Medical Editor: John P. Cunha, DO, FACOEP
Cytogam [Cytomegalovirus Immune Globulin Intravenous (Human)] is a sterilized solution obtained from pooled human blood that contains the immunoglobulins (or antibodies) to protect against infection from cytomegalovirus and is used to help prevent infection by cytomegalovirus in people who receive an organ transplant. Cytogam may be available in generic form. Common side effects of Cytogam include:
- muscle cramps
- back/joint pain
- and injection site reactions (pain, redness, and swelling)
The maximum recommended total dosage of Cytogam per infusion is 150 mg Ig/kg. Dosage schedule depends on the organ being transplanted. Cytogam may interact with "live" vaccines (e.g., measles, mumps, and rubella or MMR) during and for approximately three months following treatment with CMV IG. Tell your doctor all medications and supplements you use and all vaccines you have recently received. During pregnancy, Cytogam should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Cytogam [Cytomegalovirus Immune Globulin Intravenous (Human)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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;
- 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Cytogam (Cytomegalovirus Immune Globulin Intravenous Human)
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.
The following adverse reactions have been identified and reported during the post-approval use of IGIV products (38):
Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis
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.
Read the entire FDA prescribing information for Cytogam (Cytomegalovirus Immune Globulin Intravenous Human)
© Cytogam Patient Information is supplied by Cerner Multum, Inc. and Cytogam Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.