Indications for PRIVIGEN:
As replacement therapy for primary humoral immunodeficiency (eg, congenital agammaglobulinemia, X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).
Adults and Children:
<3yrs: not established. ≥3yrs: Give by IV infusion at an initial rate of 0.5mg/kg/min, if tolerated may increase to 8mg/kg/min. Renal dysfunction, thrombosis risk: give at the minimum infusion rate practicable. Usual dose: 200–800mg/kg every 3–4 weeks. Adjust subsequent dose based on serum IgG trough levels and clinical response.
IgA-deficiency with antibodies against IgA and history of hypersensitivity. Hyperprolinemia. Previous severe reaction to human immune globulin.
Thrombosis. Renal dysfunction and acute renal failure.
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, obese, hypovolemia: increased risk of renal dysfunction and 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, delayed hemolytic anemia, transfusion-related acute lung injury (eg, respiratory distress, pulmonary edema, hypoxemia). History of hypertension. Monitor BP before, during and after infusions. Antibody formation. Risk of transmission of viral diseases. Have epinephrine inj available. Elderly. Pregnancy. Nursing mothers.
Concomitant nephrotoxic drugs: increased risk of renal toxicity. May affect response to live virus vaccines. May interfere with serological test interpretation.
Headache, fatigue, nausea, chills, vomiting, pain (back, pharyngolaryngeal, extremity), elevated body temperature, abdominal pain, diarrhea, cough, stomach discomfort, chest pain, joint swelling/effusion, influenza-like illness, urticaria, dizziness, hemolysis, anemia, asthenia, hypertension, leukopenia, rash; hypersensitivity, hyperproteinemia, increased serum viscosity, hyponatremia; rare: aseptic meningitis syndrome (esp. high dose of 2g/kg), TRALI, thrombosis.
Single-use vial (50mL, 100mL, 200mL, 400mL)—1