Usual Adult Dose for Smallpox Vaccine Reaction

Initial dose: 100 mg/kg (2 mL/kg) by IV infusion over approximately 70 minutes. May repeat, depending on symptom severity and response.

If no response: 200 mg/kg or 500 mg/kg by IV infusion.

Infusion rate: 1 mL/kg/hour for the first 30 minutes, then 2 mL/kg/hour for 30 minutes, then 3 mL/kg/hour for the remainder of the infusion.

Renal Dose Adjustments

Intravenous immune globulins have been associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. IGIV products containing sucrose as a stabilizer and given at daily doses of 400 mg/kg or greater account for a proportionately greater share of the total number. VIGIV contains 5% sucrose as a stabilizer. Patients with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65 years, volume depletion, sepsis, paraproteinemia, or who are receiving nephrotoxic drugs may be at increased risk. Caution is recommended in patients with preexisting renal insufficiency or who are at risk of developing renal insufficiency. Clinicians should ensure that patients are not volume depleted before starting VIGIV infusion.

Liver Dose Adjustments

Data not available

Dose Adjustments

Minor adverse reaction (e.g., flushing): Slow infusion rate or temporarily interrupt infusion.

Severe adverse reaction (anaphylaxis, hypotension): Discontinue infusion and administer epinephrine with or without diphenhydramine.

Precautions

The use of VIGIV for the treatment of isolated vaccinia keratitis or in patients who have previously had severe reactions to immunoglobulin preparations is contraindicated.

Patients with selective immunoglobulin A deficiency may develop antibodies to immunoglobulin A and could have anaphylactic reactions to subsequent administration of blood products containing immunoglobulin A, including vaccinia immune globulin (VIGIV).

VIGIV is made from human plasma and carries the possibility for transmission of blood-borne viral agents and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent. The risk of transmission of known blood-borne viruses is considered to be low because of the purification procedure used for immune globulin products; however, no method has been totally effective in removing all risk and the potential exists for the presence of unknown infectious agents.

IGIV has infrequently been associated with an aseptic meningitis syndrome (AMS). The syndrome usually begins within several hours to two days following IGIV treatment and is characterized by severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, and nausea and vomiting. Cerebrospinal fluid (CSF) studies are often positive with pleocytosis up to several thousand cells per mm3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL. If such symptoms occur, a thorough neurological examination, including CSF studies, is recommended to rule out other causes of meningitis. AMS may occur more frequently in association with high dose (2 g/kg) IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

Patients should be monitored for signs and symptoms of hemolysis. IGIV products can contain blood group antibodies which may cause a positive direct antiglobulin reaction (Coombs test) and, rarely, hemolysis. Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration. If signs of hemolysis occur after IGIV infusion, appropriate confirmatory laboratory testing should be done.

IGIV recipients should be monitored for pulmonary adverse reactions. IGIV has been associated with noncardiogenic pulmonary edema (transfusion-related acute lung injury (TRALI)), which is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. It typically occurs within 1 to 6 hours after transfusion. If TRALI is suspected, appropriate tests should be performed for the presence of anti-neutrophil antibodies in both the IGIV and patient serum.

Thrombotic events have been reported with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. The potential risks and benefits of IGIV should be weighed against those of alternative therapies for all patients for whom IGIV administration is being considered. Because of the potentially increased risk of thrombosis, baseline assessment of blood viscosity should be considered in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies.

Antibodies present in immune globulin preparations may interfere with the immune response to live virus vaccines; therefore, live virus vaccination should be deferred until approximately 6 months after administration of VIGIV. Revaccination may be necessary if such vaccinations were given shortly before or after VIGIV.

Dialysis

Data not available

Other Comments

VIGIV should be refrigerated. Shaking and foaming should be avoided. The infusion should be started within 6 hours after entering the vial and completed within 12 hours.

VIGIV should be infused with a constant infusion pump through a 0.22 micron filter. The recommended infusion rate should not be exceeded. The patient's vital signs should be monitored continuously and careful observation made for any symptoms throughout the infusion.

A loop diuretic may be necessary for managing fluid overload during infusion.