Generic name: Human Immunoglobulin G 0.5g in 10mL
Dosage form: injection
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The usual dose of Flebogamma® 5% for replacement therapy in primary humoral immunodeficiency diseases is 300 to 600 mg/kg body weight administered every 3 to 4 weeks. Doses may be adjusted over time to achieve the desired trough IgG levels and clinical responses. No randomized controlled trial data are available to determine an optimum target trough serum IgG level.
The infusion of Flebogamma® 5% should be initiated at a rate of 0.01 mL/kg body weight/minute (0.5 mg/kg/minute). If, during the first 30 minutes, the patient does not experience any discomfort, the rate may be gradually increased to a maximum of 0.10 mL/kg/minute (5 mg/kg/minute).
For patients judged to be at risk for developing renal dysfunction, it may be prudent to limit the amount of product infused per unit time by infusing Flebogamma® 5% at a maximum rate less than 0.06 mL/kg body weight/minute (3 mg/kg/minute). No prospective data are available to identify a maximum safe dose, concentration, and rate of infusion in patients determined to be at increased risk of acute renal failure. In the absence of prospective data, recommended doses should not be exceeded, and the concentration and infusion rate should be the minimum level practicable. Reduction in dose, concentration, and/or rate of infusion in patients at risk of acute renal failure, which includes patients over 65 [See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS] has been proposed in the literature in order to reduce the risk of acute renal failure (22).
Flebogamma® 5% should be inspected visually for particulate matter and color prior to administration, if particles are detected the vial shall not be used. Do not use if turbid. If large doses are to be administered, several vials of Flebogamma® 5% may be pooled into an empty sterile IV solution container by using aseptic technique. Dilution with IV fluids is not recommended. An in-line filter with a pore size of 15 to 20 microns is recommended for the infusion. Antibacterial filters (0.2 micron) may also be used, although they may slow infusions. Discard unused contents and administration devices after use.
Specific drug interactions and incompatibilities have not been studied. Flebogamma® 5% should be infused through a separate intravenous line. Do not add any medications or IV fluids to the Flebogamma® 5% infusion container. Do not mix IGIV products of different formulations or from different manufacturers.