Immunologic Agents : Passive Immunity (Antiserums) : Antiserums from Human Source
IIVIG1 “Human Immunoglobulin injection” 60 mg/ml; 50 ml/bot
適應症：IgG的替代治療用藥，適應症包括：1原發性免疫不全症（primary immune deficiency）。2骨髓瘤（myeloma）與慢性淋巴癌（chronic lymphatic leukamia）引致嚴重次發性免疫球蛋白缺乏（severe secondary hypogammaglobulinaemia）與復發性感染（recurrent infections）。3伴隨復發性感染之先天性免疫不全症（AIDS with recurrent infections）。用於改善免疫機能的治療，適應症包括：4原發性血小板缺乏性紫斑症【idiopathic thrombocytopenic purpura（ITP）】，有出血危險的成人或小孩ITP患者；或者，手術前用以修正血小板數目。5異體骨髓移植（allogeneic bone marrow transplantation）。6川崎氏症（Kawasaki Disease）。
Usual dose:
Primary immune deficiency disorder: 200 mg/kg IV once/mon; may increase to 300 mg/kg or repeat dose more frequently than once/mon for inadequate response.
B-cell chronic lymphocytic leukemia: 400 mg/kg IV q3-4 wks.
Bone marrow transplantation: 500 mg/kg IV beginning on day-7 and day-2 pretransplant (or at the time conditioning therapy for transplantation is begun), then weekly through day 90 posttransplant.
Idiopathic thrombocytopenic purpura: induction, 400 mg/kg IV on 2-5 consecutive days; may give an additional dose of 400 mg/kg IV if platelet count falls to < 30,000/mcL and/or p’t manifests clinically significant bleeding; for inadequate response, 800-1000 mg/kg IV as a single dose.
Kawasaki disease: 2 g/kg IV as a single dose beginning within 7 days of the onset of fever, administered concomitantly with aspirin (80-100 mg/kg/day in 4 divided doses; or 1 g/kg as a single IV dose or 400 mg/kg IV once daily for 4 days.
Adverse effect:
Common: flushing, injection site pain, nausea, anxiety, flushing, wheezing, abdominal cramps, myalgias, arthralgia, dizziness, fever, chills, headache, nausea, vomiting, chest tightness, changes in blood pressure or heart rate, dyspnea, leg cramps, headache.
Serious: Myocardial infarction, bullous dermatosis, erythema multiforme, Stevens-Johnson syndrome, hemolytic anemia, thrombotic disorder, hepatitis, anaphylaxis, aseptic meningitis, acute renal failure, hypokalemic nephropathy, renal proximal tubular disorder, acute tubular necrosis, acute respiratory distress syndrome, pulmonary edema.
健保使用規範：限符合下列適應症病患檢附病歷摘要（註明診斷，相關檢查報告及數據，體重、年齡、性別、病史、曾否使用同一藥品及其療效等）
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)