Trade Names:Vaccinia Immune Globulin Intravenous (Human)- Solution for injection 50 mg/mL (immunoglobulin 2,500 mg/vial)
Vaccinia-specific immunoglobulin G (IgG) that directly neutralizes vaccinia virus.
Serum t ½ is about 22 days.
Treatment and/or modification of aberrant infections induced by vaccinia virus (including accidental implantation in eyes, mouth, or other areas where vaccinia infection would constitute a special hazard), eczema vaccinatum, progressive vaccinia, severe generalized vaccinia, and vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy, or in individuals with eczematous skin lesions. Treat complications that include vaccinia keratitis with caution.
Isolated vaccinia keratitis; prior severe reactions associated with parenteral use of vaccinia immune globulin IV or other human immunoglobulin preparations; people with selective IgA deficiency.
IV 2 mL/kg (100 mg/kg) as IV infusion. Dose may be repeated, depending on severity of symptoms and response to treatment.
Higher doses (200 or 500 mg/kg) may be considered in the event the patient does not respond to the initial 100 mg/kg dose. Do not use doses greater than 400 mg/kg in patients predisposed to renal complications.
Store unopened vials in refrigerator (36° to 46°F).
To avoid interference with immune response to live virus vaccines, defer vaccination with live virus vaccines for about 6 mo after giving vaccinia immune globulin IV.
None well documented.
Dizziness, headache, somnolence (at least 5%).
Contact dermatitis, erythema, flushing, skin lacerations, urticaria (at least 5%).
Nasal congestion, sore throat (at least 5%).
Abdominal pain, nausea, toothache (at least 5%).
Injection site reaction (at least 5%).
Arthralgia, back pain (at least 5%).
Dyspnea, upper respiratory tract infection (at least 5%).
Immune globulin IV (Human) products have been reported to be associated with renal function impairment, acute renal failure, osmotic nephrosis, proximal tubular nephropathy, and death. Although many immune globulin IV products have been associated with renal function impairment and acute renal failure, a disproportionate share of the cases were associated with immune globulin IV products that contained sucrose as a stabilizer and were administered at daily doses of 400 mg/kg or more. Immune globulin IV contains sucrose (5%) as a stabilizer, and the recommended dose is 100 mg/kg. Risk factors that predispose to acute renal failure include: any degree of preexisting renal function impairment, diabetes mellitus, volume depletion, sepsis, paraproteinemia, older than 65 yr of age, and concurrent treatment with nephrotoxic drugs. Immune globulin IV should be administered at the minimum concentration available and at the minimum rate of infusion practical, especially in patients predisposed to renal failure.
Monitor vital signs continuously during administration and observe for any symptoms throughout the infusion.
Category C .
Safety and efficacy not established.
Safety and efficacy not established.
Serious reactions can occur. Have epinephrine and resuscitation equipment readily available. Monitor patient for signs and symptoms of allergic reaction. Discontinue therapy immediately severe or anaphylactic reaction noted.
Use with caution in patients with renal function impairment and patients with increased risk of developing renal function impairment. Ensure that such patients are not volume depleted before infusion. Do not exceed recommended infusion rate.
Occurs infrequently and usually begins several h to 2 days after treatment. Signs and symptoms of aseptic meningitis include severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting.
Immune globulin IV products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Monitor patients for signs and symptoms of hemolysis (unexplained fatigue, jaundice, splenomegaly).
Noncardiogenic pulmonary edema has been reported in patients administered immune globulin IV, usually within 1 to 6 h following infusion. Monitor patients for adverse pulmonary reactions (eg, severe respiratory distress, pulmonary edema, hypoxemia, fever, normal left ventricular function). Be prepared to provide oxygen therapy and ventilatory support. Ensure that tests for antineutrophil antibodies in the immune globulin IV and patient are performed and evaluated.
Thrombotic events have been reported in association with IGIV. Risk factors may include: history of atherosclerosis, multiple CV risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. Ensure that baseline blood viscosity is assessed in patients at risk for hyperviscosity (eg, cryoglobulins, monoclonal gammopathy, fasting chylomicronemia, markedly high triglycerides). Monitor patients for signs and symptoms of thromboembolic events (eg, venous thrombophlebitis, pulmonary embolism, pulmonary infarction, stroke, arterial occlusion).
Manifestations would be related to volume overload.
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