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Cytogam (Cytomegalovirus Immune Globulin Intravenous (Human)) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS:

Antibodies present in immune globulin preparations 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 DOSAGE AND ADMINISTRATION section).

OVERDOSAGE

Although few data are available, clinical experience with other immunoglobulin preparations suggests that the major manifestations would be those related to volume overload.

CONTRAINDICATIONS

CytoGam® should not be used in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations. Persons with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to subsequent administration of blood products that contain immunoglobulin A, including CytoGam®.

REFERENCES

  1. Snydman DR, Mclver J, Leszczynski J, et al. A pilot trial of a novel cytomegalovirus immune globulin in renal transplant recipients. Transplantation 38:553-557, 1984.
  2. Horowitz B, Wiebe ME, Lippin A, et al. Inactivation of viruses in labile blood derivatives. Transfusion; 25:516-522, 1985.
  3. Snydman DR, Werner BG, Heinze-Lacey BH, et al. Use of cytomegalovirus immune globulin to prevent cytomegalovirus disease in renal transplant recipients. NEJM 317:1049-1054, 1987.
  4. Snydman DR, Werner BG, Dougherty NN, et al. Cytomegalovirus Immune Globulin prophylaxis in liver transplantation. A randomized, double-blind, placebo-controlled trial. Ann Int Med 119:984-991, 1993.
  5. Falagas ME, Snydman DR, Ruthazer R, et al. Cytomegalovirus Immune Globulin (CMVIG) prophylaxis is associated with increased survival after orthotopic liver transplantation. Clin Transplantation, 11:432-437, 1997.
  6. Snydman DR, Werner BG, Tilney NL, et al. A final analysis of primary cytomegalovirus disease prevention in renal transplant recipients with a cytomegalovirus immune globulin: Comparison of randomized and open-label trials. Transplant Proceed 23:1357-1360, 1991.
  7. Snydman DR, Werner BG, Dougherty NN, et al. A further analysis of the use of Cytomegalovirus Immune Globulin in orthotopic liver transplant patients at risk for primary infection. Transplant Proceed 26, suppl 1:23-27, 1994.
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  10. Snydman DR. Combined CMV-IGIV and ganciclovir prophylaxis in CMV seronegative transplant recipients from CMV seropositive donors. Report on file, MedImmune, Inc.
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  13. Bossell, et al. Safety of therapeutic immune globulin preparations with respect to transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus infection. MMWR vol. 35:231-233, April 11, 1996.
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  32. Reinhart WH, Berchtold PE. Effect of high dose intravenous immunoglobulin therapy on blood rheology. Lancet; 339:662-664, 1992.
  33. Kessary-Shoham H, Levy Y, Shoenfeld Y, Lorber M, Gershon H. In vivo administration of intravenous immunoglobulin (IVIg) can lead to enhanced erythrocyte sequestration. J. Autoimmune; 13:129-135, 1999.
  34. Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion; 41:264-268, 2001.
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  37. Wolberg AS, Kon RH, Monroe DM, Hoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J. Hematol; 65:30-34, 2000.
  38. Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Trans Med Rev; 17:241-251, 2003.

For additional information concerning Cytomegalovirus Immune Globulin Intravenous (Human) contact:

Professional Services

MedImmune, Inc.

Gaithersburg, MD 20878, USA

1-800-949-3789

Manufactured by:

MASSACHUSETTS PUBLIC HEALTH

BIOLOGIC LABORATORIES

Boston, Massachusetts 02130, USA

US Govt. License No. 64

Revised January 2004

Marketed by:

MedImmune, Inc.

Gaithersburg, MD 20878, USA

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