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1 藥品對應之適應症序號藥品名稱成份名劑型劑量適應症建議醫囑系統帶入之選項 1 5-HTP 2 Actonel 30 mg film-coated tablet L-5- hydroxytryptophan (5-HTP) Risedronate 3 Aldurazyme 2.9mg/5ml Laronidase (30 mg) 4 Alfalstin alpha 1-antitrypsin injection 5 Ammonul Injection 50mL 6 Buphenyl Tab. 500mg 7 Carnitine 1 g chewable tablets; Carnitene inj. 1gm; Levocarnitin Oral Solution 100 units/ml solution for infusion BH4 缺乏性苯酮尿症 ( 異型苯酮尿症 ) (Tetrahydrobiopterin (BH4) deficiency PKU 原發性變形性骨炎 (Primary Paget disease) 黏多醣儲積症第一型 BH4 缺乏性苯酮尿症 (Tetrahydrobiopterin (BH4) deficiency PKU 原發性變形性骨炎 (Primary Paget disease) 黏多醣儲積症第一型 (Mucopolysaccharidoses I ) 原發性 alpha 1-antitrypsin 缺原發性 alpha 1-antitrypsin 缺乏之乏之肺氣腫患者的替代治療肺氣腫患者的替代治療 Sodium phenylacetate and sodium benzoate injection 先天性尿素循環代謝障礙先天性尿素循環代謝障礙 Sodium Phenylbutyrate Levocarnitine 8 Ceredist taltirelin hydrate 9 Cerezyme Imiglucerase [Powder; Tablet] [3 gm /teaspoonful; 500 mg] (Injection; Oral Solution; Tablet)[ 200 mg/ml, 1 gm/10ml, 330 mg, 1gm] (200 units/vial) (400 units/vial) 缺乏 carbamylphosphate synthetase (CPS), Ornithine transcarbamylase (OTC) 或 Argininosuccinic synthetase (AS) 之先天性尿素循環障礙用於先天遺傳性代謝異常的續發性 Carnitine 缺乏症病患之急性慢性治療脊髓小腦變性症 spinocerebellar degeneration, SCD 第一型 (Type I) 高雪氏症 1.OTC 缺乏之先天性尿素循環障礙 (OTC deficiency,urea cycle disorder) 2.CPS 缺乏之先天性尿素循環障礙 (CPS deficiency,urea cycle 先天遺傳性代謝異常之續發性 Carnitine 缺乏症脊髓小腦變性症 (Spinocerebellar degeneration, SCD) 第一型 (Type I) 高雪氏症 (Type I Gaucher disease) (ICD-9:270.1) (ICD-9:731) (ICD-9:277.5) (ICD-9:277.6) (ICD-9:272.9) (ICD-9:334.3) 1.Aromatic L-amino acid decarboxylase deficiency(270.2) 2.Cerebral palsy(343.9) Mucopolysaccharidosis ( 未寫第幾型 ) 1.Propionic academia(270.3). 2.Citrullinemia(270.6) 3.Urea cycle defect 1. 氨基酸新陳代謝疾患 (270.9) 2.Lowe 氏症候群 (270.8) 3. 內分泌疾患 (259.9) 4. 脂質代謝疾患 (2729) 5. 併有腎病表徵之第二型 ( 非胰島素依賴型, 成人型 ) 或未明示型糖尿病, 未敘述為法控制 (25040) 1.Disorders of Lipoid metabolism (272.9) 2.LIPIDOSES(272.7) TFDA 公告刪除 taltirelin hydrate 為適用防治及藥物法之藥物新增 400units 10 Copaxone 20mg Solution for Injection Glatiramer acetate (20 mg/vial) (Multiple Sclerosis) 11 Cystadane powder fororal sol n 1gm/scoopful Betaine (Powder for Reconstitution) (1 gm/scoopful) 高胱氨酸尿症高胱氨酸尿症 (ICD-9:270.4) 1.Methylmalonic acidemia(270.3) 2. 先天維他命 B12 代謝異常 3. 含硫氨基酸代謝障礙 (270.4) 12 Cystagon Cap. 150mg Cysteamine Bitartrate (EQ 50 mg, 150 mg Base) nephropathic cystinosis 腎胱胺酸病 (nephropathic cystinosis) (ICD-9:270.0)

2 13 Elaprase solutionfor intravenous infusion 2mg/ml 6mg/vial Idursulfase (iduronate-2- sulfatase) (2mg/ml 6mg/vial) long term enzyme replacement therapy for patients with MPS II (Hunter Syndrome) 1. 第 II 型黏多醣症 (Mucopolysaccharidosis II) 2. 亨特氏症候群 (Hunter Syndrome) (ICD-9:277.5) Mucopolysaccharidosis ( 未寫第幾型 ) 14 Fabrazyme 35mg Inj. Agalsidase-beta alpha-galactosidase A deficiency (Fabry disease) 1.alpha-galactosidase A deficiency 2. 法布瑞氏症 (Fabry disease) 1.Lipidoses(272.7) 2. 脂肪代謝障礙 (272.7) 3.ICD-9: Flolan Inj. Epoprostenol (0.5 mg base/vial; 1.5 mg base/vial) 16 Imukin Inj. Interferon-Gamma 1b 慢性肉芽腫病 (Chronic 慢性肉芽腫病 (100 mcg/0.5ml) Granulomatous Disease) (Chronic Granulomatous Disease) Recombinant human 萊倫氏症候群 17 Increlex 10mg/ml 5ml insulin-like growth Laron Syndrome (Laron Syndrome) factor 1 rhigf-1 18 INOmax Nitric Oxide (Inhaler) 新生兒用新生兒用 19 Kelfer Capsules 250 mg, 500 mg 20 K-PHOS NO.2 21 L-Arginine HCl Inj.30ml/vial Deferiprone (Kelfer) potassium acid phosphate + sodium acid phosphate, anhydrous Arginine (250 mg;500 mg) (10 gm/100ml) 重型海洋性貧血 (Thalassemia major) 病人, 使用 Deferrioxamine 治療不理想或重型海洋性貧血法接受時 ; 或在醫師嚴格 (Thalassemia major) 監測不良反應 ( 如 : 白血球數目, 肝功能狀況 ) 下, 與 Deferrioxamine 合併使用性聯遺傳型低磷酸鹽性佝僂性聯遺傳型低磷酸鹽性佝僂症症 [X-linked hypophospatemic (X-linked hypophospatemic Rickets] Rickets) 尿素循環障礙尿素循環障礙 22 Myozyme 50mg inj. alpha-glucosidase injection 龐貝氏症龐貝氏症 (Pompe disease) 23 Naglazyme Inj. 5mg/5ml/vial Galsulfase 24 Neurontin Gabapentin 25 Nitoman Tablet 25mg, Xenazine tetrabenazine (5.0 mg/vial) (Capsule; Tablet) (600 mg, 800 mg) 黏多醣症第 6 型 Mucopolysaccharidosis VI 脊髓側索硬化症 (Amyotrophic Laterol Sclerosis ALS) 亨汀頓氏舞蹈症 Huntington disease 26 Normosang inj. Hemin 紫質症紫質症 27 Orfadin Nitisinone 2.0 mg/cap 酪胺酸血症第一型 Tyrosinemia type I 黏多醣症第 6 型 (Mucopolysaccharidosis VI) 脊髓側索硬化症 (Amyotrophic Laterol Sclerosis)(ALS) 亨汀頓氏舞蹈症 (Huntington disease) 酪胺酸血症第一型 (Tyrosinemia type I) (ICD-9:288.1) (ICD-9:259.4) (ICD-9:282.4) (ICD-9:275.3) (ICD-9:271) ((ICD-9:277.5) (ICD-9:335.20) (ICD-9:333.4) ((ICD-9:277.1) (ICD-9:270.2) Functional disorders of polymorphonuclear neutrophils 童年期缺乏正常預期之生理發展 (783.4) 1. 急性扁桃腺炎 (463) 2.DISORDERS OF IRON METABOLISM(275) 3.APLASTIC ANEMIA(284.9) 4.APLASTIC ANEMIA(284) 1. 鈣代謝疾病 (275.4) 2. 磷代謝疾病 (275.3) 1. 肝醣貯積症 (271.0) 2.Mucopolysaccharidoses 3.GLYCOGENOSIS Mucopolysaccharidosis ( 未寫第幾型 ) 1. 結節性硬化症 (759.5) 2. 遺傳性末梢神經病變 3. 神經痛神經炎及神經根炎

3 28 Phosphate solution Phosphate solution (Solution) 性聯遺傳型低磷酸鹽性佝僂性聯遺傳型低磷酸鹽性佝僂症症 [X-linked hypophospatemic (X-linked hypophospatemic Rickets] Rickets) (ICD-9:275.3) 29 Proglycem 50mg/ml, 30ml/bot. Diazoxide (Capsule, Suspension) (50 mg; 50 mg/ml) persistent hyperinsulinemic hypoglycemia of infancy (PHHI) 永久性血胰島素過高性嬰兒低血糖症 (persistent hyperinsulinemic hypoglycemia of infancy) (PHHI) (ICD-9:251.1) 1. 高胰島素引起之低血糖及其他相關症狀 (251.1) 2.Liver tumor, pancreas metastatic(239.0) 3.NIPHS 30 Protein C-LFB protein C injection 先天性 protein C 缺乏所致之嚴重靜脈血栓先天性 protein C 缺乏所致之嚴重靜脈血栓 (ICD-9:273.3) 31 Rebif inj. 22 mcg, 44 mcg Interferon-Beta-1a 32 Remodulin Inj.1.0mg/ml 20ml treprostinil sodium 33 Replagal 3.5mg Inj. Agalsidase-alpha ( 3MIU 6MIU 12MIU/vial) (1.0, 2.5, 5.0, 10.0 mg/ml) (Multiple Sclerosis) alpha-galactosidase A deficiency (Fabry disease) 1.alpha-galactosidase A deficiency 2. 法布瑞氏症 (Fabry disease) 1. 下身麻痺截癱 2.ICD-9: Revatio 20mg Film-Coated Tablets Sodium Benzoate Cap.250mg 36 Stimol oral Solution 1g/10ml Citrulline 37 Sucraid Oral Solution Sacrosidase 38 Tetrahydro-Biopterin(BH4) 10mg Cap., 50mg Sildenafil citrate (20 mg) Sod. Benzoate [250 mg] Non-ketotic hyperglycinemia Tetrahydro- Biopterin(BH4) (Tablet, 600 mg) (oral solution, 1 g/10 ml) (Oral Solution) (900 IU/ml) (10, 50 and 100 mg) 先天性因 citrulline 缺乏引起尿素代謝異常之高血氨症 PKU with congenital sucraseisomaltase deficiency Treatment of patients with hyperphenylalaninemia due to tetrahydrobiopterin deficiency. Tetrahydrobiopterin-responsive phenylketonuria(pku). 先天性非酮性高甘氨酸血症 (Non-ketotic hyperglycinemia) 1. 先天性因 citrulline 缺乏引起尿素代謝異常之高血氨症 2.Urea cycle disorder PKU with congenital sucraseisomaltase deficiency 1. 四氫基喋呤缺乏引起的高苯胺酸血症 (Treatment of patients with hyperphenylalaninemia due to tetrahydrobiopterin deficiency. ) 2. 四氫基喋呤 - 反應型苯酮尿症 (Tetrahydrobiopterin-responsive phenylketonuria(pku).) (ICD-9:270.7) (ICD-9: ) (ICD-9:270.1) 1. 慢性阻塞性肺病 (496) 2. 原性纖維性肺泡炎 (516.3) 3. 續發性肺動脈高血壓 (710.3) 4.Raynaud's syndrome(443) 1.Hyperglycinemia(270.7) 2. 直鏈氨基酸代謝之其他障礙 3. 瓜胺酸血症 1.Phenylketonuria( PKU ) (270.1) 2.Hyperammonemia(270.6) 3.OTC deficiency(270.6) 39 Tobi Nebulizer Solution Tobramycin 300 mg/5 ml solution for inhalation 囊狀纖維化症患者因基因缺囊狀纖維化症患者因基因缺陷陷致肺部因綠膿桿菌慢性感致肺部因綠膿桿菌慢性感染, 造染, 造成反覆急性發作支氣成反覆急性發作支氣管擴張症管擴張症之持續性治療之持續性治療 (ICD-9:277) 囊狀纖維化症 (277) 40 TPN for PKU with congenital sucrase-somaltase deficiency 之全靜脈營養注射 TPN For PKU with congenital sucrase-isomaltase deficiency 之全靜脈營養注射劑 TPN For PKU with congenital sucrase-isomaltase deficiency 之全靜脈營養注射劑 (ICD-9: )

4 41 42 Tracleer 125mg film-coated tablets, 62.5mg Trientine dihydrochloride 300mg/Cap. ; Syprine (Trientine HCl 250mg/Cap.) 43 Tysabri Natalizumab Bosentan 62.5 and 125 mg tablet 原發性肺動脈高血壓 Trientine HCl [Capsule] [250, 300 mg] 威爾森氏病 (Wilson Disease) 300 mg/15 ml vial, solution for infusion 原發性肺動脈高血壓威爾森氏病 (Wilson Disease) (ICD-9:275.1) 1.Pulmonary hypertension(416.8) 2.ICD-9: Other chronic pulmonary heart diseases(416.8) 銅代謝疾患 (275.1) 44 Ventavis Nebuliser Solution 20mcg Iloprost nebuliser solution solution for infusion 45 Zadaxin Inj. Thymosin alfa 1 injection DiGeorge Syndrome DiGeorge Syndrome (ICD-9:279.11) 1.Liver cirrhosis(571) 2.Pul.HT.Idiopath.(416) 46 Zavesca Capsules 100mg Miglustat capsule Type I Gaucher Disease Niemann-Pick Disease Type C 1. 第一型 (Type I) 高雪氏症 (Type I Gaucher disease) 2.C 型尼曼匹克氏症 (Niemann-Pick Disease Type C) Lipidoses(272.7) 47 Zinca Capsules 50mg, 25mg; Wilizin Capsules 25mg, 50mg Zinc Acetate [Capsule] [25-50 mg] 威爾森氏病 (Wilson Disease) 威爾森氏病 (Wilson Disease) (ICD-9:275.1) 1. 銅代謝疾患 (275.1) 2.Liver Disease ( 肝硬化肝臟移植併發症 ) 符合罕病法第 22 條困難取得定義 48 Agrylin 0.5 mg capsule Anagrelide 49 Antivenin of D.russellii (Lyophilized) Antivenin of Vipera Russelli 50 Asadin Inj. 1mg/ml 10ml Arsenic Trioxide (0.5 mg; 1.0 mg) 原發性血小板過多症原發性血小板過多症 (Essential thrombocythemia) ICD-9: 鎖鏈蛇咬傷鎖鏈蛇咬傷 ICD-9:989.5 (1 mg/ml, 10ml/vial) (Acute promyelocytic leukemia)(apl) ICD-9: BAL Dimercaprol (10%) 重金屬解毒劑重金屬解毒劑 52 Dantrolene 20mg IV Dantrolene (20 mg/vial) 惡性高溫熱惡性高溫熱 (malignant hyperthermia) ICD-9: Dilantin 30mg Cap. Phenytoin (30 mg) 癲癇症 ( 限用於調整劑量 ) 癲癇症 ( 限用於調整劑量 ) 1. 原發性血小板過多症 ( ) 2. 原發性血小板過多症 (238.7) 3. 其他淋巴及造血組織之臨床表現未明腫瘤 (238.7) 4. 慢性紅血病 (207.1) 5. 家族性紅血球過多症 (289.6) 6. 血液與造血器官疾病 (2899) 1. 急性骨髓細胞白血病 (Acute myeloid leukemia) (AML) 2. 皮膚癌 (173.7) 3. 骨隨性白血病未提及緩解 (205.9) 1.fever(780.6) 2.Neuroloptic malignant syndrome(333.92) 54 Dimaval Capsules (RS)-2,3-Dimercapto- 1-propanesulfonic acid (DMPS), sodium salt, Monohydrate 1. 急性汞中毒急慢性汞中毒 ( 金屬汞, 揮 2. 慢性汞中毒發性有機或機化合物 ) 慢 3. 揮發性有機或機化合物中毒性鉛中毒 4. 慢性鉛中毒

5 55 Dimaval Injection Solution 56 Dimersu Capsules 200 mg (RS)-2,3-bis (sulphanyl) propane- [Meso-2,3- dimercaptosuccinic acid, DMSA] 急性汞中毒解毒劑急性汞中毒解毒劑 (100 mg) 鉛砷汞中毒之解毒 1. 鉛中毒之解毒 2. 砷中毒之解毒 3. 汞中毒之解毒 57 Lysodren Tab. Mitotane (500 mg) 腎上腺皮質癌腎上腺皮質癌 ICD-9:194 1.Ag( 銀 ) 中毒解毒劑 (989.9) 2.ICD-9: ICD-9: 腎上腺腫瘤及其他相關症狀 (162.9) 2.Malignant neoplasm of adrenal gland(239.7) 58 Provigil tablet 200 mg Modafinil 200 mg 改善猝睡症患者的日間過度睡眠症狀猝睡症 ICD-9: 其他睡眠障礙 (780.59) 2. 重鬱症, 復發, 輕度 (296.31) 3.Nonorganic sleep disorder, unspecified(30740) 4.Sleep disorders(30741) 59 THADO Capssules 50 mg Thalidomide (50 mg) 結節狀紅斑 leprosum 結節狀紅斑 leprosum ICD-9: 肝腫瘤 (155) 2. 多發性骨髓瘤 (203) 60 Thyrogen 1.1 mg/vial Thyrotropin alfa Injection [Injection] [1.1mg/ml] 甲狀腺分化癌治療之輔助診斷製劑甲狀腺分化癌治療之輔助診斷製劑甲狀腺惡性腫瘤 (193) 61 Vesanoid Soft Gelatin Capsules 10mg Tretinoin soft gelatin capsules 10 mg (Acute promyelocytic leukemia)(apl) ICD-9: 急性骨髓細胞白血病 (Acute myeloid leukemia) (AML) 2. 未明示之白血球疾病 3. Acute granulocytic leukemia (AGL)(205.00) 62 VSL#3 450 billionbacteria/packet Lactic acid bacteria oral use chronic pouchitis disease 慢性囊炎疾病慢性囊炎疾病 (chronic pouchitis disease) CDC 有防疫需求, 且符合罕病法第 22 條困難取得定義 63 Albenza; Zentel Albendazole (200 mg) 鉤蟲感染之表皮幼蟲移行症鉤蟲感染之表皮幼蟲移行症 64 Humatin Paromomycin Sulfate (250 mg) 65 Malarone F.C. Tablet Atovaquone-proguanil (250 mg+100 mg) 隱孢子蟲感染阿米巴性痢疾隱孢子蟲感染阿米巴性痢疾瘧疾瘧疾 Need for other prophylactic vaccination and inoculation against other specified disease 66 Mephaquin Mefloquine (250 mg) 瘧疾瘧疾 (100 mg/ml, 67 Pentostam Inj. Sodium Stibogluconat 100 ml/bot) 利什曼症 ( 黑熱病 ) 利什曼症 ( 黑熱病 ) 68 Primacin (7.5 mg) 瘧疾肺囊蟲肺炎瘧疾肺囊蟲肺炎 69 Pyrimethamine Pyrimethamine (25 mg) 弓形蟲感染弓形蟲感染 70 Stromectol Ivermectin (3 and 6 mg) 糞小桿線蟲感染血絲蟲感染糞小桿線蟲感染血絲蟲感染

6 71 Yodoxin Iodoquinol (210mg; 650 mg) 阿米巴性痢疾阿米巴性痢疾 72 Artemisinin Artemisinin (100 mg) 瘧疾瘧疾 73 Diloxanide Furoate Diloxanide Furoate (500 mg) 痢疾阿米巴帶原者痢疾阿米巴帶原者新增適用罕見疾病防治及藥物法之藥物品項 74 Methylene blue injection 1% 75 Dalfampridine 76 Fingolimod 77 Antisense inhibitor of apolipoprotein B Everolimus [SR tablet] [10 mg] [hard capsule] [0.5 mg] [injection][200 mg] [tablet] [2.5 mg; 5 mg] 變性血紅素血症 (Methemoglobinemia) (Multiple Sclerosis) 復發型 ( 前一年有一次復發或前兩年有兩次復發者 ) 同合子家族性高膽固醇血症結節性硬化症具有明確成長跡象或腫瘤已引起水腦現象之腦室管膜下巨細胞星狀瘤 (TSC-SEGA) 說明 : 明確成長跡象為 : 腫瘤比原先病灶長大 25% 以上, 或是有最大直徑 1 公分以上之新病灶 78 Apo-Mefloquine Apo-Mefloquine 250mg tablets 瘧疾瘧疾變性血紅素血症 (Methemoglobinemia) 復發型 (ICD-9:272.0) 不建議為第一線用藥病人須經基因檢測確診為同合子家族性高膽固醇血症才可使用本藥品

健保用藥且適用「罕見疾病防治及藥物法《之品項檔( 更新)

健保用藥且適用「罕見疾病防治及藥物法《之品項檔( 更新) V000003221 V000002100 Dimaval Inj. Solution Dimaval Capsules (RS)- 2,3Bis(Sulphanyl)Propan e-1-sulphonic acid, Sodium salt- (monohydrate) 50mg Sodium-2,3-Dimercapto- 1-Propane Sulfonate (Monohydrate) 100mg