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Gammaplex (Human Immunoglobulin G) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Passive transfer of antibodies may transiently interfere with the immune response to live virus vaccines such as measles, mumps, rubella and varicella.11,12 Inform the immunizing physician of recent therapy with Gammaplex so that appropriate measures may be taken (see Patient Counseling Information [17] ).

CONTRAINDICATIONS

  • Gammaplex is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
  • Gammaplex is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.

REFERENCES

  1. Gupta N, Ahmed I, Nissel-Horowitz S, Patel D, Mehrotra B. Intravenous gammaglobulin-associated acute renal failure. Am J Hematol 2001; 66:151-152.
  2. Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology 1994; 44:223-226.
  3. Woodruff RK, Grigg AP, Firkin FC, Smith IL. Fatal thrombotic events during treatment of autoimmune thrombocytopenia with intravenous immunoglobulin in elderly patients. Lancet 1986;2: 217-218.
  4. Gabor EP. Meningitis and skin reaction after intravenous immune globulin therapy. Ann Intern Med 1997; 127:1130.
  5. Copelan EA, Strohm PL, Kennedy MS, Tutschka PJ. Hemolysis following intravenous immune globulin therapy. Transfusion 1986; 26:410-412.
  6. Thomas MJ, Misbah SA, Chapel HM, Jones M, Elrington G, Newsom-Davis J. Hemolysis after high-dose intravenous Ig. Blood 1993; 15:3789.
  7. Wilson JR, Bhoopalam N, Fisher M. Hemolytic anemia associated with intravenous immunoglobulin. Muscle Nerve 1997; 20:1142-1145.
  8. 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 Autoimmun 1999; 13:129-135.
  9. Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001; 41:264-268.
  10. Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Trans Med Rev 2003; 17:241-251.
  11. Siber GA, Werner BG, Halsey NA, Reid R, Almeido-Hill J, Garrett SC, Thompson C, Santosham M. Interference of immune globulin with measles and rubella immunization. J Pediatr 1993; 122:204-211.
  12. Salisbury D, Ramsay M, Noakes K, eds. Immunisation against infectious disease. The Stationery Office (TSO), London: UK Department of Health, 2009; p426,
  13. Hammarstr¶m L, Smith CIE. Placental transfer of intravenous immunoglobulin. Lancet 1986; 1:681.
  14. Sidiropoulos D, Herrmann U, Morell A, von Muralt G, Barandun S. Transplacental passage of intravenous immunoglobulin in the last trimester of pregnancy. J Pediatr 1986; 109:505-508.
  15. Wood P, Stanworth S, Burton J, Jones A, Peckham DG, Chapel H. Recognition, clinical diagnosis and management of patients with primary antibody deficiencies: a systematic review. Clin Exp Immunol 2007; 149:410-423.
  16. Simon H, Sp¤th P. IVIG — Mechanisms of action. Allergy 2003; 58(7):543-52.
  17. Center for Biologics Evaluation and Research. Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; July, 2008.

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