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Babybig (Botulism Immune Globulin) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

  • Admixtures of BabyBIG with other drugs have not been evaluated. It is recommended that BabyBIG be administered separately from other drugs or medications that the patient may be receiving [ see DOSAGE AND ADMINISTRATION (2) ].
  • Antibodies present in immune globulin preparations may interfere with the immune response to live virus vaccines such as polio, measles, mumps, and rubella; THEREFORE, VACCINATION WITH LIVE VIRUS VACCINES SHOULD BE DEFERRED UNTIL APPROXIMATELY THREE OR MORE MONTHS AFTER ADMINISTRATION OF BabyBIG. If such vaccinations were given shortly before or after BabyBIG administration, revaccination may be necessary.

OVERDOSAGE

Although limited data are available, clinical experience with other immunoglobulin preparations suggests that the major manifestations would be those related to volume overload.[1]

CONTRAINDICATIONS

  • As with other immunoglobulin preparations, BabyBIG should not be used in individuals with a prior history of severe reaction to other human immunoglobulin preparations.[1-4]
  • Individuals with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to the subsequent administration of blood products that contain immunoglobulin A.

REFERENCES

  1. Cytogam®, cytomegalovirus immune globulin intravenous (human) (CMV-IGIV). In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:1861-1863.
  2. Immune globulin intravenous (human) Iveegam En IGIV. In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:816-820.
  3. Immune globulin intravenous (human) (IGIV) Gammagard® S/D. In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:812-815.
  4. Immune globulin intravenous (human) Sandoglobulin® lyophilized preparation. In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:2210-2213.
  5. Perazella MA, Cayco AV. Acute renal failure and intravenous immune globulin: sucrose nephropathy in disguise? Am J Ther 1998; 5:399-403.
  6. Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after intravenous immune globulin therapy: a report of two cases and an analysis of the literature. J Am Soc Nephrol 1997; 8:1788-1793.
  7. Important Drug Warning ("Dear Doctor") letter. Center for Biologics Evaluation and Research, Food and Drug Administration, 1998.
  8. Denepoux S, et al. Molecular characterization of human IgG monoclonal antibodies specific for major birch pollen allergen Bet v 1. Anti-allergen IgG can enhance the anaphylactic reaction. FEBS Lett 2000; 465:39-46.
  9. Burks AW, Sampson HA, Buckley RH. Anaphylactic reactions after gamma globulin administration in patients with hypogammaglobulinemia. Detection of IgE antibodies to IgA. N Engl J Med 1986; 314:560-564.
  10. Sekul EA, Cupler EJ, Dalakas MC. Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: frequency and risk factors. Ann Intern Med 1994; 121:259-262.
  11. Kato E, Shindo S, Eto Y, et al. Administration of immune globulin associated with aseptic meningitis. JAMA 1988; 259:3269-3270.
  12. Casteels-Van Daele M, Wijndaele L, Hunninck K. Intravenous immunoglobulin and acute aseptic meningitis. N Engl J Med 1990; 323:614-615.
  13. Scribner C, Kapit R, Philips E, Rickels N. Aseptic meningitis and intravenous immunoglobulin therapy. Ann Intern Med 1994; 121:305-306.
  14. Arnon SS, Schechter R, Maslanka SE, Jewell NP, Hatheway CL. Human botulism immune globulin for the treatment of infant botulism. N Engl J Med 2006; 354:462-471.
  15. Arnon SS. Creation and development of the public service orphan drug Human Botulism Immune Globulin. Pediatrics 2007; 119:785-789.
  16. Long SS, Gajewski JL, Brown LW, Gilligan PH. Clinical, laboratory, and environmental features of infant botulism in southeastern Pennsylvania. Pediatrics 1985; 75:935-941.
  17. Schreiner MS, et al. Infant botulism: a review of 12 years' experience at the Children's Hospital of Philadelphia. Pediatrics 1991; 87:159-165.
  18. Wilson R, et al. Clinical characteristics of infant botulism in the United States: a study of the non-California cases. Pediatr Infect Dis 1982; 1:148-150.
  19. Anderson TD, et al. Airway complications of infant botulism: ten-year experience with 60 cases. Otolaryngol Head Neck Surg 2002; 126:234-239.
  20. Arnon SS. Infant botulism. In: Textbook of Pediatric Infectious Diseases. 5th ed. Philadelphia: WB Saunders 2004; 1758-1766.
  21. Snydman DR, Werner BG, Tilney NL, et al. Final analysis of primary cytomegalovirus disease prevention in renal transplant recipients with cytomegalovirus immune globulin: comparison of the randomized and open label trials. Transplant Proc 1991; 23:1357-1360.
  22. Tseng-Ong L, Mitchell WG. Infant botulism: 20 years' experience at a single institution. J Child Neurol 2007; 22:1333-1337.
  23. Underwood K, Rubin S, Deakers T, Newth C. Infant botulism: A 30-year experience spanning the introduction of botulism immune globulin intravenous in the intensive care unit at Childrens Hospital Los Angeles. Pediatrics 2007; 120:e1380-e1385.
  24. Siber GR, Syndman DR. Use of immune globulins in the prevention and treatment of infections. Curr Clin Top Infect Dis 1992; 12:208-256.
  25. Berkman SA, Lee ML, Gale RP. Clinical uses of intravenous immunoglobins. Ann Intern Med 1990; 112:278-292.
  26. Bossell J, et al. Safety of therapeutic immune globulin preparations with respect to transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus infection. Morb Mortal Wkly Rep 1986; 35:231-233.
  27. Wells MA, Wittek AE, Epstein JS, et al. Inactivation and partition of human T-cell lymphotrophic virus, type III, during ethanol fractionation of plasma. Trans 1986; 26:210-213.
  28. Horowitz B, Wiebe ME, Lippin A, Stryker MH. Inactivation of viruses in labile blood derivatives. I. Disruption of lipid-enveloped viruses by tri(n-butyl)phosphate detergent combinations. Transfusion 1985; 25:516-522.
  29. Edwards CA, Piet MPJ, Chin S, Horowitz B. Tri(n-butyl) phosphate/detergent treatment of licensed therapeutic and experimental blood derivatives. Vox Sang 1987; 52:53-59.
  30. Paton JC, Lawrence AL, Steven IM. Quantitation of Clostridium botulinum organisms and toxin in feces and presence of Clostridium botulinum toxin in the serum of an infant with botulism. J Clin Microbiol 1983; 17:13-15.
  31. Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001; 41: 264-268.

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