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VIGIV

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VIGIV

Warnings
Precautions

WARNINGS

Vaccinia Immune Globulin Intravenous (Human) (VIGIV) is prepared from human plasma and, like other plasma products, carries the possibility for transmission of blood-borne viral agents and, theoretically, the Creutzfeld Jakob disease agent. The risk of transmission of recognized blood-borne viruses has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current viral infections, and by implementing process steps for the inactivation and/or removal of certain potential viruses during manufacturing. Despite these measures, some as yet unrecognized blood-borne viruses may not be removed by the manufacturing process; therefore VIGIV (vaccinia immune globulin intravenous) , like any other blood product, should be given only if a benefit is expected (see PRECAUTIONS – General).

Severe immediate hypersensitivity reactions to plasma-derived products are generally rare. These reactions can occur in very rare cases of IgA deficiency or hypersensitivity to human globulin. In case of allergic or anaphylactic reaction, the infusion should be stopped immediately. The product should be administered only in a setting where appropriate equipment and personnel trained in the management of acute anaphylaxis are available (see PRECAUTIONS section). In case of shock, the current medical standards for treatment of shock should be observed.

Immune globulin intravenous (Human) (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, proximal tubular nephropathy, and death.10, 11 Although these reports of renal dysfunction and acute renal failure have been associated with the use of many licensed IGIV products, those that contained sucrose as a stabilizer and were administered at daily doses of 400 mg Ig/kg or greater have accounted for a disproportionate share of the total number.12 CNJ-016™ does not contain sucrose (5%) as a stabilizer, and the recommended dose is less than 400mg Ig/kg. Patients predisposed to acute renal failure include the following: patients with any degree of pre-existing renal insufficiency, diabetes mellitus, volume depletion, sepsis, or paraproteinemia, patients who are at least 65 years of age, or patients who are receiving known nephrotoxic drugs. Especially in such patients, as well as in patients judged to be at risk of thrombotic and thromboembolic events, CNJ-016™ should be administered at the minimum concentration available and at the minimum rate of infusion practicable.9

The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it (see PRECAUTIONS – General).

PRECAUTIONS

General

VIGIV (vaccinia immune globulin intravenous) should only be administered intravenously. VIGIV (vaccinia immune globulin intravenous) should not be used if the solution is turbid.

Certain adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under DOSAGE AND ADMINISTRATION must be closely followed. Patients and their vital signs must be closely monitored and carefully observed for any symptoms throughout the infusion period and immediately following an infusion.

Although acute systemic allergic reactions were not seen in clinical trials with VIGIV (see ADVERSE REACTIONS), the product should be administered only in a setting where appropriate equipment and personnel trained in the management of acute anaphylaxis are available. If hypotension or anaphylaxis occurs, the administration of VIGIV (vaccinia immune globulin intravenous) should be discontinued immediately and supportive care given as needed.

VIGIV (vaccinia immune globulin intravenous) should be used with caution in patients with pre-existing renal insufficiency and in patients judged to be at increased risk of developing renal insufficiency (including, but not limited to those with diabetes mellitus, age greater than 65 years, volume depletion, paraproteinemia, sepsis, and patients receiving known nephrotoxic drugs). In these cases, it is important to ensure that patients are not volume depleted before VIGIV (vaccinia immune globulin intravenous) infusion. Do not exceed the recommended infusion rate, and follow the infusion schedule closely (see DOSAGE AND ADMINISTRATION section). Most cases of renal insufficiency following administration of IGIV have occurred in patients receiving total doses containing 400 mg/kg of sucrose or greater. CNJ-016™ does not contain sucrose. No prospective data are currently available in patients with risk factors for renal insufficiency and/or thrombois/thromboembolism to identify a maximum safe dose, concentration, and/or rate of infusion for CNJ-016™.

Vaccinia Immune Globulin Intravenous (Human) (VIGIV), like other products made from human plasma, may contain infectious agents, such as viruses, that can cause disease. The risk that VIGIV (vaccinia immune globulin intravenous) will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses (see DESCRIPTION section). However, despite these measures, VIGIV (vaccinia immune globulin intravenous) can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present. All infections thought to have been possibly transmitted by this product should be reported by the physician or other health care provider to Cangene Corporation at 1-877-CANGENE (226-4363).

An aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV administration.13, 14, 15, 16 The syndrome usually begins within several hours to two days following IGIV treatment. It is characterized by symptoms and signs including the following: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, and nausea and vomiting. Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per cubic millimeter, predominately from the granulocytic series, and with elevated protein levels up to several hundred mg/dL. Patients exhibiting such symptoms and signs should receive a thorough neurological examination to rule out other causes of meningitis.13, 14, 15, 16 AMS may occur more frequently in association with high total doses (2 g/kg) of IGIV treatment (in comparison, at the recommended dosage of 6000 U/kg, a patient may be exposed to up to 0.12 g/kg protein after VIGIV (vaccinia immune globulin intravenous) administration). Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.9

Hemolysis

IGIV 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. 17, 18, 19Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced red blood cell sequestration. 20 VIGIV (vaccinia immune globulin intravenous) recipients should be monitored for clinical signs and symptoms of hemolysis (see PRECAUTIONS - Laboratory Tests).

Transfusion-Related Acute Lung Injury (TRALI)

There have been reports of noncardiogenic pulmonary edema [Transfusion-Related Acute Lung Injury (TRALI)] in patients administered IGIV.21 TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever and typically occurs within 1 to 6 hours after transfusion. Patients with TRALI may be managed using oxygen therapy with adequate ventilatory support.

VIGIV (vaccinia immune globulin intravenous) recipients should be monitored for pulmonary adverse reactions. If TRALI is suspected, appropriate tests should be performed for the presence of anti-neutrophil antibodies in both the product and patient serum (see PRECAUTIONS - Laboratory Tests).

Thrombotic Events

Thrombotic events have been reported in association with IGIV.22, 23, 24 Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity. The potential risks and benefits of VIGIV (vaccinia immune globulin intravenous) should be weighed against those of alternative therapies for all patients for whom VIGIV (vaccinia immune globulin intravenous) administration is being considered. 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 (see PRECAUTIONS - Laboratory Tests).

Laboratory Tests

If signs and/or symptoms of hemolysis are present after VIGIV (vaccinia immune globulin intravenous) infusion, appropriate confirmatory laboratory testing should be done. If TRALI is suspected, appropriate tests should be performed for the presence of anti-neutrophil antibodies in both the product and patient serum.

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.

Pregnancy Category C

Animal reproduction studies have not been conducted with VIGIV (vaccinia immune globulin intravenous) ; therefore it is not known whether VIGIV (vaccinia immune globulin intravenous) can cause fetal harm when administered to a pregnant woman or whether it can affect reproduction capacity. However, immune globulins have been widely used during pregnancy for many years without any apparent negative reproductive effects. 27 The risk/benefit of VIGIV (vaccinia immune globulin intravenous) administration should be assessed for each individual case.

Nursing Mothers

It is not known whether VIGIV is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VIGIV (vaccinia immune globulin intravenous) is administered to a nursing mother.

Pediatric and Geriatric Use

Safety and effectiveness in the pediatric or geriatric populations have not been established for VIGIV (vaccinia immune globulin intravenous) .

REFERENCES

9. Cytogam®, cytomegalovirus immune globulin intravenous (human) (CMV-IGIV). In: Physician's Desk Reference. 58th ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2004:1907-1909.

10. Perazella MA, Cayco AV. Acute renal failure and intravenous immune globulin: sucrose nephropathy in disguise? Am J Ther 1998; 5:399-403.

11. Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after intravenous immune globulin therapy: a report of two cases and an analysis of the literature. J Am Soc Nephrol 1997; 8:1788-1793.

12. Important Drug Warning ("Dear Doctor") letter. Center for Biologics Evaluation and Research, Food and Drug Administration; 1998.

13. Sekul EA, Cupler EJ, Dalakas MC. Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: frequency and risk factors. Ann Intern Med 1994; 121:259-262.

14. Kato E, Shindo S, Eto Y, et al. Administration of immune globulin associated with aseptic meningitis. JAMA 1988; 259:3269-3270.

15. Casteels-Van Daele M, Wijndaele L, Hunninck K. Intravenous immunoglobulin and acute aseptic meningitis. N Engl J Med 1990; 323:614-615.

16. Scribner C, Kapit R, Philips E, Rickels N. Aseptic meningitis and intravenous immunoglobulin therapy. Ann Intern Med 1994; 121:305-306.

17. Copelan EA, Strohm PL, Kennedy MS, Tutschka PJ. Hemolysis following intravenous immune globulin therapy. Transfusion 1986; 26:410-412.

18. Thomas MJ, Misbah SA, Chapel HM, Jones M, Elrington G, Newsom-Davis J Hemolysis after high-dose intravenous Ig. Blood 1993; 82:3789.

19. Reinhart WH, Berchtold PE. Effect of high-dose intravenous immunoglobulin therapy on blood rheology. Lancet 1992; 339:662-664.

20. Kessary-Shoham H, Levy Y, Shoenfeld Y, Lorber M, Gershon H. In vivo administration of intravenous immunoglobulin (IVIg) can lead to enhanced erythrocyte sequestration. J Autoimmunity 1999; 13:129-135.

21. Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001; 4:264-268.

22. Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology 1994; 44:223-226.

23. Woodruff RK, Grigg AP, Firkin FC, Smith IL. Fatal thrombotic events during treatment of autoimmune thrombocytopenia with intravenous immunoglobulin in elderly patients. Lancet 1986; 2:217-218.

24. Wolberg AS, Kon RH, Monroe DM, Hoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000; 65:30-34.

27. Bowman, JM. Antenatal suppression of Rh alloimmunization. Clin Obst & Gynec 1991; 34:296-303.

Last reviewed on RxList: 3/5/2009
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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