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Flebogamma 10% Dif Generic Name & Formulations
Legal Class
Rx
General Description
Immune globulin (human) 5g/50mL, 10g/100mL, 20g/200mL; liq for IV infusion; preservative- and sucrose-free.
Pharmacological Class
Immune globulin.
See Also
How Supplied
Single-use vial—1
Manufacturer
Flebogamma 10% Dif Indications
Indications
Primary immune deficiency (eg, common variable immunodeficiency, X-linked agammaglobulinemia, severe combined immunodeficiency, Wiskott-Aldrich syndrome).
Flebogamma 10% Dif Dosage and Administration
Adult
Individualize. Give by IV infusion. 300‒600mg/kg every 3‒4 weeks. Initial infusion rate: 0.01mL/kg/min (1mg/kg/min) for first 30mins. Maintenance dose rate: may gradually increase to 0.08mL/kg/min (8mg/kg/min) if tolerated. Risk of renal dysfunction/failure or thrombosis: give at minimum practicable infusion rate.
Children
Not established.
Flebogamma 10% Dif Contraindications
Contraindications
IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Flebogamma 10% Dif Boxed Warnings
Not Applicable
Flebogamma 10% 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 10% Dif Pharmacokinetics
See Literature
Flebogamma 10% 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 10% 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 10% Dif Clinical Trials
See Literature
Flebogamma 10% Dif Note
Not Applicable
Flebogamma 10% Dif Patient Counseling
See Literature
