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:
- Hypertension or hypotension
- Infusion site reactions (e.g., erythema, swelling, itching for subcutaneous use)
- 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