GAMMAGARD LIQUID supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. GAMMAGARD LIQUID also contains a spectrum of antibodies capable of interacting with and altering the activity of cells of the immune system as well as antibodies capable of reacting with cells such as erythrocytes. The role of these antibodies and the mechanism of action of IgG in GAMMAGARD LIQUID have not been fully elucidated.

The mechanism of action of immunoglobulins in the treatment of CIDP in adults has not been fully elucidated but may include immunomodulatory effects.

GAMMAGARD LIQUID is an immune globulin infusion (human) indicated as a:

• Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.
• Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).
• Therapy to improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). 

Limitations of Use:

• Safety and effectiveness of GAMMAGARD LIQUID has not been studied in immunoglobulin-naïve patients with CIDP.
• GAMAGARD LIQUID maintenance therapy in CIDP has not been studied beyond 6 months.

Aqueous solution containing 10% IgG (100 mg/mL).

See package insert for complete information

The most common adverse reactions observed in ≥5% of subjects were:

• PI: Intravenous Administration: Headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, oedema peripheral, pruritus, and cardiac murmur.
• Subcutaneous Administration: Infusion site (local) event, headache, fatigue, heart rate increased, pyrexia, abdominal pain upper, nausea, vomiting, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous stomatitis, migraine, oropharyngeal pain, and pain in extremity.
• MMN: Headache, chest discomfort, muscle spasms, muscular weakness, nausea, oropharyngeal pain, and pain in extremity.
• CIDP: Headache, pyrexia anemia, leukopenia, neutropenia, illness, blood creatinine increased, dizziness, migraine, somnolence, tremor, nasal dryness, abdominal pain upper, vomiting, chills, nasopharyngitis, and pain in extremity.

• Anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human).
• IgA deficient patients with antibodies against IgA and a history of hypersensitivity.

• IgA deficient patients with antibodies to IgA are at greater risk of developing severe hypersensitivity and anaphylactic reaction.
• Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of acute renal failure. 
• Hyperproteinemia, increased serum viscosity and hyponatremia may occur. 
• Thrombosis may occur. Monitor for signs and symptoms of thrombosis and assess blood viscosity for those at risk for hyperviscosity. 
• Aseptic Meningitis Syndrome (AMS) may occur. 
• Hemolytic anemia can develop. Monitor for clinical signs and symptoms of hemolysis and hemolytic anemia. 
• Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury, TRALI). 
• GAMMAGARD LIQUID is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the CreutzfeldtJakob disease agent.