Cytomegalovirus immune globulin (CMV IG) injection

You should not use this medicine if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Applies to cytomegalovirus immune globulin: intravenous solution

General

The most frequent side effects have included minor reactions such as flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, and wheezing in < 6.0% of all infusions. These reactions were most often related to the infusion rate. A decrease in blood pressure was observed in 1 of 1039 infusions in clinical trials. If a minor reaction occurs, the infusion should be slowed or temporarily interrupted.[Ref]

Renal

Renal side effects have included increases in serum creatinine and blood urea nitrogen (BUN) within 1 to 2 days after IGIV infusion, oliguria or anuria requiring dialysis, acute renal failure, acute tubular necrosis, proximal tubular nephropathy, and osmotic nephrosis.[Ref]

Cardiovascular

Cardiovascular side effects have included cardiac arrest, thromboembolism, vascular collapse, and hypotension.[Ref]

Dermatologic

Dermatologic side effects have included Stevens-Johnson syndrome, epidermolysis, erythema multiforme, and bullous dermatitis.[Ref]

Gastrointestinal

Gastrointestinal side effects have included abdominal pain.[Ref]

Hematologic

Hematologic side effects have included pancytopenia, leukopenia, hemolysis, and positive direct antiglobulin (Coombs) test.[Ref]

Hepatic

Hepatic side effects have included hepatic dysfunction.[Ref]

Hypersensitivity

Hypersensitivity reactions including angioneurotic edema and anaphylactic shock may occur. Clinical anaphylaxis may occur even when the patient is not known to be sensitized to immune globulin products. A reaction may be related to the rate of infusion.[Ref]

Musculoskeletal

Musculoskeletal side effects have included back pain.[Ref]

Nervous system

Nervous system side effects have included coma, loss of consciousness, seizures, and tremor.[Ref]

Respiratory

Respiratory side effects have included apnea, acute respiratory distress syndrome (ARDS), transfusion associated lung injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, and bronchospasm.[Ref]

Other

Other side effects have included pyrexia and rigors.[Ref]

Some side effects of cytomegalovirus immune globulin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Cytomegalovirus immune globulin (CMV-IGIV) should be used with caution in patients with renal impairment or patients at risk for development of renal impairment. Do not exceed an infusion rate of 60 mg/kg/hour (maximum volume 75 mL/hour).

If renal function deteriorates, discontinuation of CMV-IGIV should be considered.

Most cases of renal insufficiency have occurred in patients receiving total doses of 350 mg/kg or greater.

No adjustment recommended.

CMV-IGIV does not contain a preservative. The vial should be entered only once for administration purposes and the infusion should begin within 6 hours.

In organ transplants other than kidney from CMV seropositive donors into seronegative recipients, CMV-IGIV should be considered in combination with ganciclovir.