Cytomegalovirus immunoglobulin human 5,000units/50ml solution for infusion vials

CMV-IGIV is made from human plasma and, like other plasma products, carries the possibility for transmission of blood-borne viral agents and possibly, the Creutzfeldt-Jakob disease (CJD) prion. The risk of transmission of recognized blood-borne viruses is considered low due to the viral inactivation and removal properties in the Cohn-Oncley cold ethanol .
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Renal Failure

Renal dysfunction, acute renal failure (ARF), acute tubular necrosis (ATN), proximal tubular nephropathy, osmotic nephrosis, and death reported in patients receiving IGIV. Increases in blood urea nitrogen (BUN) and serum creatinine have occurred as soon as 1–2 days following IGIV treatment and this has progressed to oliguria or anuria .
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TRALI (transfusion-associated lung injury)

TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever.

It typically occurs within 1-6 hours after transfusion of the immunoglobulin. Patients with TRALI should be managed using oxygen therapy combined with ventilatory support [FDA label].

Hemolysis

Immune Globulin Intravenous (Human) (IGIV) products may 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, sometimes, hemolysis. Hemolytic anemia may develop after IGIV therapy due to enhanced red blood cell sequestration [FDA label].

**Thrombotic events

Patients at risk include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity.

The possible risks and benefits of IGIV should be weighed against those of alternative therapies for all patients for whom IGIV administration is being considered. Baseline assessment of blood viscosity are an important consideration for patients at risk for blood hyperviscosity [FDA label].

Aseptic meningitis syndrome**

An aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with Immune Globulin Intravenous (Human) (IGIV) treatment. The syndrome normally begins within several hours to 2 days after treatment.

This syndrome is characterized by symptoms and signs including severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, and nausea and vomiting [FDA label].

Cerebrospinal fluid (CSF) studies are frequently positive with pleocytosis up to several thousand cells per cu.mm., predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL. Patients experiencing such symptoms and signs must receive a thorough neurological assessment, including CSF studies, to rule out other possible causes of meningitis. This condition may occur more frequently in association with high doses (2 g/kg or greater) of IGIV treatment.

Discontinuation of IGIV treatment has been followed by the remission of aseptic meningitis syndrome within several days without long-term sequelae [FDA label].


Cytomegalovirus immune globulin (CMV-IGIV) is categorized in FDA pregnancy risk category C. No well-controlled studies have been completed in pregnant women and it is unknown whether CMV-IGIV may cause female harm or negatively affect the reproductive system. According to the Advisory Committee on Immunization Practices, administration of immune globulin to pregnant women results in no known risk to the fetus [FDA label].

No data are available from the manufacturer regarding the use of cytomegalovirus immune globulin (CMV-IGIV) while breastfeeding and it is unknown whether CMV-IGIV is excreted in breast milk .
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