NEW ENGLAND JOURNAL OF MEDICINE         MECHANISMS OF DISEASE   Intravenous Immune Globulin inAutoimmune and Inflammatory D...
Outline   What is IVIG?   FDA-approved indication   Additional approved indication with criteria   National Health Insuran...
What is IVIG?  IVIG is stands for Intravenous Immune Globulin.  IVIG is prepared from plasma pooled from  thousands of hea...
FDA-approved indication   Primary immunodeficiency disease   Chronic lymphocytic leukemia   Pediatric HIV infection   Kawas...
Additional approved indication withcriteria     Neuromuscular disorders     Guillain–Barré syndrome     Myasthenia gravis ...
National Health Insurance (in Taiwan)Criteria for IVIG      1.先天或後天性免疫球蛋白低下症併發嚴重感染時(須附六個月內免疫球蛋白檢查報告)      2.免疫血小板缺乏性紫斑症(IT...
How do Immunoglobulins been produced?Ref: Vanders Human Physiology: The Mechanisms of Body Function, 11e, FIGURE 18-14    ...
How does Immunoglobulin look like?Ref: N Engl J Med 2012;367:2015-25.DOI: 10.1056/NEJMra1009433                           ...
How does Immunoglobulin work?Ref: N Engl J Med 2012;367:2015-25.DOI: 10.1056/NEJMra1009433                                ...
How does Immunoglobulin work?Ref: N Engl J Med 2012;367:2015-25.DOI: 10.1056/NEJMra1009433                                ...
IVIG for Primary Immunodeficiency      Dosage of IVIG for Primary immunodeficiency      disease:      0.2-0.6g /kg each mont...
IVIG for Bone Marrow Transplantation      Dosage of IVIG for allogeneic bone marrow      transplantation:      Initial dos...
IVIG for Kawasaki’s disease     Underlying pathophysiological characteristics of     the disease remain to be clearly defin...
IVIG for Kawasaki’s disease     Decreases in the production of pro-inflammatory     cytokines (e.g., tumor necrosis factor ...
IVIG for Kawasaki disease      Dosage of IVIG for Kawasaki’s disease:      1.6-2g /kg in two to five days      2g /kg for s...
IVIG for ITP  ITP stands for idiopathic thrombocytopenic  purpura.  ITP is primarily a disease of increased peripheral  pl...
IVIG for ITP      Dosage of IVIG for ITP:      2g /kg in two to five daysReF: National Taiwan University Hospital Hsin-Chu ...
IVIG for GBS  GBS stands for Guillain–Barré Syndrome which is a  post-infectious, immune-mediated disease.  The pathophysi...
Ref: Vanders Human Physiology: The Mechanisms of Body Function, 11e, FIGURE 6-2                                           ...
IVIG for GBS  Dosage of IVIG for Guillain–Barré syndrome:  2g /kg in five days                                             ...
IVIG preparation in our hospital   Human Immunoglobulin (TBSF) injection   (6% 3g/50mL/btl)   Cost: $6750 NTD/btl   How su...
Summary  The use of IVIG has been firmly established for the treatment of a wide  variety of autoimmune and inflammatory dis...
Reference:   N Engl J Med 2012;367:2015-25.DOI: 10.1056/NEJMra1009433   Vanders Human Physiology: The Mechanisms of Body F...
Thanks For Your Attention.                             24
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[NTUH Hsin-chu Branch][Department of Pharmacy][2013.01.23 Seminar][IVIG in Autoimmune and Inflammatory Disease]

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[NTUH Hsin-chu Branch][Department of Pharmacy][2013.01.23 Seminar][IVIG in Autoimmune and Inflammatory Disease]

  1. 1. NEW ENGLAND JOURNAL OF MEDICINE MECHANISMS OF DISEASE Intravenous Immune Globulin inAutoimmune and Inflammatory Disease Speaker: Pharmacist Ting-wei Wu Department of Pharmacy Jan. 23rd, 2013 1
  2. 2. Outline What is IVIG? FDA-approved indication Additional approved indication with criteria National Health Insurance (in Taiwan) Criteria for IVIG How do Immunoglobulins been produced? How does Immunoglobulin looks like? How does Immunoglobulin work? IVIG for Primary Immunodeficiency IVIG for Bone Marrow Transplantation IVIG for Kawasaki’s Disease IVIG for Idiopathic Thrombocytopenic Purpura IVIG for Guillain–Barré Syndrome IVIG preparation in our hospital Summary Reference 2
  3. 3. What is IVIG? IVIG is stands for Intravenous Immune Globulin. IVIG is prepared from plasma pooled from thousands of healthy donors. More than a dozen preparations suitable for intravenous administration have been approved by the FDA for the treatment of primary immunodeficiency disease. 3
  4. 4. FDA-approved indication Primary immunodeficiency disease Chronic lymphocytic leukemia Pediatric HIV infection Kawasaki’s disease Allogeneic bone marrow transplantation Chronic inflammatory demyelinating polyneuropathy Multifocal motor neuropathy 4
  5. 5. Additional approved indication withcriteria Neuromuscular disorders Guillain–Barré syndrome Myasthenia gravis Hematologic disorders Autoimmune hemolytic anemia Neonatal alloimmune thrombocytopenia Dermatologic disordersRef: N Engl J Med 2012;367:2015-25.DOI: 10.1056/NEJMra1009433 5
  6. 6. National Health Insurance (in Taiwan)Criteria for IVIG 1.先天或後天性免疫球蛋白低下症併發嚴重感染時(須附六個月內免疫球蛋白檢查報告) 2.免疫血小板缺乏性紫斑症(ITP)病例經傳統治療無效且血小板嚴重低下(< 20,000/ cumm)合併有嚴重出血危及生命者。 3.免疫血小板缺乏性紫斑(ITP)病例合併血小板嚴重低下(< 20,000/cumm)或合併有嚴重 出血而又必須接受緊急手術治療者。 4.先天性免疫不全症之預防性使用,但需有醫學中心之診斷証明。 5.川崎病合乎美國疾病管制中心所訂之診斷標準,限由區域醫院(含)以上教學醫院實施, 並填寫「全民健康保險使用Intravenous Immune Globulin (IVIG) 治療川崎病」申請表 併當月份醫療費用申報。 6.因感染誘發過度免疫機轉反應,而致維生重要器官衰竭,有危及生命之慮者,限由區域醫 院(含)以上有加護病房⼄乙等級以上之教學醫院實施。(93/2/1) 7. 腸病毒感染嚴重患者,且符合行政院衛生署疾病管制局於97年1月修訂之『腸病毒感染 嚴重患者靜脈注射免疫球蛋白之適應症』。(97/5/9)Ref: Bureau of National Health Iinsurance, Department of Health, Executive Yuan 6
  7. 7. How do Immunoglobulins been produced?Ref: Vanders Human Physiology: The Mechanisms of Body Function, 11e, FIGURE 18-14 7
  8. 8. How does Immunoglobulin look like?Ref: N Engl J Med 2012;367:2015-25.DOI: 10.1056/NEJMra1009433 8
  9. 9. How does Immunoglobulin work?Ref: N Engl J Med 2012;367:2015-25.DOI: 10.1056/NEJMra1009433 9
  10. 10. How does Immunoglobulin work?Ref: N Engl J Med 2012;367:2015-25.DOI: 10.1056/NEJMra1009433 10
  11. 11. IVIG for Primary Immunodeficiency Dosage of IVIG for Primary immunodeficiency disease: 0.2-0.6g /kg each monthReF: National Taiwan University Hospital Hsin-Chu Branch Formulary, 101 1st ED, p174 11
  12. 12. IVIG for Bone Marrow Transplantation Dosage of IVIG for allogeneic bone marrow transplantation: Initial dose: 0.5g /kg /weekReF: National Taiwan University Hospital Hsin-Chu Branch Formulary, 101 1st ED, p174 12
  13. 13. IVIG for Kawasaki’s disease Underlying pathophysiological characteristics of the disease remain to be clearly defined. The anti-inflammatory potential of IVIG in patients with Kawasaki’s disease has been well described. After a single intravenous infusion of immune globulin, fever often abates, with concomitant reductions in several inflammatory markers.Ref: N Engl J Med 2012;367:2015-25.DOI: 10.1056/NEJMra1009433 13
  14. 14. IVIG for Kawasaki’s disease Decreases in the production of pro-inflammatory cytokines (e.g., tumor necrosis factor α [TNF-α], interleukin-1α, and interleukin-6) Down-regulation of adhesion molecule and chemokine and chemokine-receptor expression Neutralization of super-antigensRef: N Engl J Med 2012;367:2015-25.DOI: 10.1056/NEJMra1009433 14
  15. 15. IVIG for Kawasaki disease Dosage of IVIG for Kawasaki’s disease: 1.6-2g /kg in two to five days 2g /kg for single doseReF: National Taiwan University Hospital Hsin-Chu Branch Formulary, 101 1st ED, p174 15
  16. 16. IVIG for ITP ITP stands for idiopathic thrombocytopenic purpura. ITP is primarily a disease of increased peripheral platelet destruction. Most patients have immunoglobulin G autoantibodies to specific membrane glycoproteins on the platelet surface. 16
  17. 17. IVIG for ITP Dosage of IVIG for ITP: 2g /kg in two to five daysReF: National Taiwan University Hospital Hsin-Chu Branch Formulary, 101 1st ED, p174 17
  18. 18. IVIG for GBS GBS stands for Guillain–Barré Syndrome which is a post-infectious, immune-mediated disease. The pathophysiologic mechanism of GBS can be typified by C jejuni infections. Immune responses against lipopolysaccharide antigens in the capsule of C jejuni. Antibodies cross-react with ganglioside GM1 in myelin, resulting in the immunologic damage to the peripheral nervous system. 18
  19. 19. Ref: Vanders Human Physiology: The Mechanisms of Body Function, 11e, FIGURE 6-2 19
  20. 20. IVIG for GBS Dosage of IVIG for Guillain–Barré syndrome: 2g /kg in five days 20
  21. 21. IVIG preparation in our hospital Human Immunoglobulin (TBSF) injection (6% 3g/50mL/btl) Cost: $6750 NTD/btl How supply: IVIG dilutes with 50mL D5W or NS Intravenous infusion; infusion rate: 1 mL/min for first 15 min 3-4 mL/min for max speed 21
  22. 22. Summary The use of IVIG has been firmly established for the treatment of a wide variety of autoimmune and inflammatory diseases, either as adjunctive therapy or as first-line therapy in some conditions, such as Kawasaki’s disease. Results in animal models have not been entirely consistent and easy to translate to human disease. Double-blind, placebo-controlled trials remain essential to establish the efficacy of this intervention a variety of disease states. IVIG therapy, especially at doses of 2 g per kilogram per month, is expensive, and with expanding use there are concerns about present and future supplies, especially if the donor pool decreases or is limited by safety issues and increased pathogen screening of donors of the source plasma. Attempts to bioengineer a protein with immunomodulatory activities similar to those of native IgG should be a priority if we are to sustain this approach to disease modification. The successes with IVIG witnessed over the past few decades are just the beginning. Now the real work needs to begin. 22
  23. 23. Reference: N Engl J Med 2012;367:2015-25.DOI: 10.1056/NEJMra1009433 Vanders Human Physiology: The Mechanisms of Body Function, 11e; ISBN 978-986-157-640-4 National Taiwan University Hospital Hsin-Chu Branch Formulary, 101 1st ED 23
  24. 24. Thanks For Your Attention. 24

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