Name):

HUMAN IMMUNOGLOBULIN G

Composition:

HUMAN IMMUNOGLOBULIN G 0.05 g in 1 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

Flebogamma 5% DIF is an immune globulin intravenous (human) solution indicated in adults and pediatric patients 2 years of age and older for the treatment of primary immunodeficiency (PI), including the humoral immune defects in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and Wiskott-Aldrich syndrome. - Flebogamma 5% DIF is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin. - Flebogamma 5% DIF is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. (see Warnings and Precautions [5.1] ) Risk Summary There are no studies of Flebogamma 5% DIF use in pregnant women. Animal reproduction studies have not been performed with Flebogamma 5% DIF. It is also not known whether Flebogamma 5% DIF can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. Flebogamma 5% DIF should be given to a pregnant woman only if clearly needed. Risk Summary There is no information regarding the presence of Flebogamma 5% DIF in human milk, its effects on the breastfed infant, or its effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Flebogamma 5% DIF and any potential adverse effects on the breastfed infant from Flebogamma 5% DIF or from the underlying maternal condition. Flebogamma 5% DIF was studied in a multicenter clinical trial for the treatment of PI in 24 subjects aged 2-16 years (seven were 2-5 years of age, seven were 6-11 years, and ten were 12-16 years), and found to be efficacious for the prevention of acute serious bacterial infections. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels. Twenty subjects (83.3%) had at least one adverse reaction at some time during the study that was considered product-related. There were no deaths or serious adverse reactions. Treatment-related adverse reactions that occurred with an incidence of at least 5% on a per-subject basis included headache (42%), pyrexia (29%), hypotension (25%), tachycardia (25%), diastolic hypotension (21%), nausea (8%), abdominal pain (8%), diarrhea (8%), pain (8%), and vomiting (8%). Safety and efficacy of Flebogamma 5% DIF in pediatric patients below the age of 2 years have not been established. Limited information is available for the geriatric use of Flebogamma 5% DIF. Clinical studies of Flebogamma 5% DIF did not include sufficient numbers of subjects over the age of 65 to determine whether they respond differently from younger subjects. Use caution when administering Flebogamma 5% DIF to patients age 65 and over who are judged to be at increased risk for developing thrombosis or renal insufficiency. Do not exceed recommended dose, and administer Flebogamma 5% DIF at the minimum dose and infusion rate practicable, and at less than 0.06 mL per kg per minute (3 mg per kg per min). (see Boxed Warning, Warning and Precautions [5.2, 5.4], and Dosage and Administration [2.3] )

Product summary:

Flebogamma 5% DIF is supplied in single-use, individually laser-etched vials containing the labeled amount of functionally active IgG. The following presentations of Flebogamma 5% DIF are available: Each vial has an integral suspension band and a label with two peel-off strips showing the product name and lot number. Flebogamma 5% DIF may be stored at room temperature at 2 to 25 ºC (36 to 77 ºF) for 24 months, as indicated by the expiration date printed on the outer carton and container label. Discard after expiration date. Do not freeze. Keep Flebogamma 5% DIF in its original carton to protect it from light. Not made with natural rubber latex.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

FLEBOGAMMA DIF- IMMUNE GLOBULIN (HUMAN) INJECTION, SOLUTION
GRIFOLS USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLEBOGAMMA 5% DIF SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR FLEBOGAMMA 5% DIF.
FLEBOGAMMA 5% DIF (IMMUNE GLOBULIN INTRAVENOUS [HUMAN]), SOLUTION
FOR INTRAVENOUS ADMINISTRATION
INITIAL U.S. APPROVAL: 2006
WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL
FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN PRODUCTS, INCLUDING
FLEBOGAMMA 5%
DIF. 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.
FOR PATIENTS AT RISK OF THROMBOSIS ADMINISTER FLEBOGAMMA 5% DIF 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.
RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROSIS AND DEATH
MAY OCCUR WITH
THE ADMINISTRATION OF HUMAN IMMUNE GLOBULIN INTRAVENOUS (IGIV)
PRODUCTS,
PARTICULARLY THOSE PRODUCTS THAT CONTAIN SUCROSE. FLEBOGAMMA 5% DIF
DOES NOT
CONTAIN SUCROSE.
FOR PATIENTS AT RISK OF RENAL DYSFUNCTION OR FAILURE, ADMINISTER
FLEBOGAMMA 5% DIF
AT THE MINIMUM DOSE AND INFUSION RATE PRACTICABLE. (5.2)
RECENT MAJOR CHANGES
Dosage and Administration (2 )
9/2019
INDICATIONS AND USAGE
Flebogamma 5% DIF is an immune globulin intravenous (human), indicated
for treatment of primary
(inherited) immunodeficiency (PI) in adults and pediatric patients 2
years of age and older. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY
Indication
Dose
Initial Infusion Rate
Maintenance Dose Rate (if tolerated)
PI
300-600 mg per kg
every 3-4 weeks
0.01 mL per kg per minute
(0.5 mg per kg per min)
Increase to 0.10 mL per kg