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FLEBOGAMMA 10% DIF
Primary immune deficiency
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Drug Name:

FLEBOGAMMA 10% DIF Rx

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

Company:
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).

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.

Contraindications:

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

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.

Interactions:

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

See Also:

FLEBOGAMMA 5% DIF

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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