Efficacy, pharmacokinetics, safety, and tolerability of flebogamma ® 10% DIF, a high-purity human intravenous immunoglobulin, in primary immunodeficiency

Journal of Clinical Immunology

Volumn 30, Issue 2, 2010, Pages 321-329

  Berger, Melvin ^a   Pinciaro, Paul J ^b   Althaus, Arthur ^c   Ballow, Mark ^d   Chouksey, Akhilesh ^e   Moy, James ^f   Ochs, Hans ^g   Stein, Mark ^h  

^a CASE WESTERN RESERVE UNIVERSITY   (United States)

^b Grifols Biologicals Inc   (United States)

^c Kentuckiana Asthma and Allergy Center   (United States)

^d CHILDREN S HOSPITAL OF BUFFALO   (United States)

^e CASE WESTERN RESERVE UNIVERSITY   (United States)

^f RUSH UNIVERSITY MEDICAL CENTER   (United States)

^g UNIVERSITY OF WASHINGTON   (United States)

^h Allergy Associates of the Palm Beaches   (United States)

Author keywords

Clinical trial; Flebogamma 10 DIF; IGIV; Intravenous immune globulin; Nanofiltration; Primary immunodeficiency disease

Indexed keywords

IMMUNOGLOBULIN; IMMUNOGLOBULIN G;

ADOLESCENT; ADULT; AGED; ARTICLE; BACKACHE; BACTERIAL INFECTION; BACTERIAL PNEUMONIA; CELLULITIS; CHILD; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; COMMON VARIABLE IMMUNODEFICIENCY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DRUG EFFICACY; DRUG FEVER; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; HYPOTENSION; IMMUNE DEFICIENCY; IMMUNOTHERAPY; INFECTION RATE; MALE; MYALGIA; NAUSEA; PRESCHOOL CHILD; PRIORITY JOURNAL; RIGOR; SCHOOL CHILD; SINUSITIS; TACHYCARDIA; X LINKED AGAMMAGLOBULINEMIA;

ADOLESCENT; ADULT; AGED; BACTERIAL INFECTIONS; CHILD; DRUG DOSAGE CALCULATIONS; DRUG EVALUATION; FEMALE; HALF-LIFE; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; IMMUNOLOGIC DEFICIENCY SYNDROMES; MALE; MIDDLE AGED;

EID: 77953538938     PISSN: 02719142     EISSN: 15732592     Source Type: Journal    
DOI: 10.1007/s10875-009-9348-y     Document Type: Article

References (28)

1. Berger M. A history of immune globulin therapy, from the Harvard crash program to monoclonal antibodies. Curr Allergy Asthma Rep. 2002;2:368-378
2. Eibl MM. History of immunoglobulin replacement. Immunol Allergy Clin North Am. 2008;28:737-764
3. Outbreak of hepatitis C associated with intravenous immunoglobulin administration - United States, October 1993-June 1994 (1994) MMWR Morb Mortal Wkly Rep 43:505-509
4. Kempf C, Stucki M, Boschetti N. Pathogen inactivation and removal procedures used in the production of intravenous immunoglobulin. Biologicals. 2007;35:35-42.
5. Horowitz B, Wiebe ME, Lippin A, Stryker MH. Inactivation of viruses in labile blood derivatives. 1. Disruption of lipidenveloped viruses by tri-(n-butyl) phosphate detergent combinations. Transfusion. 1985;25:516-522
6. Korneyeva M, Hotta J, Lebing W, Rosenthal RS, Franks L, Petteway SR Jr. Enveloped virus inactivation by caprylate - a robust alternative to solvent detergent treatment in plasma derived intermediates. Biologicals. 2002;30:153-162
7. Louie RE, Galloway CJ, Dumas ML, et al. Inactivation of hepatitis C virus in low pH Intravenous immunoglobulin. Biologicals. 1994;22:13-19
8. Burnouf T, Radosevich M. Nanofiltration of plasma-derived biopharmaceutical products. Haemophilia. 2003;9:24-37.
9. O'Grady J, Losikoff A, Poiley J, Fickett D, Oliver C. Virus removal studies using nanofiltration membranes. Dev Biol Stand. 1996;88:319-326
10. Soluk L, Price H, Sinclair C, Atalla-Mikhail D, Genereux M. Pathogen safety of intravenous Rh immunoglobulin liquid and other immune globulin products: enhanced nanofiltration and manufacturing process overview. Am J Ther. 2008;15:435-443
11. Kumar A, Teuber SS, Gershwin ME. Current perspectives on primary immunodeficiency diseases. Clin Dev Immunol. 2006;13:223-259
12. Berger M. Principles of and advances in immunoglobulin replacement therapy for primary immunodeficiency. Immunol Allergy Clin North Am. 2008;28:413-437
13. Hooper J. intravenous immunoglobulins: evolution of commercial IGIV preparations. Immunol Allergy Clin North Am. 2008;28:765-778
14. Jorquera JI. Flebogamma 5% DIF development: rationale for a new option in intravenous immunoglobulin therapy. Clin Exp Immunol. 2009;157(Suppl 1):17-21.
15. Vlug A, Nieuwenhuys EJ, van Eijk RV, Geertzen HG, van Houte AJ. Nephelometric measurements of human IgG subclasses and their reference ranges. Ann Biol Clin (Paris). 1994;52:561-567
16. US FDACompliance programguidance manual. Chapter 42 - Blood and blood products inspection of source plasma establishments, brokers, testing laboratories and contractors. http://www.fda.gov/ cber/cpg/7342002bld.htm. Accessed 27 December 2008
17. Code of Federal Regulations, Title 21, Volume7. CFR21 Part 640. April 1, 2008
18. Berger M, Flebogamma® 5% DIF® Investigators. A multicenter, prospective, open label, historically controlled clinical trial to evaluate efficacy and safety in primary immunodeficiency disease patients of Flebogamma 5% DIF®, the next generation of Flebogamma. J Clin Immunol. 2007;27:628-633
19. Belda FJ, Otegui M, Caballero S, Domingo N, Díez JM, Gajardo R, et al. Viral safety studies of FlebogammaDIF®. Clin Exp Immunol. 2008;154:209.
20. US FDA. Guidance for industry: safety, efficacy and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary immune deficiency. www.fda.gov/cber/gdlns/ igivimmuno.htm. Accessed 25 March 2009
21. Berger M, Pinciaro PJ, Flebogamma 5% Investigators. Safety, efficacy and pharmacokinetics of Flebogamma 5% for replacement therapy in primary immune deficiency. J Clin Immunol. 2004;24:389-396
22. Heatherington AC, Vinci P, Golde H. A pharmacokinetic/ pharmacodynamic comparison of SAAM II and PC/WinNonlin modeling software. J Pharm Sci. 1998;87:1255-1263 (Pubitemid 28455618)
23. Official Disability Guidelines. http://www.disabilitydurations.com/pr- repmdc.htm. Accessed 25 March 2009
24. Centers for Disease Control and Prevention. FastStats. http:// www.cdc.gov/nchs/fastats. Accessed 25 March 2009
25. Bonagura VR, Marchlewski R, Cox A, Rosenthal DW. Biologic IgG level in primary immunodeficiency disease: the IgG level that protects against recurrent infection. J Allergy Clin Immunol. 2008;122:210-212
26. Daw Z, Padmore R, Neurath D, Cober N, Tokessy M, Desjardins D, et al. Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: a case series analysis. Transfusion. 2008;48:1598-1601
27. Stein MR, Nelson RP, Church JA, Wasserman RL, Borte M, Vermylen C, et al. Safety and efficacy of PrIGIVen®, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J Clin Immunol. 2009;29:137-144
28. Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Transfus Med Rev. 2003;17:241-251