Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 25 April 2017
• Anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human) (4)
• IgA deficient patients with antibodies against IgA and a history of hypersensitivity (4)
Warning: RENAL DYSFUNCTION & ACUTE RENAL FAILURE
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)
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.
|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
|Infusion rate may be advanced if tolerated to 5.4 mL/kg/hr (9 mg/kg/min)|
|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)
• 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)
|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|