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Flebogamma 5% Dif Generic Name & Formulations
Legal Class
Rx
General Description
Immune globulin (human) 0.5g/10mL, 2.5g/50mL, 5g/100mL, 10g/200mL, 20g/400mL; liq for IV infusion; preservative- and sucrose-free.
Pharmacological Class
Immune globulin.
See Also
How Supplied
Single-use vial—1
Manufacturer
Flebogamma 5% Dif Indications
Indications
Primary immune deficiency (eg, common variable immunodeficiency, X-linked agammaglobulinemia, severe combined immunodeficiency, Wiskott-Aldrich syndrome).
Flebogamma 5% Dif Dosage and Administration
Adult
Individualize. Give by IV infusion. 300‒600mg/kg every 3‒4 weeks. Initial infusion rate: 0.01mL/kg/min (0.5mg/kg/min) for first 30mins. Maintenance dose rate: may gradually increase to max 0.10mL/kg/min (5mg/kg/min) if tolerated. Risk of renal dysfunction/failure or thrombosis: give at minimum practicable infusion rate.
Children
Not established.
Flebogamma 5% Dif Contraindications
Contraindications
IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Flebogamma 5% Dif Boxed Warnings
Not Applicable
Flebogamma 5% Dif Warnings/Precautions
Warnings/Precautions
Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular risk factors: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Pre-existing renal insufficiency, diabetes, >65yrs, hypovolemia, sepsis, paraproteinemia: increased risk of renal dysfunction or acute renal failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Monitor for aseptic meningitis, hemolysis, and hemolytic anemia. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Contains human plasma; monitor for possible infection transmission. Have epinephrine inj available. Elderly. Pregnancy (Cat.C). Nursing mothers.
Flebogamma 5% Dif Pharmacokinetics
See Literature
Flebogamma 5% Dif Interactions
Interactions
Avoid live vaccines. Concomitant nephrotoxic drugs: increased risk of acute renal failure. May cause positive direct or indirect antiglobulin (Coombs') test.
Flebogamma 5% Dif Adverse Reactions
Adverse Reactions
Headache, pyrexia, pain, injection site reactions (eg, edema, swelling, inflammation), diarrhea, nausea, vomiting, chills, urticaria, shaking, tachycardia, hypertension, chest pain, pain in extremities, arthralgia, myalgia, sinusitis, dizziness, bronchitis, hypotension; hyperproteinemia, increased serum viscosity, hyponatremia, renal dysfunction (may be fatal); rare: hemolytic anemia, aseptic meningitis syndrome (esp. with high doses or rapid infusion), TRALI, thrombosis.
Flebogamma 5% Dif Clinical Trials
See Literature
Flebogamma 5% Dif Note
Not Applicable
Flebogamma 5% Dif Patient Counseling
See Literature
