L-Proline-Stabilized Human IgG: Privigen^® 10% for Intravenous Use and Hizentra^® 20% for Subcutaneous Use

• Berger M : A history of immune globulin therapy from the Harvard crash program to monoclonal antibodies.Curr. Allergy Asthma Rep.2 , 368–378 (2002).
   PubMedGoogle Scholar
• Eibl M : History of immunoglobulin replacement.Immunol. Allergy Clin. North Am.28 , 737–764 (2008).
   PubMed Web of Science ®Google Scholar
• Barandun S , KistlerP, JeunetF et al.: Intravenous administration of human γ-globulin.Vox Sang.7 , 157–174 (1962).
   PubMed Web of Science ®Google Scholar
• Alving B , TankersleyDL, MasonBL et al.: Contact activated factors: contaminants of immunoglobulin preparations with coagulant and vasoactive properties.J. Lab. Clin. Med.96 , 334–346 (1980).
   PubMed Web of Science ®Google Scholar
• IUIS Working Group: Appropriate uses of human immunoglobulin in clinical practice: memorandum of an IUIS/WHO meeting. Bull World Health Organ.60 , 43–47 (1982).
   PubMed Web of Science ®Google Scholar
• Hooper JA : Intravenous immunoglobulins: evolution of commercial preparations.Immunol. Allergy Clin. North Am.28 , 765–778 (2008).
   PubMed Web of Science ®Google Scholar
• Ochs HD , BuckleyRH, Pirofsky,B et al.: Safety and acceptability of intravenous immune globulin in 10% maltose.LancetII , 1158–1159 (1982).
   Google Scholar
• Shehata N , PaldaV, BowenT et al.: The use of immunoglobulin therapy for patients with primary immune deficiency: an evidence-based practice guideline.Transfus. Med. Rev.24(Suppl. 1) , S28–S50 (2010).
   PubMed Web of Science ®Google Scholar
• Durandy A , KaveriSV, KuijpersTW et al.: Intravenous immunoglobulins –understanding properties and mechanisms.Clin. Exp. Immunol.158(Suppl. 1) , S2–S13 (2009).
   PubMed Web of Science ®Google Scholar
• Gold R , StangelM, DalakasMC: Drug insight: the use of intravenous immunoglobulin in neurology – therapeutic considerations and practical issues.Nat. Clin. Pract. Neurol.3(1) , 36–44 (2007).
   PubMedGoogle Scholar
• Orange JS , HossnyEM, WeilerCR et al.: Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology.J. Allergy Clin. Immunol.117(Suppl. 4) , S525–S53 (2006).
   PubMed Web of Science ®Google Scholar
• Berger M : Principles of, and advances in, immunoglobulin replacement therapy for primary immunodeficiency.Immunol. Allergy Clin. North Am.28 , 413–437 (2008).
   PubMed Web of Science ®Google Scholar
• Radosevich M , BurnoufT: Intravenous Immunoglobulin G: trends in production methods, quality control and quality assurance.Vox Sang.98 , 12–28 (2010).
   PubMed Web of Science ®Google Scholar
• Stucki M , BoschettiN, SchaferW et al.: Investigations of prion and virus safety of a new liquid IVIG product.Biologicals36 , 239–247 (2008).
   PubMed Web of Science ®Google Scholar
• Cramer M , FreiR, SebaldA et al.: Stability over 36 months of a new liquid 10% polyclonal immunoglobulin product (IgPro10, Privigen®) stabilized with L-proline.Vox Sang.96 , 219–225 (2009).
   PubMed Web of Science ®Google Scholar
• Biesert L : Virus validation studies of immunoglobulin preparations.Clin. Exp. Rheum.14 (Suppl. 15) , S47–S52 (1996).
   PubMed Web of Science ®Google Scholar
• Kahwaji J , BarkerE, PepkowitzS et al.: Acute hemolysis after high-dose intravenous immunoglobulin therapy in highly HLA sensitized patients.Clin. J. Am. Soc. Nephrol.4 , 1993–1997 (2009).
   PubMed Web of Science ®Google Scholar
• Spycher M , BolliR, HodlerC et al.: Well-tolerated liquid intravenous immunoglobulin preparations (IVIG) have a low IgG-Dimer content.J. Autoimmun.96 (Suppl. 1) , 96 (1996).
   Google Scholar
• Barandun S , KistlerP, JeunetE, IslikerH: Intravenous administration of human γ-globulin.Vox Sang.7 , 157–174 (1962).
   PubMed Web of Science ®Google Scholar
• Bleeker WK , TeelingJL, VerhoevenAJ et al.: Vasoactive side effects of intravenous immunoglobulin preparations in a rat model and their treatrment with recombinant platelet activating factor acetylhydrolase.Blood95 , 1856–1861 (2000).
   PubMed Web of Science ®Google Scholar
• Kroez M , KanzyEJ, GronskiP, DickneiteG: Hypotension with intravenous immunoglobulin therapy: importance of pH and dimer formation.Biologicals31 , 277–286 (2003).
   PubMed Web of Science ®Google Scholar
• Tankersley DL , PrestonMS, FinlaysonJS: Immunoglobulin-G dimer: an idiotype–anti-idiotype complex.Mol. Immunol.25 , 41–48 (1988).
   PubMed Web of Science ®Google Scholar
• Schwartz RS : Overview of the biochemistry and safety of a new native intravenous γ-globulin, IGIV, pH 4.25.Am. J. Med.83(4A) , 46–51 (1987).
   PubMed Web of Science ®Google Scholar
• Bolli R , WoodtliK, BartschlM et al.: L-Proline reduces IgG dimer content and enhances the stability of IVIG solutions.Biologicals38 , 150–157 (2010).
   PubMed Web of Science ®Google Scholar
• Spycher M , MatozanK, MinnigK et al.: In vitro comparison of the complement-scavenging capacity of different intravenous immunoglobulin preparationsVox Sang.97(4) , 348–354 (2009).
   PubMed Web of Science ®Google Scholar
• Bonilla FA : Pharmacokinetics of immunoglobulin administered via intravenous or subcutaneous routes.Immunol. Allergy Clin. N. Amer.28 , 803–819 (2008).
   PubMed Web of Science ®Google Scholar
• Berger M : Subcutaneous administration of IgG.Immunol. Allergy Clin. N. Am.28 , 779–802 (2008).
   PubMed Web of Science ®Google Scholar
• Wasserman RL , ChurchJA, PeterHH et al.: Pharmacokinetics of a new 10% intravenous immunoglobulin in patients receiving replacement therapy for primary immunodeficiencyEur. J. Pharm. Sci.37 , 272–278 (2009).
   PubMed Web of Science ®Google Scholar
• Stein MR , NelsonRP, ChurchJA et al.: Safety and efficacy of Privigen, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary antibody deficiencies.J. Clin. Immunol.29 , 137–144 (2009).
   PubMed Web of Science ®Google Scholar
• CSL Behring: Privigen® product monograph, 2008. Available from: CSL Behring LLC., 1020 First Ave, King of Prussia, PA, USA, 19406
   Google Scholar
• Gardulf A , NicolayU, AsensioO et al.: Rapid subcutaneous IgG-replacement therapy is effective and safe in children and adults with primary immunodeficiencies: a prospective, multinational study.J. Clin. Immunol.26 , 177–185 (2006).
   PubMed Web of Science ®Google Scholar
• Skoda-Smith S , TorgersonTR, OchsHD: Subcutaneous immunoglobulin replacement therapy in the treatment of patients with primary immunodeficiency diseaseTher. Clin. Risk Manag.6 , 1–10 (2010).
   PubMed Web of Science ®Google Scholar
• Gardulf A , NicolayU, MathD: Children and adults with primary antibody deficiencies gain quality of life by subcutaneous IgG self-infusions at home.J. Allergy Clin. Immunol.114(4) , 936–942 (2004).
   PubMed Web of Science ®Google Scholar
• Nicolay U , KiesslingP, BergerM et al.: Health-related quality of life and treatment satisfaction in North American patients with primary immunedeficiency diseases receiving subcutaneous IgG self-infusions at home.J. Clin. Immunol.26(1) , 65–72 (2006).
   PubMed Web of Science ®Google Scholar
• Desai SH , ChoukseyA, PollJ: A pilot study of equal doses of 10% IGIV given intravenously or subcutaneously.J. Allergy Clin. Immunol.124(4) , 854–856 (2009).
   PubMed Web of Science ®Google Scholar
• Jolles S , BernatowskaE, DeGraciaJ et al.: Efficacy and safety of IgPro20 in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy.Clin. Immunol. (2010) (Epub ahead of print).
   Google Scholar
• Wasserman RL , IraniAM, TracyJ et al.: Pharmacokinetics and safety of subcutaneous immune globulin (human), 10% caprylate/chromatography purified in patients with primary immunodeficiency disease.Clin. Exp. Immunol.161(3) , 518–26 (2010).
   PubMed Web of Science ®Google Scholar
• Lucas M , LeeM, LortanJ et al.: Infection outcomes in patients with common variable immunodeficiency disorders: relationship to immunoglobulin therapy over 22 years.J. Allergy Clin. Immunol.125(6) , 1354–1360 (2010).
   PubMed Web of Science ®Google Scholar
• Orange JS , GrossmanWJ, NavickisRJ, WilkesMM: Impact of trough IgG on pneumonia incidence in primary immunodeficiency: a meta-analysis of clinical studies.Clin. Immunol.161(3) , 518–526 (2010).
   Google Scholar
• Hagan JB , FasanoMB, SpectorS: Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency.J. Clin. Immunol.30(5) , 734–745 (2010).
   PubMed Web of Science ®Google Scholar
• Church JA , BorteM, TakiH et al.: Efficacy and safety of privigen in children and adolescents with primary immunodeficiency.Pediatr. Asthma Allergy Immunol.22 , 53–62 (2009).
   Google Scholar
• Robak T , SalamaA, KovalevaL et al.: Efficacy and safety of Privigen, a novel liquid intravenous immunoglobulin formulation, in adolescent and adult patients with chronic immune thrombocytopenic purpura.Hematology14(4) , 227–236 (2009).
   PubMed Web of Science ®Google Scholar
• Sleasman JW , DuffCM, DunawayT et al.: Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates.J. Clin. Immunol.30(3) , 442–448 (2010).
   PubMed Web of Science ®Google Scholar
• Pierce LR , JainN: Risks associated with the use of intravenous immunoglobulin.Transfus. Med. Rev.17(4) , 241–251 (2003).
   PubMed Web of Science ®Google Scholar
• Misbah S , SturzeneggerMH, BorteM et al.: Subcutaneous immunoglobulin: opportunities and outlook.Clin. Exp. Immunol.158(Suppl. 1) , 51–59 (2009).
   PubMed Web of Science ®Google Scholar

Websites

• WHO guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products WHO Technical Reports Series (TRS) No. 924. Annex 4 (2004) www.who.int/bloodproducts/publications/WHO_TRS_924_A4.pdf (Accessed 22November2010)
   Google Scholar
• Online Mendelian Inheritance in Man (OMIM): hyperprolinemia, type I; and hyperprolinemia, type II www.ncbi.nlm.nih.gov/omim/239500,www.ncbi.nlm.nih.gov/omim/239510 respectively (Accessed 22November2010)
   Google Scholar
• FDA/CBER: STN 125350/0: clinical pharmacology review Link (Accessed 22November2010)
   Google Scholar
• Hizentra final memo: nonclinical pharmacology/toxicity Link (Accessed 22November2010)
   Google Scholar
• ‘Pharmacokinetics‘ in Vivaglobin, summary basis for approval Link (Accessed 22November2010)
   Google Scholar
• US FDA: Guidance for industry: safety, efficacy and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm072130.htm (Accessed 22November2010)
   Google Scholar