- 1. Data on File. Available from CSL Behring as DOF PVG-002.
- 2. Immune Deficiency Foundation (IDF). About Primary Immunodeficiencies. http://primaryimmune.org/about-primary-immunodeficiencies. Accessed August 17, 2016.
- 3. Immune Deficiency Foundation (IDF). Specific Disease Types. http://primaryimmune.org/about-primary-immunodeficiencies/specific-disease-types/. Accessed August 17, 2016.
- 4. Immune Deficiency Foundation (IDF). Immunoglobulin Therapy and Other Medical Therapies for Antibody Deficiencies. http://primaryimmune.org/treatment-information/immunoglobulin-therapy. Accessed August 17, 2016.
- 5. Berger M. Choices in IgG replacement therapy for primary immune deficiency diseases: subcutaneous IgG vs. intravenous IgG and selecting an optimal dose. Curr Opin Allergy Clin Immunol. 2011;11(6):532-538.
- 6. Siegel J. IVIg Medication Safety: A Stepwise Guide to Production Selection and Use. Pharm Pract News. Dec 2010.
- 7. Siegel J. Immune Globulins: Therapeutic, Pharmaceutical, Cost, and Administrative Considerations. Pharm Pract News. Jan 2010.
- 8. US Dept of Health and Human Services. National Institutes of Health. National Heart, Lung, and Blood Institute. What is immune thrombocytopenia? http://www.nhlbi.nih.gov/health/health-topics/topics/itp/. Accessed August 17, 2016.
- 9. Neunert C, Lim W, Crowther M, et al. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;117(16):4190-4207.
- 10. Robak T, Salama A, Kovaleva L, et al. Efficacy and safety of Privigen, a novel liquid intravenous immunoglobulin formulation, in adolescent and adult patients with chronic immune thrombocytopenic purpura. Hematology. 2009;14(4):227-236.
- 11. US Dept of Health and Human Services. National Institutes of Health. National Heart, Lung, and Blood Institute. How is Immune Thrombocytopenia (ITP) Treated? http://www.nhlbi.nih.gov/health/health-topics/topics/itp/treatment. Accessed August 17, 2016.
- 12. Stein MR, Nelson RP, Church JA, et al. Safety and efficacy of Privigen®, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J Clin Immunol. 2009;29(1):137-144.
- 13. FDA Guidance for Industry “Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency,” June, 2008. Available at http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm078526.pdf.
- 14. National Institutes of Health: ClinicalTrials.gov. Safety and efficacy of intravenous immunoglobulin IgPro10 in patients with primary immunodeficiencies. https://clinicaltrials.gov/ct2/show/NCT00322556?term=NCT00322556&rank=1. Accessed May 31, 2016.
- 15. Cramer M, Frei R, Sebald A, et al. Stability over 36 months of a new liquid 10% polyclonal immunoglobulin product (IgPro10, Privigen®) stabilized with L-proline. Vox Sang. 2009;(96):219-225.
- 16. Bolli R, Woodtli K, Bärtschi M, et al. L-Proline reduces IgG dimer content and enhances the stability of intravenous immunoglobulin (IVIG) solutions. Biologicals. 2010;(38):150-157.
- 17. Hagan JB, Wasserman RL, Baggish JS, et al. Safety of L-proline as a stabilizer for immunoglobulin products. Expert Rev Clin Immunol. 2012;8(2):169-178.
- 18. Sun A, Teschner W, Yel L. Improving patient tolerability in immunoglobulin treatment: focus on stabilizer effects. Expert Rev Clin Immunol. 2013;9(6):577-587.
- 19. Simon HU, Späth PJ. IVIG mechanisms of action. Allergy. 2003;(58):543-552.
- 20. Maddur MS, Lacroix-Desmazes S, Bayry J, Kaveri SV. Intravenous polyclonal immunoglobulin in autoimmune diseases: clinical indications and mechanisms of action. Drug Discov Today Thera Strateg; Autoimmun. 2009;6(1):5-11.
- 21. Imbach P, Lazarus AH, Kühne T. Intravenous immunoglobulins induce potentially synergistic immunomodulations in autoimmune disorders. Vox Sang. 2009;(98)(3 pt 2):385-394.
- 22. US Department of Health & Human Services, Centers for Medicare & Medicaid Services. International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). 2016.616-617.
- 23. American Medical Association. Medicine/hydration, therapeutic, prophylactic, diagnostic injections and infusions, and chemotherapy. In: American Medical Association, ed. CPT 2016. Chicago, IL: American Medical Association; 2016:650-651.
- 24. HCPCS Level II Expert. In: American Academy of Professional Coders. Salt Lake City, Utah: AAPC; 2016.
- 25. HIPAA space healthcare procedure coding system codes lookup S9338. http://www.hipaaspace.com/Medical_Billing/Coding/Healthcare_Common_Procedure_Coding_System/HCPCS_Codes_Lookup.aspx. Accessed June 20, 2017.
- 26. Boyle JM, Buckley RH. Population prevalence of diagnosed primary immunodeficiency diseases in the United States. J Clin Immunol. 2007;(27):497-502.
You are now leaving the current website.
Do you want to continue?