Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 25 April 2017


• GAMMAGARD LIQUID is an immune globulin infusion (human) indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older. (1.1)
• GAMMAGARD LIQUID is indicated as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy [MMN].(1.2).

Full Prescribing information

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Advisory information


• Anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human) (4)
• IgA deficient patients with antibodies against IgA and a history of hypersensitivity (4)

Special warnings and precautions

See full prescribing information for complete boxed warning
• Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Renal dysfunction and acute failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAGARD LIQUID does not contain sucrose.
• For patients at risk of renal dysfunction or failure, administer GAMMAGARD LIQUID at the minimum rate of infusion practicable.

• IgA deficient patients with antibodies to IgA are at greater risk of developing severe hypersensitivity and anaphylactic reaction. (5.1)
• Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of acute renal failure. (5.2)
• Hyperproteinemia, increased serum viscosity and hyponatremia may occur. (5.3)
• Thrombotic events may occur. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk for hyperviscosity. (5.4)
• Aseptic Meningitis Syndrome (AMS) may occur. (5.5)
• Hemolytic anemia can develop. Monitor for clinical signs and symptoms of hemolysis and hemolytic anemia. (5.6)
• Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury, TRALI). (5.7)
• Product is made from human plasma and may contain infectious agents, e.g., viruses and theoretically, Creutzfeldt-Jacob disease (CJD) agent. (5.8)

Adverse reactions

Serious adverse reactions which occurred in the clinical trials were aseptic meningitis, pulmonary embolism, and blurred vision(6.1)
The most common adverse reactions observed in ≥5% of patients were (6.1):
PI: Intravenous Administration: Headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolarynegeal pain, rash, arhralgia, 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, oropharyneal pain, and pain in extremity.
MMN: Headache, chest discomfort, muscle spasms, muscular weakness, nausea, oropharyneal pain, and pain in extremity.

Usage information

Dosing and administration
Dose Initial Infusion
Maintenance Infusion
Intravenous Administration
300 to 600 mg/kg every 3 to 4 weeks based on clinical response 0.5 mL/kg/hr
(0.8 mg/kg/min) for 30 minutes
Increase every 30 minutes (if tolerated) up to 5 mL/kg/hr (8 mg/kg/min)
Dose range 0.5 to 2.4 grams/kg/month based on clinical response 0.5mL/kg /hr
(0.8 mg/kg/min)
Infusion rate may be advanced if tolerated to 5.4 mL/kg/hr (9 mg/kg/min)
Subcutaneous Administration
Initial Dose is 1.37 × previous intravenous dose divided by # of weeks between intravenous doses.
Maintenance dose is based on clinical response and target IgG trough level (2.2).
40 kg BW and greater: 30 mL/site at 20 mL/hr/site.
Under 40 kg BW: 20 mL/site at 15 mL/hr/site
40 kg BW and greater: 30 mL/site at 20 to 30 mL/hr/site.
Under 40 kg BW: 20 mL/site at 15 to 20 mL/hr/site

• Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue GAMMAGARD LIQUID if renal function deteriorates. (2.3, 5.2)
• For patients at risk of renal dysfunction or thrombotic events, administer GAMMAGARD LIQUID at the minimum infusion rate practicable. (2.3, 5.2, 5.4)


Use in special populations
• Pregnancy: No human or animal data. Use only if clearly indicated. (8.1)
• Geriatric: In patients over age 65 or in any patient at risk of developing renal insufficiency, do not exceed the recommended dose, and infuse GAMMAGARD LIQUID at the minimum infusion rate practicable. (8.5)


Passive transfer of antibodies may transiently interfere with the immune responses to live virus vaccines, such as measles, mumps, rubella, and varicella. (7)

More information

Category Value
Authorisation number BLA103133
Orphan designation No
Product NDC 0944-2620; 0944-2623; 0944-2625; 0944-2627; 0944-2656; 0944-2658; 0944-2658
Date First Approved 10-05-1994
Marketing authorisation holder Baxter Healthcare Corporation