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Products made from human blood may contain infectious agents, such as viruses, that can cause disease. Vaccinia immune globulin intravenous (VIGIV) is a derivative of human plasma. As with other products derived from or purified with human blood components, the remote possibility of contamination or infection with bacteria or viruses exists in patients receiving VIGIV. Screening plasma donors for prior exposure to certain viruses, testing for the presence of viruses, and inactivating and/or reducing viruses has reduced the risk of infectious agent transmission. Transmissibility of the Creutzfeldt-Jakob disease (CJD) virus by plasma-derived products is unknown. The manufacturing processes are designed to reduce the risk of transmitting viral infection; however, none of the processes are completely effective. There is also the possibility that unknown infectious agents may be present in this product. VIGIV should be given only if a benefit is expected. All infections thought by a physician to have been possibly transmitted by VIGIV should be reported to the manufacturer. The health care provider should discuss the risks and benefits of this product with the patient or legal guardian of the patient.[48345]

During clinical trials, the safety of vaccinia immune globulin intravenous (VIGIV) was evaluated in 110 patients who received doses of either 6,000 Units per kg, 9,000 Units per kg, or 24,000 Units per kg. Most adverse reactions were mild in intensity, with no serious adverse reactions reported and no instances of treatment discontinuation due to an adverse reaction. The most commonly reported adverse reactions were headache (5% to 59%), nausea (up to 28.2%), rigors (up to 22.6%), dizziness (up to 17.9%), feeling cold (up to 15.4%), and pain (up to 12.8%). Other adverse reactions reported in at least 5% of drug recipients included feeling hot (up to 9.7%), increased sweating or hyperhidrosis (up to 9.7%), pallor (up to 7.7%), vomiting (up to 7.7%), fever (up to 6.5%), asthenia (up to 6.5%), decreased appetite or anorexia (up to 6.5%), muscle spasms and back pain (up to 6.5%), paresthesias (up to 6.5%), fatigue (up to 5.1%), tremor (up to 5.1%), and peripheral edema (up to 5%).[48345]

Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) product. Acute renal failure, renal dysfunction, osmotic nephrosis, proximal tubular nephropathy, and death have been reported in patients receiving IGIV. Most cases of renal insufficiency associated with IGIV products have occurred in patients receiving total doses containing at least 400 mg/kg of sucrose; VIGIV does not contain sucrose.[48345]

Vaccinia immune globulin intravenous (VIGIV) may contain blood group antibodies that can behave as hemolysins and induce in vivo coating of red blood cells with immune globulin, resulting in a positive direct antiglobulin reaction and hemolysis. Hemolytic anemia due to enhanced red blood cell sequestering may ensue. Monitored for signs and symptoms of hemolysis in patients receiving VIGIV.[48345]

Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) derived product. Noncardiogenic pulmonary edema [Transfusion-related acute lung injury (TRALI)] has been reported in patients administered IGIV. Characteristics of TRALI include severe respiratory distress, pulmonary edema, hypoxia, normal left ventricular function, and fever and usually occurs within 1 to 6 hours after transfusion. Other respiratory adverse events reported during postapproval use of IGIV products include apnea, acute respiratory distress syndrome (ARDS), cyanosis, dyspnea, bronchospasm, and wheezing. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]

Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) derived product. Treatment with IGIV has been associated with the development of an aseptic meningitis syndrome (AMS). The syndrome usually begins within several hours to 2 days following IGIV treatment. It is characterized by signs and symptoms including severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements (ocular pain), nausea, and vomiting. Cerebrospinal fluid (CSF) studies are frequently positive with pleocytosis up to several thousand cells per mm³ (predominately from granulocytic series) and with elevated protein concentrations up to several hundred mg/dL, but culture results are negative. For drug recipients exhibiting the above symptoms, conduct a thorough neurological examination with CSF studies to rule out other causes of meningitis. Stopping IGIV treatment has resulted in remission within several days without sequelae.[48345]

Mild and transient chest pain (unspecified) has been reported on the same day as treatment with vaccinia immune globulin intravenous (VIGIV). VIGIV is a human immune globulin intravenous (IGIV) product. Cardiovascular adverse events reported during postapproval use of other IGIV products include cardiac arrest and sinus tachycardia. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]

Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) product. Hematologic and lymphatic adverse events reported during postapproval use of other IGIV products include anemia, neutropenia, leukopenia, and lymphadenopathy. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]

Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) product. Dermatologic adverse events reported during postapproval use of other IGIV products include Stevens-Johnson syndrome, epidermolysis, erythema multiforme, dermatitis (e.g., bullous dermatitis), urticaria, and other skin reactions. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]

Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) product. Gastrointestinal adverse events reported during postapproval use of other IGIV products include abdominal pain, diarrhea, and hepatic dysfunction. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]

Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) product. Neurologic adverse events reported during postapproval use of other IGIV products include coma, loss of consciousness, and seizures. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]

Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) product. Musculoskeletal and general adverse events reported during postapproval use of other IGIV products include arthralgia, myalgia, malaise, and chest discomfort. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]

Although not observed during clinical trials, severe hypersensitivity reaction such as hypotension, anaphylactic shock, or anaphylactoid reactions are possible with vaccinia immune globulin intravenous (VIGIV). If anaphylaxis or hypotension occurs, discontinue the infusion and give supportive care as needed.[48345]

Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) derived product. Thrombotic events (e.g., thrombosis, thromboembolism) have been associated with IGIV treatment. Before administering VIGIV to an individual at risk for a thrombotic event, ensure the patient is adequately hydrated and do not exceed a maximum daily dose of 12,000 Units per kg.[48345]

Aseptic meningitis syndrome is associated with human immune globulin intravenous (IGIV) therapy, and may occur more frequently with high total doses (i.e., 2 gram per kg). For vaccinia immune globulin intravenous (VIGIV), at the recommended dosage of 6,000 Units per kg, a patient may be exposed to 0.18 gram per kg. Aseptic meningitis syndrome usually begins within several hours to 2 days after IGIV treatment and is characterized by severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting. Cerebrospinal fluid (CSF) studies are frequently positive with pleocytosis up to several thousand cells per mm³ (predominately from granulocytic series) and with elevated protein concentrations up to several hundred mg/dL, but culture results are negative. For drug recipients exhibiting the above symptoms, conduct a thorough neurological examination with CSF studies to rule out other causes of meningitis. Stopping IGIV treatment has resulted in remission within several days without sequelae.[48345]

As with other products derived from or purified with human blood components, the possibility of transmission of viral or bacterial infections exists in patients receiving vaccinia immune globulin intravenous (VIGIV). Screening plasma donors for prior exposure to certain viruses, testing for the presence of viruses, and inactivating or reducing viruses has reduced the risk of transmission of infectious agents. Additionally, the manufacturing processes are designed to reduce the risk of transmitting viral infection; however, none of the processes are completely effective. There is also the possibility that unknown infectious agents may be present in this product.[48345]

Vaccinia immune globulin intravenous (VIGIV) is contraindicated for use in patients with a history of anaphylaxis or severe systemic reaction to VIGIV or another human immune globulin preparation. Anaphylactic reactions to immunoglobulin products, such as VIGIV, are rare. Anaphylactic reactions appear within seconds to several hours after the infusion, and include symptoms such as flushing, facial swelling, dyspnea, cyanosis, anxiety, nausea, vomiting, malaise, hypotension, loss of consciousness, and death.[68110] Use of VIGIV is also contraindicated in IgA-deficient patients with antibodies against IgA and a history of IgA hypersensitivity. IgA deficiency patients with antibodies to IgA could have a severe hypersensitivity reaction to subsequent administration of blood products that contain IgA; VIGIV contains trace amounts of IgA (up to 40 mcg/mL). Administer VIGIV only in a setting where appropriate equipment and personnel trained in the management of acute anaphylaxis are readily available. In case of hypotension, allergic or anaphylactic reactions, discontinue VIGIV immediately and administer supportive care as needed. In case of shock, observe the current medical standards for shock treatment.[48345]

Vaccinia immune globulin intravenous (VIGIV) may be associated with infusion-related reactions (e.g., back or abdominal pain, nausea, vomiting) that develop within the first 10 minutes of drug administration. Additionally, chills, fever, headache, myalgia, and fatigue may begin at the end of the infusion and continue for several hours.[68110] Ensure that the maximum recommended infusion rate of 2 mL/minute is not exceeded. For patients weighing less than 50 kg, the infusion rate should not exceed 0.04 mL/kg/minute. Slower infusion rates may be needed for patients who develop a minor adverse reaction (e.g., flushing) or who are at risk for blood clots. Patients administered human immune globulin intravenous (IGIV) may also develop noncardiogenic pulmonary edema. Transfusion-related acute lung injury (TRALI) typically occurs within 1 to 6 hours of transfusion and is characterized by severe respiratory distress, pulmonary edema, hypoxia, normal left ventricular function, and fever. Patients with TRALI may be managed using oxygen therapy with adequate ventilatory support. Closely monitor patients vital signs and observe for any symptoms, including pulmonary adverse reactions, throughout the infusion period and immediately after the infusion. If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product and patient serum.[48345]

Vaccinia immune globulin intravenous (VIGIV) is contraindicated for use in isolated vaccinia keratitis. A single study in rabbits showed intramuscular administration of vaccinia immune globulin in vaccinia keratitis increased corneal scarring.[48345] However, patients having other complications due to vaccinia vaccination that include vaccinia keratitis, may still receive treatment with VIGIV in addition to trifluridine and ophthalmologic consultation.[68110]

Renal dysfunction, acute renal failure, osmotic nephropathy, proximal tubular nephropathy, and death may occur with use of immune globulin intravenous (IGIV) products. Vaccinia immune globulin intravenous (VIGIV) should be used cautiously in patients with preexisting renal impairment and those at increased risk for volume overload or acute kidney injury (e.g., renal disease, diabetes, dehydration, volume depletion or hypovolemia, sepsis, paraproteinemia, geriatric patients, or those who are receiving known nephrotoxic drugs). Ensure patients are not volume depleted before initiating the infusion. Administer VIGIV at the minimum infusion rate practicable. Do not exceed the maximum recommended infusion rate and follow the infusion schedule closely. Assess renal function before the initial infusion and at appropriate intervals thereafter. Periodic monitoring of renal function and urine output is especially important in patients determined to be at increased risk of developing acute renal failure. Consider discontinuing VIGIV if renal function deteriorates. Most cases of renal insufficiency associated with IGIV products have occurred in patients receiving total doses containing at least 400 mg/kg of sucrose; VIGIV does not contain sucrose. No prospective data are available in patients with risk factors for renal insufficiency to identify a maximum safe dose, concentration, or rate of infusion for VIGIV.[48345]

No well-controlled studies have been conducted regarding use of vaccinia immune globulin intravenous (VIGIV) during pregnancy, and it is unknown whether the product can cause fetal harm or affect the reproductive capacity. According to the Advisory Committee on Immunization Practices, administration of immune globulin preparations to pregnant women results in no known risk to the fetus. Fetal vaccinia may occur if a pregnant woman receives the smallpox vaccine; the likelihood of fetal vaccinia development is unknown but appears to be rare. No indication exists for the routine prophylactic use of VIGIV to prevent fetal vaccinia. Only use during pregnancy if clearly needed; however, if a pregnant woman develops a condition for which use of VIGIV is required, the product should not be withheld.[31173] [43236] [48345]

Vaccinia immune globulin intravenous (VIGIV) may contain blood group antibodies which act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immune globulin, resulting in a positive antiglobulin reaction and hemolysis. Acute hemolysis, consistent with intravascular hemolysis, has been reported and hemolytic anemia can develop after exposure to human immune globulin intravenous (IGIV) due to enhanced RBC sequestration. Risk factors that may be associated with the development of hemolysis after receipt of IGIV products include high doses given as a single administration or divided over several days and non-O blood group. An underlying inflammatory state (as reflected by elevated C-reactive protein or erythrocyte sedimentation rate) is an individual patient factor hypothesized to increase the risk of hemolysis after administration of IGIV; however, the role is uncertain. Closely monitor VIGIV recipients for clinical signs and symptoms of hemolysis, particularly those with the above listed risk factors. Consider appropriate laboratory testing for higher risk patients, including measuring hemoglobin or hematocrit at baseline and again within approximately 36 to 96 hours post-infusion. If signs or symptoms of hemolysis develop or a significant drop in hemoglobin or hematocrit is observed, perform additional confirmatory laboratory testing. If transfusion is indicated for patients who develop hemolysis with clinically compromising anemia after receiving VIGIV, perform adequate cross-matching to avoid exacerbating ongoing hemolysis.[48345]

Thrombotic events have been associated with human immune globulin intravenous (IGIV) products. Patients at increased risk for thrombotic events include those with a history of arteriosclerosis, multiple cardiovascular risk factors (coronary artery disease), advanced age, impaired cardiac output (heart failure), hypercoagulable disorders, prolonged periods of immobilization, history of arterial or venous thrombosis, estrogen use, indwelling central vascular catheters, and known or suspected hyperviscosity. When considering treatment options, weight the potential risks and benefits of vaccinia immune globulin intravenous (VIGIV) therapy against those of alternative therapies. In patients where the benefits of VIGIV outweigh the potential risk of a thrombotic or thromboembolic event, administer VIGIV at the minimum concentration available and at the minimum infusion rate practicable. Ensure the patient is adequately hydrated before administration and do not exceed a maximum daily dose of 12,000 Units per kg in patients with thrombotic risk factors. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including patients with cryoglobulins, fasting chylomicronemia, hypertriglyceridemia, or monoclonal gammopathies.[48345]

There are no data on the presence of vaccinia immune globulin intravenous (VIGIV) in human milk, the effects on the breast-fed infant, or the effects on milk production. Case reports of 2 nursing mothers receiving intravenous immune globulin therapy suggest transfer of IgG and IgM into the colostrum and breast milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[48345] [48199]

Vaccinia immune globulin intravenous (VIGIV) contains maltose, and use may result in laboratory test interference, specifically falsely elevated glucose readings leading to unrecognized hypoglycemia or inappropriate insulin administration. When administering vaccinia immune globulin to patients with diabetes mellitus, blood glucose should be measured using a glucose-specific method. Do not use blood glucose monitors or strips using glucose dehydrogenase pyrroloquinolinequinone (GDH-PGG) or glucose-dye-oxidoreductase (GDO) because the presence of maltose can interfere with their readings. Carefully review the product information of the blood glucose testing system to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, contact the manufacturer of the system to ensure appropriate use. Additionally, antibodies present in VIGIV may interfere with some serological tests. After administration of immune globulins like VIGIV, a transitory increase of passively transferred antibodies in the patient's blood may result in positive results in serological testing (e.g., Coomb's test).[48345]

Vaccinia immune globulin intravenous (VIGIV) may impair the efficacy of live attenuated virus vaccines. Therefore, vaccinations with live virus vaccines should be delayed until 3 months after VIGIV administration. Persons who received VIGIV shortly after a live virus vaccination should be revaccinated 3 months after administration of the immune globulin.[48345]