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Vol. 33, No. 12 101 年 12 15 異欄 Actemra Soln for IF tocilizumab 1. ( 8 2012/11/8 200 mg/10 ml /vial & 80 mg/4 ml /vial ACT1NB57 ACT1NB58 214 2. 療 Mirena intrauterine delivery system 52 mg/ius Trajenta F.C. 5 mg/tab Inspra F.C. 50 mg/tab levonorgestrel 1. 8 MIR9LF37 213 2. 不療 linagliptin 8 TRA4LB89 214 eplerenone 1. 8 INS4DA49 214 2. spironolactone 塞 LVEF40 % 療 2012/11/12 2012/11/22 2012/11/22 異欄 1 2012 年 10 3 異 4 Tocilizumab Actemra 樂 6 Levonorgestrel Mirena Intrauterine System 9 Linagliptin Trajenta 糖 10 見 Q & A 12 見易 13

() Nasonex Aqueous Nasal Spray mometasone furoate 1. 8 NAS3MA90 214 2012/11/22 50 mcg/dose, 2. Pulmicort Nasal Aqua 140 doses/btl 64 mcg/dose, 120 doses/btlbudesonide 8 PUL3MA81 療 Ufunin 2 mg/tab loperamide HCl 8 UFU4HB09 不 Imolex 2 mg/cap 8 IMO4HB09 11 量療 2012/11/20 Phenobarbital 30 mg/tab Premarin Vag Cream 0.625 mg/g, 42.5 g/tube Zyrtec Soln 1 mg/ml, 60 ml/btl Tienam (based on imipenem content) for Inj 500 mg/vial Polytar Emollient 350 ml/btl phenobarbital 8 PHE4JA05 不 Phenobarbital 30 mg/tab 8 PHH4JA05 11 量療 conjugated estrogens cetirizine 2HCl imipenem 500 mg, cilastatin 500 mg polytar emollient 8 PRE8LF13 不 Premarin Vag Cream 0.625 mg/g, 14 g/tube 8 PRE8LF56 11 量不療 8 ZYR5MD32 量不 Cetirizine Oral Soln 1 mg/ml, 60 ml/btl 8 CET5MD32 療復行 8 TIE1AK42 類 Mepem 500 mg/vialmeropenem trihydrate 復行 1. ( 8 POL6SD14) 蘭 Stiefel Lab 來更 Stiefel Lab 12 2. 量不療 2012/11/28 2012/11/29 2012/12/4 2012/12/4 2012/12/5

復 Ergonovine ergonovine 8 ERG4LG05 復 2012/11/16 0.2 mg/tab maleate 2012 年 11 Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events FDA dabigatran (Pradaxa) warfarin (CounadinJantoven ) 料來 FDA (Mini-Sentinel pilot of the Sentinel Initiative) 理行料 Pradaxa 率 warfarin 來 Pradaxa 臨 (RE-LY trial) FDA 來數 FDA 更 Pradaxa Pradaxa 療立 Pradaxa 量不更不療行 Pradaxa Pradaxa 行不良 Fungal Meningitis Outbreak Updated 兩 NECC - betamethasone FDA CDC NECC betamethasone 不 methylprednisolone acetate FDA NECC 療不 NECC 連參 FDA http://www.fda.gov/safety/medwatch/safetyinforma tion/safetyalertsforhumanmedicalproducts/ucm323 946.htm 2012/11/1 連參 FDA http://www.fda.gov/safety/medwatch/safetyinforma tion/safetyalertsforhumanmedicalproducts/ucm282 820.htm 2012/11/2

異 () 101 年 11 13 1010009409 9 Antineoplastics drugs 101 年 12 1 9.27. Cetuximab Erbitux(96/3/198/7/1 98/8/199/10/1101/12/1) 1. 療 (1) FOLFIRI (folinic acid/ 5-fluorouracil/ irinotecan) 療 (EGFR expressing)k-ras 療 (101/12/1) I. 療 12 惡 II. 療 24 III. 不 bevacizumab (2) irinotecan 療 5- fluorouracil (5-FU)irinotecan oxaliplatin 療 (EGFR) K-ras (98/8/1) I. 療 9 惡 II. 療 18 2. 咽咽療略 () 101 年 11 15 1010076100 8 Immunologic agents 101 年 12 1 8.2.11. Tocilizumab Actemra101/5/1 101/12/1 類療 1. (1) ( etanerceptadalimumab golimumab ) 療療類 I. Etanerceptadalimumab golimumab 療療 DAS28 降度 1.2 DAS28 3.2 II. etanercept adalimumab golimumab 療 (2) methotrexate methotrexate methotrexate 2. 3. (1) 療類量療 DAS28 料 (2) 療 I. tocilizumab 量 4 mg/kg 療 12 DAS28 療 ( 療 DAS28 降度 1.2 DAS28 3.2 ) 量 8 mg/kg 療 12 DAS28 降度 1.2 DAS28 3.2 101/12/1 II. 12 2 療 2 療錄 (3) 療 4. tocilizumab 療 - tocilizumab - 度 -New York Heart Association class IV - 女 - 療

- 不良 tocilizumab () 101 年 11 15 1010009630 8 Immunologic agents 101 年 12 1 8.2.4.1. Etanercept ( Enbrel)adalimumab ( Humira)(94/3/1101/12/1) 療 1. Etanercept 4 17 年 adalimumab 13 17 年 (101/12/1) 2. 3. (1) methrotexate corticosteroids 量療療 X 料 (2) etanercept adalimumab 六療 4. (1)(2)(3) (1) 列 Ι. (systemic) ΙΙ. (polyarticular)( 類 ) ΙΙΙ. 數 (extended oligoarticular) (2) 療 ( 列 ) Ι. methotrexate 療療 10 // methotrexate 療療 3 ( 若量降 ) ΙΙ. 若類來療類狀 prednisolone 量 0.25 (3) 3 : 列兩 Ι. 數 5 ΙΙ. 數 3 ( X ) 5. etanercept adalimumab 參狀 (1) 女 (2) 罹 (3) 罹罹 (4) 罹罹 (sepsis) (5) 惡 (pre-malignancy) (6) 不 (Immunodeficiency) 6. etanercept adalimumab 療列療 (1) 不良 Ι. 惡 ΙΙ. ΙΙΙ. (). (intercurrent infection)() 療不 core set data 6 療療療 Ι. 降率 (ESR) CRP 列 30% i. 數 ii. 數 iii. ΙΙ. 惡度 30% 不

六 etanercept () 六 adalimumab () () 101 年 11 15 1010076093 14 Ophthalmic preparations 101 年 12 1 14.1.(101/12/1) 14.1.1 (90/10/1101/12/1): 1. β- 神 (β-blockers) 2. (carbonic anhydrase inhibitor) : β-blockers 不不 3. 列類 (prostaglandin analogues)(93/2/1101/12/1) (1) β-blockers 不不 (2) 療不降 () 4. 2.5 ml() (101/12/1) 14.1.2 (92/2/1101/12/1) 1. 降療不良 ()(91/12/1 97/8/197/9/1101/12/1) 2. 2.5 ml() (101/12/1) 14.2. 略 14.3. 略 14.4. 略 14.5. 略 14.6. 14.7. Tocilizumab Actemra 樂狀 Actemra tocilizumab 類 -6(anti IL-6 receptor) IgG κh 2 L 2 C 6428 H 9976 N 1720 O 2018 S 42 214448 量 148 kda Actemra 不度 20 mg/ml 兩量 80 mg/4 ml200 mg/10 mlactemra disodium phosphate dodecahyrate sodium dihydrogen phosphate dehydrate ( 15 mmol/l )polysorbate 80 (0.5 mg/ml) 糖 50 mg/mlph 6.5 理 Tocilizumab 兩 IL-6 (sil-6r mil-6r) 行 IL-6 IL-6 T B 淋 IL-6 T 泌刺類滑泌 IL-6 更 IL-6 tocilizumab 力 Tocilizumab 類力 1793 tocilizumab 4 mg/kg8 mg/kg 類 (24) 力不度 - (AUC) 度 (C min ) 例量

度 (C max ) 例量度狀 AUC C min 8 mg/kg4 mg/kg2.76.5 Tocilizumab 4 mg/kg 8 mg/kg 量 AUC 13000±5800 35000±15500 (µg h/ml) C min (µg/ml) 1.49±2.13 9.74±10.5 C max (µg/ml) 88.3±41.4 183±85.6 AUC 1.11 1.22 (accumulation ratio) C max 1.02 1.06 C min 1.96 2.35 AUC 狀 C max C min 16 20 TocilizumabAUCC min C max 100 狀 AUCC min C max 55500±14100 µg h/ml19.0±12.0 µg/ml269±57 µg/ml 露量 tocilizumab 量不 800 mg Tocilizumab 兩行類 3.5 L 2.9 L 狀 6.4 L Tocilizumab 率率率度率力 12.5 ml/h tocilizumab 率度率率率度狀 4 mg/kg8 mg/kg11 13 methotrexate (MTX) 年度度類 (TNF antagonist) 療不若 MTX 不 MTX tocilizumab 不良見 (5 %) 咽 ALT/AST 暈 1. 不 tocilizumabtocilizumab 2. tocilizumab 療若療 tocilizumab 療療 3. 類 4. 數 (ANC)2000 /mm 3 100,000 /mm 3 AST/ALT 1.5 不 tocilizumab 5. 6. 7. tocilizumab 不 C 女行 tocilizumab 益力立力

tocilizumab 料 IL-6 降 cytochrome P-450 ( CYP1A2CYP2B6 CYP2C9CYP2C19CYP2D6 CYP3A4) mrna 降狀 tocilizumab 復 tocilizumab 療 cytochrome P-450 度 CYP2C8 P-gp tocilizumab 療若療量 cytochrome P-450 療 ( warfarin) 度 ( phenytoin) 行切 (CYP3A4 ) 不療若 tocilizumab 類行量類 MTX tocilizumab 量 4 mg/kg 臨 8 mg/kg 量不 800 mg 量 1. tocilizumab 療 2. 數異數 1-3 3-5 5 MTX 量若若降 tocilizumab4 mg/kg 數復數降 3 1-3 數 3 tocilizumab tocilizumab 3. 數 (ANC) 降數 (cells /mm 3 ) ANC1000 量 500ANC1000 ANC1000 cells/mm 3 4 mg/kg 復臨狀 8 mg/kg ANC500 tocilizumab 4. 數降數 (cells /mm 3 ) 50,000-100,000 數 100,000 cells /mm 3 4 mg/kg 復臨狀 8 mg/kg 50,000 tocilizumab 5. 老年 tocilizumab 度不 tocilizumab 量度度 tocilizumab 療行立 (B C ) 行療 Tocilizumab 0.9 % normal saline 100 ml 1 不 (bolus or push) tocilizumab polypropylene polyethylenepolyvinyl chloride polypropylenepolyethylene tocilizumab 2-8 C 24 Tocilizumab 不 tocilizumab 理行 Tocilizumab 不若 Tocilizumab2-8 C(36-48)

冷異若見不異參料 1..Product Information: ACTEMRA(R) solution for IV infusion, tocilizumab solution for IV infusion. Genentech, Inc, South San Francisco, CA, 2011. 2. Gerald K. McEvoy, Pharm.D., ed. 2012. AHFS Drug Information. Bethesda, MD. American Society of Health-System Pharmacists, Inc. ISBN 978-1-58528-247-0. ISSN 8756-6028. STAT!Ref Online Electronic Medical Library. http://online.statref.com/document.aspx?fxid=1& docid=1402. 8/9/2012 3. DRUGDEX System:Klasco RK (Ed): DRUGDEX System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com (cited: 08/09/2012). Levonorgestrel Mirena Intrauterine System 劉狀 Mirena T levonorgestrel levonorgestrel 52 mg 理 Mirenalevonorgestrel 來論精卵精卵精卵不易力 Mirena20 µg/24 hr 度 levonorgestrel 年降年度 14 µg/24 hrlevonorgestrel 度數 150~200 pg/ml 度 122460180±66 pg/ml 192±140 pg/ml159±59 pg/ml 1 療女療不良見不良良卵暈勞 1. Mirena 六狀數不律若不律 2. Mirena 若 6 3. Mirena 易狀更類 4. 若 Mirena Mirena 流 5. Mirena (pelvic inflammatory diseasespid) 20 6. 卵 7. Mirena 度來若不類來 8. Mirena 罹率 hormone-sensitive tumor 罹不類

9. Mirena 女女 6 10. 量 levonorgestrel 糖糖尿切糖 11. 留 12. Mirena 率 Mirena X 1 0.1 % levonorgestrel 泌女六行不 1. levonorgestrelsiliconepolyethylene 2. 3. 4. 復流易 5. 6. 異惡不不 7. 8. leukemia, AIDS, IV drug abuse Cytochrome P450 ( CYP 3A4) inducers 易 levonorgestrel 度降 (phenobarbitalphenytoincarbamazepine) (rifampicinrifabutin) (nevirapine efavirenz) Mirena 1. Mirena 行 2. 女立 4-12 年行 3. Mirena 年 Mirena 15 30 C 參料 1. DRUGDEX SYSTEM Klasco PK: DRUGDEX SYSTEM (electronic version). Thomson Micromedex, Greenwood Village, Colorado USA. Available at: http:/www.thomsonhc.com (cited: May/20/2012) 2. Physicians Desk Reference (electronic version). Thomson Micromedex, Greenwood Village, Colorado USA. Available at: http:/www.thomsonhc.com (cited: May/20/2012) 3. AFHS Drug Information Stat! Ref. Bethesda: American Society of Hospital Pharmacists,2012 4. The circular from the manufacturer of [Mirena] 5. Uptodate, Rose, BD (Ed), UpToDate, Waltham, MA, 2012. Available at: http://www.utdol.com/application/search.asp (May/20/2012). 6. The levonogestrel intrauterine system: long-term contraception and therapeutic effects. Women health(2005), 1(2), 171-182. 7. The efficacy, side-effects and continuation rates in women with symptomatic endometriosis undergoing treatment with an intra-uterine administered progestogen (levonorgestrel): a 3year follow-up. Farhana B. Lockhat, Joseph O. Emembolu, Justin C. Konje. Human Reproduction.Vol.20, No.3 p.789-793, 2005 Linagliptin Trajenta 糖林劉玲量

狀 Trajenta linagliptin 5 mg 理 Linagliptin dipeptidyl peptidase IV (DPP-4) incretins 糖尿糖 Incretins glucagon-like peptide-1 (GLP-1) glucosedependent insulinotropic polypeptide (GIP) 度 β glucagon 度 DPP-4 incretins 不 linagliptin DPP-4 incretins GLP-1 GIP 度降糖力 Linagliptin1.5 度率 30 % 1110 L 率 linagliptin 度不 75~99 % (90 %) linagliptin 不 5~7 % 尿 80 % ( ) 12 ( DPP-4) >100 糖尿 Linagliptin 不糖尿療糖尿 linagliptin 臨不良 linagliptin 糖率 7.6 % linagliptinmetforminsulfonylurea 22.9 % (6.4 %) (5.7 %) (5.7 %) 咽 (4.3-5.8 %) 尿 (2.7 %) (2.7 %) (2.4 %) (2.4 %) (2.3 %) (<1 %) US FDA Category B linagliptin ( 例 :) CYP3A4 inducers( 例 : rifampin phenytoinphenobarbitalcarbamazepine rifabutin) or P-gp inducer ( 例 : rifampinst John s Wort)linagliptin 度降療量 1. 量 5 mg 2. 18linagliptin 立 3. 不量 30 C 參料 1. Physicians' Desk Reference(electronic version),thomson Micromedex,Greenwood Village,Colorado,USA. Available at: http://www.thomsonhc.com (cited: 05/11/2012). 2. Drug Facts and Comparisons 56th ed. Missouri: Facts and Comparisons, 2012:509-511 3. Sweetman S (Ed), Martindale: The Complete Drug Reference. London: Pharmaceutical Press. Electronic version, Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com (cited: 05/07/2012) 4. Klasco RK (Ed): DRUGDEX System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com (cited: 05/07/2012). 5. The circular from the manufacturer of [ Trajenta]. 泌 ( 例 sulfonylurea) 降泌量降糖

見 Q & A 林 Q1 A1 冷裡老年狀 OOO 老年論來路療說 flavonoid glycosides 類理神年路不類臨來老年狀更來說更若都例靈流都見見流不不論行都 Q2 狀來 A2 狀來療狀不狀量狀不復狀律不度若了狀益不行

易 A 5 Coumadin 5 mg/tab (Warfarin Sodium) Dilatrend 25 mg/tab (Carvedilol) Dulcolax EC 5 mg/tab (Bisacodyl) Extraneal PD Solution Ultrabag 7.5% 2 L /bag (4984) (Peritoneal Dialysis Solution With Icodextrin) Filgrastim 75 mcg/0.3 ml /amp (Filgrastim) Heparin Sodium (with preservative) 25000 U/5 ml /vial (Heparin Sodium) Joulie Soln 500 ml /btl (Joulie Solution) Lactulose Liquid 600 mg/1 ml 500 ml /btl (Lactulose) Meptin 25 mcg/tab (Procaterol HCl) Pulmicort Turbuhaler 200 mcg/1 dose 100 doses /btl (Budesonide) B 1 Coumadin 1 mg/tab (Warfarin Sodium) 6.25 DILATREND 6.25 mg/tab (Carvedilol) Dulcolax Supp 10 mg/pill (Bisacodyl) Extraneal 7.5% 2 L /bag (4974) (Peritoneal Dialysis Solution with 7.5% Icodextrin) 300 Filgrastim 300 mcg/0.7 ml /amp (Filgrastim) Heparin Sodium (with preservative) 25000 U/5 ml /vial ( 不 ) (Heparin Sodium) Joulie Soln 200 ml /btl (Joulie Solution) Lactulose Liquid 600 mg/ml ( ml) (Lactulose) Meptin Liq 5 mcg/1 ml 60 ml /btl (Procaterol HCl) Pulmicort Respule 1 mg/2 ml /amp (Budesonide) Seretide 250 Accuhaler 60 doses /box (Salmeterol Xinafoate, 250 Seretide Evohaler 120 doses /box (Salmeterol Xinafoate, Fluticasone Fluticasone Propionate) Propionate) 40 Solu-Medrol 40 mg/vial (Methylprednisolone Sodium Succinate) 500 Solu-Medrol 500 mg/vial (Methylprednisolone Sodium Succinate) Solian 200 mg/tab (Amisulpride) Taita No.1 500 ml /btl (Dextrose and Electrolyte Solution) Taita No. 2 500 ml /btl (Dextrose and Electrolyte Solution) Taita No. 4 500 ml /btl (Dextrose and Electrolyte Solution) SOLAXIN 200 mg/tab (Chlorzoxazone) Taita No. 5 400 ml /btl (Dextrose and Electrolyte Solution) Taita No. 5 400 ml /btl (Dextrose and Electrolyte Solution) Taita No. 5 400 ml /btl (Dextrose and Electrolyte Solution) 20% Vitagen 20% 20 ml /amp (Dextrose) Vitagen 50% 20 ml /amp (Dextrose) 易 A 15 Abilify 15 mg/tab (Aripiprazole) 5 Abilify 5 mg/tab (Aripiprazole) ADALAT OROS 30 mg/tab (Nifedipine) Ateol 100 mg/tab (Atenolol) 1 Advagraf 1 mg/cap (Tacrolimus) 1 Prograf 1 mg/cap (Tacrolimus) Aldactone 25 mg/tab (Spironolactone) Aprovel FC 150 mg/tab (Irbesartan) Concor 5 mg/tab (Bisoprolol Hemifumarate) Crestor 10 mg/tab (Rosuvastatin (Calcium)) Diphenidol SC 25 mg/tab (Diphenidol HCl) B ( 尿 ) EURICON 50 mg/tab (Benzbromarone) Diovan FC 160 mg/tab (Valsartan) COZAAR 50 mg/tab (Losartan Potassium) Diovan FC 160 mg/tab (Valsartan) Predonine 5 mg/tab (Prednisolone) ( 4) Dupin 5 mg/tab (Diazepam) ( 4) Secorin 10 mg/tab (Oxazolam) ( 尿 ) EURICON 50 mg/tab (Benzbromarone) ( 4) Eurodin 2 mg/tab (Estazolam) Glibudon 500 mg/tab (Metformin HCl) Isoptin 40 mg/tab (Verapamil HCl) Lipofundin MCT/LCT 10% 250 ml /btl (Fat Emulsion) Lipanthyl Supra FC 160 mg/tab (Fenofibrate) 850 Glucophage 850 mg/tab (Metformin HCl) SR Isoptin SR 240 mg/tab (Verapamil HCl) Lipofundin MCT/LCT 10% 500 ml /btl (Fat Emulsion) Trenfylline SR FC 400 mg/tab (Pentoxifylline) ( 1) Morphine 10 mg/tab (Morphine HCl) ( 1) Morphine Sulfate SR 30 mg/tab (Morphine Sulfate) Nexium for inj 40 mg/vial (Esomeprazole) Pentasa SR 500 mg/tab (Mesalamine) Predonine 5 mg/tab (Prednisolone) Regrow SR 60 mg/tab (Dextromethorphan HBr) Nexium 40 mg/tab (Esomeprazole Magnesium) Protase EC/cap (Pancrelipase) Prometin 5 mg/tab (Metoclopramide HCl) Votan SR 100 mg/tab (Diclofenac Sodium) SOLAXIN 200 mg/tab (Chlorzoxazone) Strocain /tab (Oxethazaine, Polymigel) 25 Tofranil 25 mg/tab (Imipramine HCl) 10 Tofranil 10 mg/tab (Imipramine HCl) Zocor FC 40 mg/tab (Simvastatin) Zoloft 50 mg/tab (Sertraline HCl)