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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Gammagard Liquid (Immunoglobulin (Human))

Brand

Gammagard Liquid (Immunoglobulin (Human))

Prescription Required

Strength
Qty
10% with 5g protein
10% with 10g protein
10% with 20g protein
10% with 30g protein

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  • Product Details

    Description

    Gammagard Liquid (Immunoglobulin [Human]) is a sterile, ready-to-use solution of polyvalent human immunoglobulin G (IgG) derived from pooled plasma of healthy donors. It is indicated for the treatment of primary immunodeficiency (PI) in patients two years of age and older, as well as chronic immune thrombocytopenic purpura (ITP) in adults. Gammagard Liquid supports immune function by providing passive immunity, supplementing deficient or dysfunctional antibody production. This product is available in various concentrations and is administered intravenously or subcutaneously, depending on the clinical indication and patient-specific factors. Gammagard Liquid is manufactured using a rigorous purification process and includes steps to inactivate and remove viruses, ensuring product safety and efficacy.

    Fact Table

    Formula

    Variable (IgG is a glycoprotein)

    License

    US FDA

    Bioavailability

    100% (IV), ~73–89% (SubQ)

    Legal status

    Prescription only

    Chemical Name

    Immunoglobulin G (Human)

    Elimination half-life

    21–28 days

    Dosage (Strength)

    10% solution (100 mg/mL)

    Pregnancy

    Use only if clearly needed

    Brands

    Gammagard Liquid

    Protein binding

    >95% (plasma proteins)

    PubChem CID

    Not applicable (mixture of antibodies)

    MedlinePlus

    a605030

    ChEBI

    3824

    ATC code

    J06BA02

    DrugBank

    DB00028

    KEGG

    D01934

    Routes of administration

    Intravenous (IV), Subcutaneous (SubQ)

    Directions

    Gammagard Liquid should be administered under the supervision of a healthcare provider experienced in immunoglobulin therapy. Dosage and administration route (IV or subcutaneous) are determined by the indication, body weight, and clinical response. For PI, subcutaneous infusions are typically administered weekly, while IV administration may occur every 3 to 4 weeks. In the treatment of ITP, intravenous dosing is usually given as a high dose over 1 to 2 days. Patients must be monitored for infusion-related reactions, especially during the initial infusion or when switching brands. The product should be brought to room temperature before administration and inspected for particulate matter and discoloration.

    Ingredients

    Gammagard Liquid contains Immunoglobulin G (IgG) at a concentration of either 10% (100 mg/mL) or 5% (50 mg/mL), along with stabilizers such as glycine. The formulation is preservative-free, isotonic, and has a pH of approximately 4.6. No sucrose, maltose, or sodium is included in the formulation, reducing the risk of renal complications and thrombotic events.

    Contraindications

    Gammagard Liquid is contraindicated in individuals with a history of anaphylactic or severe systemic reactions to human immunoglobulin. It is also contraindicated in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity to immunoglobulin therapy. Use caution in patients with known hypersensitivity to glycine or other components of the formulation.

    Cautions

    Patients should be evaluated for risk factors associated with thromboembolic events, renal impairment, and aseptic meningitis prior to treatment. Adequate hydration should be ensured before administration to minimize renal risk, particularly in patients with preexisting renal disease, diabetes mellitus, or those receiving nephrotoxic drugs. Infusion rates should be adjusted based on tolerance, and patients should be monitored closely during administration. Immunoglobulin therapy may interfere with the efficacy of live attenuated vaccines; vaccination schedules may need to be adjusted accordingly. Hemolysis and hemolytic anemia have been reported and should be considered in cases of unexplained anemia following infusion.

    Side Effects

    Common and potentially serious side effects of Gammagard Liquid include:

    • Headache
    • Fatigue
    • Fever
    • Nausea
    • Chills
    • Myalgia
    • Back pain
    • Hypertension or hypotension
    • Infusion site reactions (e.g., erythema, swelling, itching for subcutaneous use)
    • Thrombotic events
    • Aseptic meningitis
    • Hemolytic anemia
    • Renal dysfunction or acute renal failure (rare)

    Immediate discontinuation and appropriate medical treatment should be considered if severe hypersensitivity or anaphylactic reactions occur.

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 15321

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