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Minor reactions such as flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, and wheezing were the most frequent adverse reactions observed during the clinical trials of Cytogam® (cytomegalovirus immune globulin intravenous human) , Cytomegalovirus Immune Globulin Intravenous (Human). The incidence of these reactions during the clinical trials was less than 6.0% of all infusions and such reactions were most often related to infusion rates. A decrease in blood pressure was observed in 1 of 1039 infusions in clinical trials of Cytogam® (cytomegalovirus immune globulin intravenous human) . If a patient develops a minor side effect, slow the rate immediately or temporarily interrupt the infusion.

Increases in serum creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following IGIV infusion. Progression to oliguria or anuria requiring dialysis has been observed. Types of severe renal adverse events that have been seen following IGIV therapy include acute renal failure, acute tubular necrosis, proximal tubular nephropathy and osmotic nephrosis (18-25).

Severe reactions such as angioneurotic edema and anaphylactic shock, although not observed during clinical trials, are a possibility. 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; therefore, carefully adhere to the infusion rates as outlined under "DOSAGE AND ADMINISTRATION." If anaphylaxis or drop in blood pressure occurs, discontinue infusion and use antidote such as diphenhydramine and adrenalin.

Postmarketing:

The following adverse reactions have been identified and reported during the post-approval use of IGIV products (38):

Respiratory. Apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion Associated Lung Injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm

Cardiovascular: Cardiac arrest, thromboembolism, vascular collapse, hypotension

Neurological: Coma, loss of consciousness, seizures, tremor

Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis

Hematologic: Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs) test

General/Body as a Whole: Pyrexia, Rigors

Musculoskeletal: Back pain

Gastrointestinal:Hepatic dysfunction, abdominal pain

Because postmarketing reporting of these reactions is voluntary and the at-risk populations are of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to exposure to the product. Such is also the case with literature reports authored independently.

Antibodies present in immune globulin preparations may interfere with the immune response to live virus vaccines such as measles, mumps, and rubella; therefore, vaccination with live virus vaccines should be deferred until approximately three months after administration of Cytogam® (cytomegalovirus immune globulin intravenous human) . If such vaccinations were given shortly after Cytogam® (cytomegalovirus immune globulin intravenous human) , a revaccination may be necessary. Admixtures of Cytogam® (cytomegalovirus immune globulin intravenous human) with other drugs have not been evaluated. It is recommended that Cytogam® (cytomegalovirus immune globulin intravenous human) be administered separately from other drugs or medications which the patient may be receiving (see DOSAGE AND ADMINISTRATION section).

REFERENCES

18. 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;8:1788-1794.

19. Cantu TG, Hoehn-Saric EW, Burgess KM, Racusen L, Scheel PJ. Acute renal failure associated with immunoglobulin therapy. Am J Kidney Dis 1995;25:228-234.

20. Hansen-Schmidt S, Silomon J, Keller F. Osmotic nephrosis due to high-dose intravenous immunoglobulin therapy containing sucrose (but not with glycine) in a patient with immunoglobulin A nephritis. Am J Kidney Dis 1996;28: 451-453.

21. Tan E, Hajinazarian M, Bay W, Neff J, Mendell JR. Acute renal failure resulting from intravenous immunoglobulin therapy. Arch Neurol 1993;50:137-139.

22. Winward D, Brophy MT. Acute renal failure after administration of intravenous immunoglobulin: Review of the literature and case report. Pharmacotherapy 1995;15:765-772.

23 Phillips AO. Renal failure and intravenous immunoglobulin [letter; comment]. Clin Nephrol 1992;37:217.

24. Lindberg HA, Wald MH, Barker MH. Renal changes following administration of hypertonic solutions. Arch Intern Med 1939;63:907-918.

25. Rigdon RH, Cardwell ES. Renal lesions following the intravenous injection of a hypertonic solution of sucrose. Arch Intern Med 1942;69:670-690.

38. Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Trans Med Rev 2003;17:241-251.

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.