Cytomegalovirus immune globulin Side Effects

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.

For the Consumer

Applies to cytomegalovirus immune globulin: intravenous solution

CMV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although CMV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using CMV IG.

Treatment with immune globulin products such as CMV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify your doctor immediately if you develop decreased urination, sudden weight gain, fluid retention or swelling, or shortness of breath. These may be signs of kidney problems.

Rare cases of aseptic meningitis syndrome (AMS) have been associated with the use of immune globulin products such as CMV IG. Notify your doctor immediately if you experience severe headache, neck stiffness, drowsiness, fever, eye sensitivity to light, painful eye movements, and nausea or vomiting. These may be signs of AMS. Stopping treatment with the immune globulin has resulted in resolution of AMS without any lasting problems.

Notify your doctor immediately if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to CMV IG.

Other less serious side effects may also occur. Upon injection of the medication, some patients experience the following side effects:

• flushing or sweating;

• wheezing;

• muscle cramps;

• joint pain;

• nausea or vomiting; or

• fever or chills.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

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.

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.

Cardiovascular

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

Dermatologic

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

Gastrointestinal

Gastrointestinal side effects have included abdominal pain.

Hematologic

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

Hepatic

Hepatic side effects have included hepatic dysfunction.

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.

Musculoskeletal

Musculoskeletal side effects have included back pain.

Nervous system

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

Respiratory

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

Other

Other side effects have included pyrexia and rigors.

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