friends [50:<1% (Limited to important or life-threatening): Abdominal pain, acute intravascular hemolysis, acute renal failure, altered blood pressure, anaphylaxis, apnea, acute respiratory distress, arthralgia, aseptic meningitis, bronchospasm, bullous rash, chills, circulatory shock, coma, cyanosis, diarrhea, dyspnea, epidermolysis, erythema multiforme, flushing, hemolysis, hepatic insufficiency, hypersensitivity reaction, hypoxemia, hypotension, leukopenia, loss of consciousness, malaise, myalgia, pancytopenia, positive direct Coombs test, proximal tubular nephropathy, pulmonary edema, renal disease (osmotic nephropathy), renal insufficiency, seizure, Stevens-Johnson syndrome, syncope, tachycardia, thrombocytopenia, thromboembolism, transfusion-related acute lung injury (TRALI), urticaria, wheezing ALERT: U.S. Boxed Warning Interactions with glucose monitoring systems: Blood glucose measurement in patients receiving Vaccinia Immune Globulin Intravenous (Human) (VIGIV) must be done with a glucose-specific method (monitor and test strips) to avoid interference by maltose contained in VIGIV. Glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase method (monitor and test strips) must not be used for blood glucose testing in patients receiving VIGIV, since maltose in IGIV products has been shown to give falsely high blood glucose levels in these testing systems. This could result in the inappropriate administration of insulin, resulting in life-threatening hypoglycemia. Cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings. Carefully review the product information of the blood glucose testing system, including that of the test strips, to determine if the system is appropriate for use with maltose-containing parenteral products. Warnings/Precautions Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions can occur; discontinue therapy and institute immediate treatment (including epinephrine 1 mg/mL). Contains trace amounts of IgA; use caution in IgA-deficient patients; contraindicated in IgA-deficient patients with antibodies against IgA and a history of IgA hypersensitivity. Aseptic meningitis: Aseptic meningitis syndrome (AMS) has been reported with intravenous immune globulin administration and usually begins within several hours to 2 days following treatment; may occur more frequently with high total doses (2 g/kg). Discontinuation of treatment has resulted in remission of AMS within several days without sequelae. Hemolysis: Intravenous immune globulin has been associated with antiglobulin hemolysis; monitor for signs of hemolytic anemia. Risk factors for hemolysis include high doses given either as a single administration or divided over several days, underlying associated inflammatory conditions (eg, elevated C-reactive protein or erythrocyte sedimentation rate), and non-O blood group. If signs/symptoms of hemolysis are present, perform appropriate laboratory testing for confirmation. Infusion reactions: Adverse reactions may be related to rate of infusion; closely monitor patient during and immediately following infusion. Closely follow the recommended infusion rates. Pulmonary edema: Monitor for transfusion-related acute lung injury (TRALI); noncardiogenic pulmonary edema has been reported with intravenous immune globulin use. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, and fever in the presence of normal left ventricular function. Usually occurs within 1 to 6 hours after infusion. If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies in both the product and patient s serum. Renal effects: Renal dysfunction, acute renal failure, osmotic nephropathy, proximal tubular nephropathy, and fatalities may occur; usually occurs in patients receiving total doses containing 400 mg/kg of sucrose (VIGIV does not contain sucrose). Thrombotic events: Thrombotic events have been reported with administration of intravenous immune globulin; use with caution in patients with a history of cardiovascular risk factors or arterial or venous thrombosis, advanced age, estrogen use, indwelling central venous catheters, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triglycerides, or monoclonal gammopathies. For patients at risk for of thrombosis, administer at the minimum dose (do not exceed maximum dose), minimum concentration available, and minimum infusion rate practicable, ensure adequate hydration before administration. Disease-related concerns: Hypovolemia: Patients should not be volume depleted prior to therapy. Postvaccinial encephalitis: Not effective for use in postvaccinial encephalitis. Renal impairment: Use with caution in patients with preexisting renal insufficiency and in patients at risk of developing renal insufficiency (eg, diabetes mellitus, patients> 65 years, volume depletion, paraproteinemia, sepsis, patients receiving known nephrotoxic drugs); administer at the minimum rate of infusion (do not exceed the recommended infusion rate). Ensure patients are not volume depleted prior to VIGIV infusion. Monitor renal function and urine output closely. If renal function deteriorates, consider discontinuing therapy. Vaccinia keratitis: Exercise caution when using VIGIV in the treatment of patients with complications due to vaccinia vaccination that include concomitant vaccinia keratitis, because a single study in rabbits demonstrated increased corneal scarring upon intramuscular vaccinia immune globulin administration in vaccinia keratitis. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations: Elderly: Use with caution in the elderly; may be at increased risk for renal dysfunction/failure and thromboembolic events. Dosage form specific issues: Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer. Maltose: Product may contain maltose. [US Boxed Warning]: Maltose in IGIV products may give falsely high blood glucose levels in certain types of glucose tests systems. Falsely-elevated blood glucose readings may result in unnecessary insulin use and life-threatening hypoglycemia; cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings. Glucose specific monitoring systems and test strips are recommended. Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer s labeling. Other warnings/precautions: Appropriate use: Vaccinia immune globulin is currently not recommended for use in persons with contraindications to smallpox vaccine; inadvertent exposure to smallpox vaccine in high-risk populations should be reported to the CDC so that standardized treatment may be provided. VIGIV is not considered to be effective in the treatment of postvaccinial encephalitis. Monitoring Parameters Renal function (including BUN, serum creatinine) and urine output (before initial infusion and at clinically appropriate intervals). Baseline assessment of blood viscosity in patients at risk for hyperviscosity. During infusion, monitor patient for signs of infusion-related reactions, including (but not limited to) flushing, fever, chills, respiratory distress, blood pressure or heart rate changes; transfusion-related lung injury (typically 1 to 6 hours after infusion) and signs/symptoms of hemolysis (prior to infusion and ~36 to 96 hours postinfusion). Pregnancy Risk Factor C Pregnancy Considerations Animal reproduction studies have not been conducted. Immune globulins cross the placenta in increased amounts after 30 weeks gestation. There are no adequate and well-controlled studies in pregnant women. Vaccinia immune globulin is currently not recommended for use in persons with contraindications to smallpox vaccine; inadvertent exposure to smallpox vaccine in high risk populations (eg pregnant women) should be reported to the CDC so that standardized treatment may be provided. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience sensation of cold or warmth, headache, vomiting, lack of appetite, muscle spasm, back pain, tremors, sweating a lot, or nausea. Have patient report immediately to prescriber signs of kidney problems (urinary retention, blood in urine, change in amount of urine passed, or weight gain), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), angina, coughing up blood, shortness of breath, tachycardia, loss of strength and energy, dark urine, jaundice, severe dizziness, passing out, injection site pain, chills, joint pain, burning or numbness feeling, pale skin, or signs of aseptic meningitis (headache, fever, chills, severe nausea or vomiting, stiff neck, rash, bright lights that bother eyes, fatigue, or illogical thinking) (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients. Next Interactions Print this page Add to My Med List More about vaccinia immune globulin Side Effects During Pregnancy Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: immune globulins Consumer resources Vaccinia Vaccinia immune globulin, human Intravenous (Advanced Reading) Professional resources Other brands: CNJ-016 Injection Related treatment guides Smallpox Vaccine Reaction ]} Drug Status Availability Discontinued C Pregnancy Category Risk cannot be ruled out Vaccinia immune globulin Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Immune globulins Related Drugs immune globulins Gammagard , RhoGAM , Hizentra , Synagis , Gamunex , Privigen Smallpox Vaccine Reaction cidofovir , vaccinia immune globulin , More...} } is certain
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