1.8.2 Page MIC () MIC 50 / MIC 90 µg/ml Candida albicans (54) / Candida glabrata (25) 0.25 / 0.5 Candida guilliermondii a) (2)
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- こうざぶろう ことじ
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1 1.8.2 Page % B (1) in vitro 1) in vitro C. glabrata C. krusei MIC MIC 2
2 1.8.2 Page MIC () MIC 50 / MIC 90 µg/ml Candida albicans (54) / Candida glabrata (25) 0.25 / 0.5 Candida guilliermondii a) (2) Candida krusei a) (5) Candida parapsilosis (13) / Candida tropicalis (12) / Aspergillus fumigatus (10) 0.25 / 0.5 Other Aspergillus spp. a) (8) Cryptococcus neoformans (16) / 0.25 Fusarium oxysporum a) (2) 4 >8 Fusarium solani a) (1) 2 Scedosporium apiospermum a) (4) a) 10 MIC 99M109,496MIC1 Table12 23 MIC MICµg/mL A. fumigatus A. niger C. albicans C. glabrata C. guilliermondii C. krusei C. parapsilosis C. neoformans Fusarium sp A Table µg/ml SD=1.8 µg/ml 2.9 µg/ml 0.6 µg/ml8.4 µg/ml MIC
3 1.8.2 Page3 2) PK 4.6 L/kg ng/ml 1000 ng/g 3) ( ) 1/2 5/5 4/4 1/1 11/12 (91.7%) 10/16 3/5 14/18 1/1 28/40 (70.0%) () / 3 3 (150307/602) (150309/604) 11/21 23/38 1/2 1/1 36/62 (58.1%) 67/119 1/2 2/7 1/1 71/129 (55.0%) 40/86 4/12 5/9 4/7 53/114 (46.5%) 3 (150608) 162/ /248 (65.3%)
4 1.8.2 Page4 3 ( ) 1/1 7/7 8/8 (100%) () / 3 3 (150307/602) (150309/604) 1/4 0/1 3/9 1/2 1/1 6/17 (35.3%) 1/2 1/1 2/4 0/1 4/8 (50.0%) 0/3 1/2 2/2 0/1 0/1 3/9 (33.3%) 47/60 (78.3%) 71/129 (55.0%) 102/210 (48.6%) 3 (150608) 162/248 (65.3%) (a) 1/2 5/5 4/4 1/1 11/1291.7% 28/4070.0% 8/8100% in vitro MIC= µg/ml 3/933.3% 1 3 MIC 4 µg/ml
5 1.8.2 Page5 MIC 4/850.0% in vitro 4) (a) In vitro DI/022/0Scedosporium apiospermum B MIC µg/ml Scedosporium apiospermum 4 MIC µg/ml (b) In vivo in vivo DI/09/98 DI/002/98 2 Scedosporium apiospermum a) DI/09/98 S. apiospermum H mg/kg mg/kg CTD (1) 1) DI/022/0 2CTD (2) 4) Scedosporium p3233
6 1.8.2 Page6 4 S. apiospermum H76.03 (mg/kg) log 10 CFU/g ± /11 <0.08 *** 0.65 ± 0.27 *** 1.44 ± 0.19 *** 0.33 ± 0.26 *** 2.62 ± 0.29 *** 5 11/11 <0.08 *** 0.92 ± 0.43 ** 1.58 ± 0.34 *** 0.50 ± 0.39 *** 2.88 ± 0.44 *** 2.5 3/11 <0.07 *** 1.71 ± ± ± 0.49 ** 3.64 ± 0.52 *** 10 1/ ± 0.78 *** 1.63 ± 0.52 * 2.83 ± ± 0.36 * 4.22 ± 0.46 *** 0 0/ ± ± ± ± ± 0.44 * = P<0.05, ** = P<0.01, *** = P<0.001 t DI/09/98Table 2 b) DI/002/98 S. apiospermum H mg/kg mg/kg B 2.5 mg/kg S. apiospermum H76.03 (mg/kg) log 10 CFU/g B /11 <0.08 *** <0.63 * 2.20 ± 0.81 ** <0.84 ** 3.16 ± 0.70 ** 5 9/ ± 0.39 ** 0.76 ± 0.56 * 2.42 ± 0.68 * 0.95 ± 0.55 ** 3.36 ± 0.69 ** 1 7/ ± ± ± ± ± /11 <2.66 < ± ± ± / ± ± ± ± ± / ± ± 0.30 * 2.43 ± ± ± /10 < ± ± ± 0.74 * 4.62 ± / ± ± ± ± ± 0.56 * = P<0.05, ** = P<0.01, *** = P<0.001 t DI/002/98Table 3
7 1.8.2 Page7 (c) / /604 (MITT) ID MIC(µg/mL) S. apiospermum S. apiospermum ALL S. prolificans ALL S. prolificans AML Scedosporium sp. N/A S. apiospermum S. apiospermum 0.25 a) S. apiospermum N/A AML S. apiospermum CML Pseudallescheria boydii b) CTD p69 35 a) b) S. apiospermum / /604 1/24/12 1 A / /211/21 23/31 2 a) 2 1CTD (1) 3) 2CTD (1) 3)
8 1.8.2 Page8 Thomas J. Walsh et al, Pediatric Infectious Disease Journal 2002; 21: CNS %3/5 Mark A. Nesky et al, Clinical Infectious Disease 2000; 31: Pseudallescheria boydiiscedosporium apiospermum 1 59 CT B MRI Pseudallescheria boydii MIC B MIC > µg/ml b) 4 Thomas J. Walsh et al, Pediatric Infectious Disease Journal 2002; 21: Corrado Girmenia et al, Journal of Clinical Microbiology 1998; 36: Scedosporium apiospermum CT Scedosporium apiospermum B 7
9 1.8.2 Page9 Scedosporium apiospermum B MIC µg/ml Patricia Munoz et al, Clinical infectious Disease 2000; 31: CT Scedosporium apiospermum 7 CT Scedosporium apiospermum MIC µg/ml B.P Howden et al, European Journal of Clinical Microbiology and Infectious Disease 2003; 22: nonmyeloablative BMT 53 MRI 3 Scedosporium prolificans Scedosporium prolificans 15 MRI Scedosporium prolificans MIC 24>16 µg/ml MIC µg/ml 0.5 µg/ml
10 1.8.2 Page10 (d) 5) EU
11 1.8.2 Page
12 1.8.2 Page12 (2) 40 kg mg mg mg mg mg kg mg mg mg mg/kg mg/kg 1 4 mg/kg kg
13 1.8.2 Page13 1) 2 (a) 3 A a) 3 c) mg bid a) 300 mg bid 200 mg bid 200 mg bid 150 mg bid 4 mg/kg bid 4 mg/kg bid 4 mg/kg bid b) 6 mg/kg bid 3 mg/kg bid 3 mg/kg bid 3 mg/kg bid 3 mg/kg bid 2.5 µg/ml 2.5 µg/ml 2.5 µg/ml 2.5 µg/ml bid1 2 a) 40 kg mg mg 1 2 b) µg/ml 200 mg µg/ml 150 mg 1 2 c) mg mg/kg mg mg mg kg 4 mg/kg mg/kg µg/ml mg mg/kg 1 2 MIC 1 µg/ml 6 µg/ml 4.5 µg/ml µg/ml PK
14 1.8.2 Page14 CYP2C19 1 µg/ml 6 µg/ml mg kg 150 mg mg/kg CYP2C19 1 µg/ml 6 µg/ml µg/ml 12 b) 3 40 kg 40 kg CYP2C CYP2C19 DRC DRC kg 40 kg mg mg/kg 1 2 EM HEM PM
15 1.8.2 Page kg N= a) CYP2C19 EM HEM PM EM HEM PM 300 mg mg mg mg mg mg/kg mg/kg mg/kg mg/kg (1)Table 5.1 a) kg 1 (N=81) EM HEM PM 28 a) 1.6 mg/kg 4.0 mg/kg 3.0 mg/kg 3.0 mg/kg 2.6 mg/kg 3.0 mg/kg 3.0 mg/kg 66 a) 57.7 mg mg mg mg mg mg mg (1)Table 5.2 a) kg 40 kg mg mg/kg kg N= a) CYP2C19 EM HEM PM EM HEM PM 200 mg mg mg mg mg/kg mg/kg (1)Table 5.1 a)
16 1.8.2 Page kg 1 (N=11) EM HEM PM 4 a) 2.1 mg/kg 4.0 mg/kg 3.0 mg/kg 3.0 mg/kg 3.0 mg/kg 11 a) 50 mg mg mg mg mg mg mg (1)Table 5.2 a) mg kg 100 mg mg/kg mg mg/kg CYP2C19 EM3 HEM13 PM1 1 EM2 HEM2 57 EM HEM PM mg mg/kg EM2 HEM2 1 7 EM2 HEM3 PM kg 150 mg EM1 HEM mg mg mg/kg 1 2 CYP2C µg/ml 1 PM µg/ml µg/ml PM 200 mg mg/kg CYP2C19 PM 200 mg mg mg/kg mg/kg 1 2 EM HEM 2.5 µg/ml 200 mg mg1 2 4 mg/kg mg/kg 1 2 CYP2C µg/ml 150 mg 1 2 3
17 1.8.2 Page17 mg/kg µg/ml CYP2C Plasma µ concentration of voriconazole (ug/ml) EM HEM PM 1 CYP2C %50%75% 25% 75% µg/ml (SD=1.8 µg/ml) 2.9 µg/ml 0.6 µg/ml8.4 µg/ml c) 3 DRC PPS %50/ %11/ %28/41 100%8/8 PPS PPS mg 1 2 DRC 4 CYP2C19 HEM CYP2C19
18 1.8.2 Page18 11 PPS a) 1 (%) EM HEM PM 250 mg 0/0 0/0 0/0 1/1 1/1 200 mg 3/3 10/10(100%) 1/1 1/1 15/15(100%) 150 mg 7/8(87.5%) 4/4 6/7(85.7%) 0/2 17/21(81.0%) 100 mg 1/2 3/4 0/0 0/1 4/7(57.1%) 50 mg 0/0 0/1 0/0 0/0 0/1 4.0 mg/kg 0/0 1/1 0/0 0/0 1/1 3.5 mg/kg 0/0 1/1 0/0 0/0 1/1 3 mg/kg 2/4 4/6(66.7%) 1/1 2/3 9/14(64.3%) 2 mg/kg 0/0 1/1 0/1 0/1 1/3 13/17(76.5%) 24/28(85.7%) 8/10(80.0%) 4/9(44.4%) 49/64(76.6%) (1)Table 4.7 a ) 1 d) % % CYP2C19 PM EM/HEM 3 3 CYP2C AST, ALT, AlP, GTP, 2.7.3
19 1.8.2 Page19 12 (%) 1 EM HEM PM 300 mg 1/1(100%) /1(100%) 250 mg /1(100%) 1/1(100%) 200 mg 3/3(100%) 12/13(92.3%) 1/1(100%) 1/1(100%) 17/18(94.4%) 150 mg 10/12(83.3%) 6/6(100%) 7/8(87.5%) 5/5(100%) 28/31(90.3%) 100 mg a) 2/2(100%) 4/5(80.0%) 1/1(100%) 1/1(100%) 8/9(88.9%) 50 mg b) 0 1/1(100%) 0 0 1/1(100%) 4 mg/kg 2/2(100%) 2/2(100%) 0 0 4/4(100%) 3.5 mg/kg 0 1/1(100%) 0 0 1/1(100%) 3 mg/kg 6/6(100%) 8/8(100%) 4/4(100%) 5/5(100%) 23/23(100%) 2 mg/kg 0 1/1(100%) 1/1(100%) 1/1(100%) 3/3(100%) 24/26(92.3%) 35/37(94.6%) 14/15(93.3%) 14/14(100%) 87/92(94.6%) (1)Table 6.1 a) 40 kg 5 40 kg 4 b) 40 kg 13 (%) 1 EM HEM PM 300 mg 1/1(100%) /1(100%) 250 mg /1(0%) 0/1(0%) 200 mg 2/3(66.7%) 6/13(46.2%) 1/1(100%) 1/1(100%) 10/18(55.6%) 150 mg 5/12(41.7%) 4/6(66.7%) 6/8(75.0%) 4/5(80.0%) 19/31(61.3%) 100 mg a) 1/2(50.0%) 3/5(60.0%) 1/1(100%) 1/1(100%) 6/9(66.7%) 50 mg b) 0 0/1(0%) 0 0 0/1(0%) 4 mg/kg 0/2(0%) 1/2(50.0%) 0 0 1/4(25.0%) 3.5 mg/kg 0 1/1(100%) 0 0 1/1(100%) 3 mg/kg 3/6(50.0%) 5/8(62.5%) 3/4(75.0%) 3/5(60.0%) 14/23(60.9%) 2 mg/kg 0 0/1(0%) 1/1(100%) 1/1(100%) 2/3(66.7%) 12/26(46.2%) 20/37(54.1%) 12/15(80.0%) 10/14(71.4%) 54/92(58.7%) (1)Table 6.2 a) 40 kg 5 40 kg 4 b) 40 kg
20 1.8.2 Page20 ID 14 (kg) HEM PM HEM a mg b) c) d) e) 1 a) b) c) d) 1 e) e) mg 200 mg kg 100 mg mg/kg 4 mg/kg mg kg 100 mg mg/kg PM HEM/EM CYP2C19 PM EM/HEM (b) 1 1 A mg 1
21 1.8.2 Page mg 1 2 CYP2C mg 1 2 CYP2C19 HEM/EM mg mg/kg 1 2 CYP2C19 4 mg/kg 1 2 CYP2C19 HEM/EM 1 3 mg/kg4 mg/kg 1 2 (c) CYP2C19 CYP2C19 CYP2C19 3 PK CYP2C CYP2C CYP2C EMHEM 2.5 µg/ml 1 µg/ml 6 µg/ml 1PM PM CYP2C19 EM HEM PM (d) mg mg kg 100 mg mg/kg 1 4 mg/kg 1 2
22 1.8.2 Page mg mg/kg 1 2 5) 2) 1 A mg mg (ng/ml) 2 A VRCJP mg/kg mg/kg 4 mg/kg
23 1.8.2 Page23 (ng/ml) 3 VRCJP A mg mg/kg mg mg mg/kg ) PK 96%CV 13% 3 PK 100% ph
24 1.8.2 Page24 4) 40 kg kg mg µg/ml 40 kg 40 kg 40 kg PK 3 40 kg 40 kg 40 kg 150 mg mg µg/ml 25%75% 40 kg kg (1)Table kg 40 kg kg 76.8%43/56 40 kg 77.8%7/ kg 80.2%69/86 40 kg 64.3%9/14 40 kg 150 mg mg 1 2
25 1.8.2 Page25 5) Therapeutic Drug Monitoring (TDM) µg/ml PK/PD 2/3 TDM (a) a) A AST, ALT,GTP 3 HEM1 300 mg 1 2 VRCJP96503 AST,ALT,GTP 2 PM 1 HEM mg µg/ml 4.5 µg/ml 4.5 µg/ml 1
26 1.8.2 Page26 血漿中ボリコナゾール濃度のトラフ値 (μg/ml) EM / HEM 200 mg bid (A ) EM / HEM 300 mg bid (A ) PM 200 mg bid (A ) EM / HEM / PM 300 mg bid (VRCJP96503) 41 b)
27 1.8.2 Page Plasma µ concentration of voriconazole (ug/ml) Present Absent %50%75% 25% 75% PK PK PD PK PD PD 3 A MedDRA NOS NOS NOS NOS NOS
28 1.8.2 Page28 NOS PK 1 PK PK A %50%75% 25% 75% ng/ml 2049 ng/ml 3331 ng/ml ng/ml 2821 ng/ml 1592 ng/ml 2421 ng/ml ng/ml 3
29 1.8.2 Page29 c) 2/3 ASTALTAlP PK/PD ASTAlP Receiver Operating Characteristic CurvesROC 7 2/3 AST /101 (%) /86 8/140 13/261 2/50 19/434 3/76 12/601 6/173 9/ < µ 7 AST d)
30 1.8.2 Page30 (b) a) Plasma µ concentration of voriconazole (ug/ml) EFFECTIVE INEFFECTIVE 8 8 DRC PPS 25%50%75% 25% 75% 1.5 b) 2/3 2/
31 1.8.2 Page31 % (µg/ml) 9 a) a) 2/3 95% n= c) Rex host factor TDM (c) AlP GTP 4401 AlP GTP 28
32 1.8.2 Page /µl /µl ID a) () 16 b) * COSTART c 0001 EM 72 6mg/kg (1) 3mg/kg (25) 150mg (628) PM mg (1) 200mg (25) 100mg (642) mg (1)200mg (24)150 mg (525) 100 mg (2639) 50mg (4060)100mg (6174) PM 64 6mg/kg (1) 3mg/kg (25) 2mg/kg (510) 1.5mg/kg (10 22) PM mg (1) 200mg (24) mg (510)100mg (1184) PM PM PM PM EM EM PM mg (1) 200mg (26) 150mg (713)100mg (1484) 300mg (1) 200mg (24) 150mg (546)100mg (4684) 300mg (1) 200mg (26) 150mg (712)100mg (1285) 6mg/kg (12)3mg/kg (212) 2mg/kg (1235)150mg (3642) 6mg/kg (1) 4mg/kg (24) 3mg/kg (515)150mg (1624) 100mg (2584) 300mg (12) 200mg (25) 150mg (610)100mg (1184) 300mg (1) 200mg (210) 150mg (1127)100mg (2884) 300mg (12) 200mg (25) 150mg (56) 100mg (625) 150mg (2543)200mg (4353) AST 1222 ALT GTP AST 463 ALT 455 AlP 4 GTP 4 LDH 481 a) b) c) 1 Table Table
33 1.8.2 Page33 ID a) 17 () * () COSTART () b) c) 0001 EM 72 6mg/kg (1)3mg/kg (25) 150mg (628) HEM mg (1)200mg (24) () 0101 EM mg (1) 200mg (25) 150mg (58) HEM 68 6mg/kg (1)3mg/kg (213) mg (1441) HEM mg (1)100mg (2) PM 51 6mg/kg (1)4mg/kg (24) PM mg (1)100mg (2) HEM 58 6mg/kg (12)4mg/kg (25) 3mg/kg (615) PM 76 6mg/kg (1)3mg/kg (28) PM 51 6mg/kg (12)3mg/kg (212) 20 2mg/kg (1235) 150mg 42 (3642) HEM mg (1) 200mg (29) mg (1013) HEM mg (1)100mg (210) mg (1)100mg (229) mg (3073) mg (12)200mg (25) 150mg (56)100mg (625) mg (2543) 200mg 3985 (4353) a) b) 1 c) Table Table (d) 3 PK 3 PK PM EM/HEM EM 28 HEM 40 PM 18 PK mg mg/kg 1 2 PM EM/HEM mg mg/kg 1 2 PM mg mg/kg µg/ml EM/HEM PM
34 1.8.2 Page34 PM 20%PM 4.5 µg/ml PM EM/HEM C min A mg 100 mg 150/100 mg 300 mg 150 mg 300/150 mg 300 mg 200 mg 300/200 mg 6 mg/kg 3 mg/kg 6/3 mg/kg 6 mg/kg 4 mg/kg 6/4 mg/kg < 40 kg n=1 CYP2C19 EM (n=28) HEM (n=40) PM (n=18) 40 kg < 40 kg 40 kg < 40 kg n=27 n=8 n=32 n= (96.9) 3185 (100.6) 1887 (88.9) 3405 (94.6) 2319 (48.3) 2436 (72.1) 4726 (75.6) 2236 (86.1) 4071 (94.1) 3148 (84.6) 4670 (36.0) 9821 (36.7) 40 kg n= (43.1) 8260 (50.2) ng/ml%cv (e) TDM 20% CYP2C19 PM µg/ml 4 PK/PD µg/ml
35 1.8.2 Page35 3 PK mg mg/kg 1 2 PM PM 4.5 µg/ml 18 3 PPS µg/ml 4.5 µg/ml µg/ml 6) 3 MITT 19 12
36 1.8.2 Page Pithomyces Bipolaris (1)Table N=
37 1.8.2 Page37 7) kcal 200mg C max AUC 34% 24%T max 1.4 8) a) 40 kg 40 kg 1 6 mg/kg mg mg mg/kg mg mg 1 2 a) CPMP Summary of Product Characteristic 40 kg mg kg mg 1 2
38 1.8.2 Page38 (3) (1) (2) [4.1] (3) [4.2 ] (1) 1 (2) (3) 1 () <30mL/min [ SBECD ]
39 1.8.2 Page39 1. () () 1. (1) (2)Child Pugh C (3) (2)(1)
40 1.8.2 Page40 () (4) 30mL/min50 ml/min[ SBECD [ 6.(3)]] 2. (1) (2) (3) (4) () (5) SBECD 1 3mg/kg 3. CYP 2C192C9 3A4 CYP 2C192C9 3A4 (1) R R R C max 93 AUC 96 CYP3A4 C max 69AUC 78 C max 3.0AUC4.3 CYP3A4 CYP3A4
41 1.8.2 Page41 C max 61AUC 77 R R R R R R R R R R C max 1.4 AUC 1.4 C max 66AUC 82 CYP2C19 CYP2C9 CYP3A4 CYP2C19 CYP2C9 CYP3A4 QT CYP3A4 torsades de pointes CYP3A4 (2) C max 49AUC 69 C max 1.7AUC 1.8 CYP3A4 CYP2C9
42 1.8.2 Page42 HIV NNRTI HMGCoA C max 1.1AUC 1.7 C max 2.2AUC C max 2.2 AUC 3.8 In vitro CYP3A4 In vitro CYP3A4 In vitro CYP3A4 CYP3A4 In vitro CYP3A4 CYP3A4 CYP2C9 CYP2C19 CYP3A4 In vitro CYP3A4 CYP2C9 CYP3A4
43 1.8.2 Page γGTP ASTGOT7.0ALP 7.0ALTGPT (1) 1
44 1.8.2 Page44 10) 11 (2) 5% 15% * ADH /
45 1.8.2 Page45 5% 15% * ALT GPT AST GOT ALP γgtp LDH D FDP * BUN (1) 10mg/kg 100mg/kg (2)
46 1.8.2 Page mg 9. () PTP PTP PTP () g/mL 4.5/mL
200mg 2005 3 876179 2002 3 3 200mg VFEND for Intravenous Use (1) (2) [4.1 ] (3) [4.2 ] (1) [1] (2) (3) [1] 3
50mg 75mg (1) H 3 C O OH HO H O O H OH SO H 3 Na H H N H 2 N NH OH H N O O H H O OH H 3 C H O O N H H H HO H NH CH 3 HN HO H OH O H OH H NH
3240 14 8 8 50mg 75mg 13 6 25 1-(1) H 3 C O OH HO H O O H OH SO H 3 Na H H N H 2 N NH OH H N O O H H O OH H 3 C H O O N H H H HO H NH CH 3 HN HO H OH O H OH H NH O N O C 56 H 70 N 9 NaO 23 S 1292.26 5-[(1S,2S)-2-
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2 129-B*-006P 129-B*-007P C*-004P 129-D*-001P ADH B*-006P B*-007P C*-004P D*-001P Na
2.7.4 2.7.4.1 2.7.4.1.1 11 ADH 1 ADH 1 4 7 129-A*-003 129-B*-001 129-E*-001P 129-G*-001 129-H*-002 129-H*-004 129-H*-005 132 242 4 129-B*-004 129-C*-005P 129-H*-003 129-H*-006 44 ADH ADH 129-C*-001P 16
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β Key words Candida albicans albicans Candida C. albicans Candida glabrata Candida krusei albicans Candida C. glabrata C. albicans albicans Candida β in vitro in vivo C. glabrata C. krusei I β γ µ Candida
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