Flebogamma® 5% DIF
Immune Globulin Intravenous (Human), 5%
Highly purified, unmodified, 5% concentration human IgG solution
- Indications: Replacement therapy in primary (inherited) humoral immunodeficiency disorders, such as common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and Wiskott-Aldrich Syndrome
- Broad Safety Margin:
- High purity 5 % concentration immune globulin
- Trace amounts of IgA
- Stabilized with sorbitol
- Sucrose and maltose free
- Very low sodium content
- Liquid: Ready to use. No need for reconstitution
- Dosing flexibility: 4 vial sizes available, including a 20 g vial
|Fill Size||Grams Protein||NDC Number|
|50 mL||2.5 g||61953-0004-2|
|100 mL||5 g||61953-0004-3|
|200 mL||10 g||61953-0004-4|
|400 mL||20 g||61953-0004-5|
- Room temperature storage for the entire 2 year shelf life
- Between +2 ºC and +25 ºC (36 to 77 ºF) up to 2 years
- Do not freeze
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IMPORTANT SAFETY INFORMATION:
Flebogamma® 5% DIF is an immune globulin intravenous (human) 5% preparation that is indicated for the treatment of primary immunodeficiency disease (PIDD), including the humoral immune defect in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and Wiskott-Aldrich syndrome.
Thrombosis may occur with immune globulin products, including Flebogamma 5% DIF. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer Flebogamma 5% DIF at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death have been related to intravenous immune globulin (IVIG) products. Patients predisposed to acute renal failure include patients with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Administer Flebogamma 5% DIF at the minimum rate of infusion practicable in patients at risk for renal dysfunction or failure. Reports of renal dysfunction and acute renal failure occur more commonly in patients receiving IVIG products containing sucrose as a stabilizer. They account for a disproportionate share of the total number of reported cases of renal dysfunction and acute renal failure. Flebogamma 5% DIF does not contain sucrose.
Flebogamma 5% DIF is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
Severe hypersensitivity reactions may occur with IVIG products, including Flebogamma 5% DIF. In case of hypersensitivity, discontinue Flebogamma 5% DIF infusion immediately and institute appropriate treatment.
Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output in patients at risk of developing acute renal failure.
Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving Flebogamma 5% DIF therapy.
Aseptic meningitis syndrome (AMS) has been reported to occur following IVIG treatment. AMS may occur more frequently following high dose (eg > 1.0 g/kg body weight) and/or rapid infusion of IVIG.
Hemolytic anemia can develop subsequent to IVIG therapy, including Flebogamma 5% DIF. Flebogamma 5% DIF contains blood group antibodies, which may act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and hemolysis. If signs and/or symptoms of hemolysis are present after an infusion of Flebogamma 5% DIF, perform appropriate laboratory testing for confirmation.
Noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) has been reported in patients following IVIG treatment. If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies and anti-HLA antibodies in both the product and patient serum.
Individuals receiving Flebogamma 5% DIF for the first time or being restarted on the product after a treatment hiatus of more than 8 weeks may be at a higher risk for the development of fever, chills, nausea, and vomiting. Careful monitoring of recipients and adherence to recommendations regarding dosage and administration may reduce the risk of these types of events.
Because Flebogamma 5% DIF is made from human plasma, it may carry a risk of transmitting infectious agents, eg, viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also applies to unknown or emerging viruses and other pathogens. No cases of transmission of viral diseases or CJD have been associated with the use of Flebogamma 5% DIF.
Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of BUN and serum creatinine, before the initial infusion of Flebogamma 5% DIF and at appropriate intervals thereafter.
Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies, because of the potentially increased risk of thrombosis.
If signs and/or symptoms of hemolysis are present after an infusion of Flebogamma 5% DIF, perform appropriate laboratory testing for confirmation.
If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies and anti-HLA antibodies in both the product and patient's serum. After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation.
In the preapproval clinical trial, the most common adverse reactions (reported in ≥ 5% of clinical trial subjects) were: headache, pyrexia/fever, pain, infusion-site reactions, diarrhea, rigors or chills, urticaria, and infusion-site inflammation.
Please see accompanying Flebogamma 5% DIF full Prescribing Information for complete prescribing details.
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