Cytogam (cytomegalovirus immune globulin (human))
Last reviewed · Source: First Databank (FDB) drug data
Overview
Cytomegalovirus immune globulin IV (CMV-IGIV) is a specific immune globulin (hyperimmune globulin). CMV-IGIV contains immunoglobulin G (IgG) prepared from plasma of adults selected for high titers of CMV antibody.
Cytomegalovirus immune globulin IV (CMV-IGIV) is used to provide passive immunity to cytomegalovirus (CMV) in certain individuals at risk for primary CMV infection or disease or secondary) CMV disease (reactivation of CMV). CMV-IGIV has been designated an orphan drug by the US Food and Drug Administration (FDA) for the prevention or attenuation of primary CMV disease in immunosuppressed organ transplant recipients. CMV-IGIV is labeled by the FDA for prophylaxis of CMV disease in CMV-seronegative or CMV-seropositive recipients of kidney, liver, lung, pancreas, or heart transplant.
With the exception of CMV-seronegative recipients of kidneys from CMV-seropositive donors, CMV-IGIV prophylaxis should be considered in conjunction with ganciclovir. CMV-IGIV has been used in an attempt to prevent primary or secondary CMV disease in allogeneic bone marrow transplant (BMT) patients+; however, the role of the immune globulin in this patient population is less clearly established than its role in solid organ transplant recipients. CMV-IGIV also has been used in conjunction with ganciclovir for the treatment of CMV pneumonitis+ in transplant recipients, and has been designated an orphan drug by the FDA for use in conjunction with ganciclovir for the treatment of CMV pneumonia in bone marrow transplant recipients.
Generic name: cytomegalovirus immune globulin (human)
Pronunciation: (CMV ih-MYOON GLOB-you-lin)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Cytogam
Indications
The following indications are listed for Cytogam:
- Prevention Of Cmv Disease After Organ Transplant
Also known as: Cytomegalovirus Prophylaxis In Organ Transplantation, Prevention Of Cmv Infection After Organ Transplantation.
Dosing
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Cytomegalovirus immune globulin IV (CMV-IGIV) is administered by IV infusion. CMV-IGIV should not be administered IM or subcutaneously.
CMV-IGIV should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should be colorless and should not be used if turbid. Vials of CMV-IGIV should not be shaken; formation of foam should be avoided. CMV-IGIV contains no preservatives and the manufacturer recommends that vials of the immune globulin be entered only once and that the infusion be initiated within 6 hours and completed within 12 hours after entering the vial. To prevent transmission of hepatitis B infection and/or other infectious agents from one individual to another, a different sterile syringe and needle must be used for each individual who is administered CMV-IGIV.
IV infusions of CMV-IGIV should be administered through an IV line using an administration set that contains in inline filter (pore size 15 mcm) and a controlled-infusion device (i.e., IVAC(R) pump or equivalent) to control the rate of flow. The manufacturer states that a smaller inline membrane filter (0.2 mcm) also may be used during administration of CMV-IGIV. CMV-IGIV should not be diluted prior to IV infusion and preferably should be administered via a separate infusion line. CMV-IGIV may be piggy-backed into a preexisting line containing 0.9% sodium chloride injection or 2.5, 5, 10, or 20% dextrose injection (with or without sodium chloride) provided the dilution of immune globulin does not exceed 1:2 with such fluid. Information on the physical and/or chemical compatibility of CMV-IGIV with other IV infusion fluids or other drugs is not available, and the manufacturer recommends that CMV-IGIV not be admixed with other drugs.
Vital signs should be assessed prior to initiating the CMV-IGIV infusion, midway through the infusion, and after completion of the infusion. Vital signs also should be assessed before any change is made in the rate of administration and closely monitored during and after the change. In addition, renal function, including measurement of BUN, serum creatinine, and urine output, should be assessed before and at appropriate intervals after administration of CMV-IGIV. If renal function decreases, consideration should be given to discontinuing CMV-IGIV.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
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There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
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There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
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There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Animal reproductive studies have not been performed with CMV-IGIV and it is not known whether CMV-IGIV can cause fetal harm when administered to pregnant women. CMV-IGIV should be used during pregnancy only when clearly needed.
The US Public Health Service Advisory Committee on Immunization Practices (ACIP) states there are no known risks for the fetus from use of immune globulin preparations for passive immunization in pregnant women. CMV-IGIV has been used in a limited number of pregnant women with primary CMV infection in an attempt to treat and prevent congenital CMV infection. (See Uses: Congenital or Neonatal CMV Infection.)
Information on the distribution of CMV-IGIV into milk is not available; it is not known if transmission of CMV-IGIV to a nursing infant presents any unusual risk.
No enhanced messaging available.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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