GAMMAGARD LIQUID (immune globulin infusion- 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:

Takeda Pharmaceuticals America, Inc.

INN (International Name):

HUMAN IMMUNOGLOBULIN G

Composition:

HUMAN IMMUNOGLOBULIN G 100 mg in 1 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

GAMMAGARD LIQUID is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.1,2 GAMMAGARD LIQUID is indicated as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN). GAMMAGARD LIQUID is indicated as a therapy to improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Limitation of Use GAMMAGARD LIQUID has not been studied in immunoglobulin-naive patients with CIDP. GAMMAGARD LIQUID maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with GAMMAGARD LIQUID in order to remain free of CIDP symptoms. Individualize the duration of any treatment beyond 6 months based upon the patient’s response and demonstrated need for continued therapy. GAMMAGARD LIQUID is contraindicated in patients who have a history of anaphylactic or severe systemic hypersensitivity reactions to administration of human immune globulin. GAMMAGARD LIQUID is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Anaphylaxis has been reported with intravenous use of GAMMAGARD LIQUID and is theoretically possible following subcutaneous administration [see Warnings and Precautions (5.1)] . Risk Summary Animal reproduction studies have not been conducted with GAMMAGARD LIQUID. It is not known whether GAMMAGARD LIQUID can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. GAMMAGARD LIQUID should be given to a pregnant woman only if clearly indicated. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary There is no information regarding the presence of GAMMAGARD LIQUID 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 GAMMAGARD LIQUID and any potential adverse effects on the breastfed infant from GAMMAGARD LIQUID or from the underlying maternal condition. Treatment of Primary Immunodeficiency (PI) GAMMAGARD LIQUID administered intravenously was evaluated in 15 pediatric subjects with PI (7 subjects aged 2 to <12 years and 8 subjects aged 12 to <16 years) in a multicenter clinical study. GAMMAGARD LIQUID administered subcutaneously was evaluated in 18 pediatric subjects with PI (14 subjects aged 2 to <12 years and 4 subject aged 12 to <16 years) in another multicenter clinical study. The safety and efficacy profiles were similar to adult subjects. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels. Safety and efficacy of GAMMAGARD LIQUID in pediatric patients below the age of 2 have not been established. Treatment of Multifocal Motor Neuropathy (MMN) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Safety and effectiveness in pediatric patients with MMN and CIDP have not been established. Treatment of Primary Immunodeficiency (PI) Limited information is available for the geriatric use of GAMMAGARD LIQUID. GAMMAGARD LIQUID administered intravenously and subcutaneously was evaluated in two PI studies with a total of 8 subjects over the age of 65 years. No differences in safety or efficacy were observed for this group. Monitor patients who are at an increased risk for developing renal failure or thrombotic events. Do not exceed the recommended dose. Infuse at the minimum intravenous infusion rate practicable [see Boxed Warning, Warnings and Precautions (5.2, 5.4) and Dosage and Administration (2.5)] . Treatment of Multifocal Motor Neuropathy (MMN) GAMMAGARD LIQUID was administered intravenously for treatment of MMN in 5 subjects aged 65 years and above. There was an insufficient number of subjects aged 65 years and above to determine whether they respond differently from younger subjects [see Boxed Warning, Warnings and Precautions (5.2, 5.4) and Dosage and Administration (2.5)] . Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) GAMMAGARD LIQUID was administered intravenously for the treatment of CIDP in 5 subjects aged 65 years and above and 15 subjects aged below 65 years. There was an insufficient number of subjects aged 65 years and above to determine whether they respond differently from younger subjects. [see Boxed Warning, Warnings and Precautions (5.2, 5.4) and Dosage and Administration (2.5)] .

Product summary:

GAMMAGARD LIQUID is supplied in single use bottles containing the labeled amount of functionally active IgG. The packaging of this product is not made with natural rubber latex. The following presentations of GAMMAGARD LIQUID are available: NDC Number Volume Grams Protein 0944-2700-02 10 mL 1.0 0944-2700-03 25 mL 2.5 0944-2700-04 50 mL 5.0 0944-2700-05 100 mL 10.0 0944-2700-06 200 mL 20.0 0944-2700-07 300 mL 30.0

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

GAMMAGARD LIQUID- IMMUNE GLOBULIN INFUSION (HUMAN) INJECTION, SOLUTION
TAKEDA PHARMACEUTICALS AMERICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GAMMAGARD LIQUID
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GAMMAGARD
LIQUID.
GAMMAGARD LIQUID, IMMUNE GLOBULIN INFUSION (HUMAN), 10% SOLUTION, FOR
INTRAVENOUS AND
SUBCUTANEOUS ADMINISTRATION
INITIAL U.S. APPROVAL: 2005
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
▪ Indications and Usage (1.3)
1/2024
▪ Dosage and Administration (2.3)
1/2024
INDICATIONS AND USAGE
GAMMAGARD LIQUID is an immune globulin infusion (human) indicated as
a:
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Limitations of Use:
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DOSAGE AND ADMINISTRATION
PI: _Intravenous (IV)_ (2.1)
DOSE
INITIAL INFUSION RATE
MAINTENANCE INFUSION RATE
300 to 600 milligram (mg)/kg every 3
to 4 weeks based on clinical
response
0.5milliliter (mL)/kg/hr
(0.8 mg/kg/min) for 30 minutes
Increase every 30minutes (if
tolerated) up to 5 mL/kg/hr (8
mg/kg/min)
THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN PRODUCTS, INCLUDING
GAMMAGARD
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. (5.4)
RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROSIS, AND DEATH
MAY OCCUR IN
PREDISPOSED PATIENTS WITH IMMUNE GLOBULIN INTRAVENOUS (IGIV) PRODUCTS
INCLUDING
GAMMAGARD LIQUID. RENAL DYSFUNCTION AND ACUTE FAILURE OCCUR MORE
COMMONLY
WITH IGIV PRODUCTS CONTAINING SUCROSE. GAMMAGARD LIQUID DOES NOT
CONTAIN
SUCROSE. (5.2)
FOR PATIENTS AT RISK OF THROMBOSIS, ADMINISTER GAMMAGARD 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