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Cytogam

"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...

Cytogam

Cytogam®
Cytomegalovirus Immune Globulin Intravenous (Human)

Liquid Formulation
Solvent Detergent Treated

Cytogam

DRUG DESCRIPTION

Cytogam® , Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV), is an immunoglobulin G (IgG) containing a standardized amount of antibody to Cytomegalovirus (CMV). CMV-IGIV is formulated in final vial as a sterile liquid. The globulin is stabilized with 5% sucrose and 1% Albumin (Human). Cytogam® contains no preservative. The purified immunoglobulin is derived from pooled adult human plasma selected for high titers of antibody for Cytomegalovirus (CMV) (1). Source material for fractionation may be obtained from another U.S. licensed manufacturer. Pooled plasma was fractionated by ethanol precipitation of the proteins according to Cohn Methods 6 and 9, modified to yield a product suitable for intravenous administration. A widely utilized solvent-detergent viral inactivation process is also used (2). Certain manufacturing operations may be performed by other firms. Each milliliter contains: 50 ± 10 mg of immunoglobulin, primarily IgG, and trace amounts of IgA and IgM; 50 mg of sucrose; 10 mg of Albumin (Human). The sodium content is 20-30 mEq per liter, i.e., 0.4-0.6 mEq per 20 mL or 1.0-1.5 mEq per 50 mL The solution should appear colorless and translucent.

REFERENCES

1. Snydman DR, McIver J, Leszczynski J, et al. A pilot trial of a novel cytomegalovirus immune globulin in renal transplant recipients. Transplantation 1984;38:553-557.

2. Horowitz B, Wiebe ME, Lippin A, et al. Inactivation of viruses in labile blood derivatives. Transfusion 1985;25:516-522.

What are the possible side effects of CMV IG (Cytogam)?

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...

Read All Potential Side Effects and See Pictures of Cytogam »

What are the precautions when taking cytomegalovirus immune globulin intravenous human (Cytogam)?

See also Warning section.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).

Tell your doctor of any recent or planned immunizations/vaccinations. This...

Read All Potential Precautions of Cytogam »

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

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Cytogam - User Reviews

Cytogam User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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