Cytomegalovirus Immune Globulin IV (Intravenous-Human)

Table of contents

  • Brand Names
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Unlabeled Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Genes that may be involved
  • Drug Interactions
  • Dosage
  • Special Considerations

Brand Names

Europe

Belgium: Ivegam-CMV; Czech Republic: Cytotect; Germany: Cytotect; Hungary: Cytotect; Italy: Cytotect; Luxembourg: Ivegam-CMV; Netherlands: Megalotect; Poland: Cytotect; Portugal: Megalotect; Slovakia: Cytotect.

North America

Canada: CytoGam; USA: CytoGam.

Latin America

Argentina: Citax F, Megalotect.

Drug combinations

Chemistry

Pharmacologic Category

Serums; Immune Globulin. (ATC-Code: J06BB09).

Mechanism of action

Preparation of immunoglobulin G derived from pooled healthy blood donors with a high titer of CMV antibodies. Administration provides a passive source of antibodies against CMV.

Therapeutic use

Prophylaxis of CMV disease associated with kidney, lung, liver, pancreas, and heart transplants. Concomitant use with ganciclovir in organ transplants (other than kidney) from CMV seropositive donors to CMV seronegative recipients.

Pregnancy and lactiation implications

Animal reproductive studies not 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. Excretion in breast milk unknown.

Unlabeled use

Adjunct therapy in the treatment of CMV disease in immunocompromised patients.

Contraindications

Hypersensitivity to CMV-IGIV, other immunoglobulins, or any component of the formulation. Immunoglobulin A deficiency.

Warnings and precautions

Hypersensitivity and anaphylactic reactions can occur. After use of I.V. immune globulin administration, antiglobulin hemolysis, aseptic meningitis syndrome, noncardiogenic pulmonary edema, and thrombotic events reported. Acute renal dysfunction (increased serum creatinine, oliguria, acute renal failure) can occur. Use with caution in the elderly, renal disease, diabetes mellitus, volume depletion, sepsis, paraproteinemia, and nephrotoxic medications due to risk of renal dysfunction. Use with caution in patients >65 years of age. Product is stabilized with albumin or sucrose. May potentially contain infectious agents which could transmit disease (it is a product of human plasma).

Information

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