Cytogam Side Effects, and Drug Interactions - Cytomegalovirus Immune Globulin Intravenous (Human)

Cytogam Side Effects, and Drug Interactions - Cytomegalovirus Immune Globulin Intravenous (Human)

SIDE EFFECTS

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®. 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®. 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 (18-20).

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.

Drug Interactions:    Antibodies present in immune globulin preparation 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®. If such vaccinations were given shortly after CytoGam®, a revaccination may be necessary. Admixtures of CytoGam® with other drugs have not been evaluated. It is recommended that CytoGam® be administered separately from other drugs or medications which the patient may be receiving (see DOSING AND ADMINISTRATION section).