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Primary immune deficiency
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Drug Name:


Generic Name and Formulations:
Immune globulin (human) 5g/50mL, 10g/100mL, 20g/200mL; liq for IV infusion; preservative- and sucrose-free.

Grifols Biologicals, Inc.

Therapeutic Use:

Indications for FLEBOGAMMA 10% DIF:

Primary immune deficiency (eg, common variable immunodeficiency, X-linked agammaglobulinemia, severe combined immunodeficiency, Wiskott-Aldrich syndrome).


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.


Not established.


IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.


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.


Avoid live vaccines. Concomitant nephrotoxic drugs: increased risk of acute renal failure. May cause positive direct or indirect antiglobulin (Coombs') test.

See Also:


Pharmacological Class:

Immune globulin.

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.

How Supplied:

Single-use vial—1

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