インフリキシマブBS点滴静注用100mg「日医工」

1 2020 10 2 . 2020 4 . 87239. 2 8 22900 AMX00955000. 5 2017 11 . TNF .. 2 . BS 100mg . Infliximab BS for Infusion 100mg Nichiiko .. 1.. - .. CT .. 2.. Infusion reaction . 2 . infusion reaction .. infusion reaction . 3.. BS 100mg . 3 . 1 .. 2 .. 100mg . 1 . / 500mg 80 .. TNF .. 1 .. BS 100mg . 2 1kg 5mg 1 . 2 6 8 . pH 10mL . 6 .. 10mL . 1 1kg 8 . 10mg 6mg . 4. 4 .. 2 1kg 5mg 1 . 2 6 6 8 .. 2 1kg 5mg 1 . 2 6 8 . 6 .. 1kg 10mg 1 . 5. 1kg 5mg 1 . 4 .. 2 1kg 5mg 1 . 2 6 8 .. 7.. 10% .. 6mg/ .. 2 6 10mg/kg . 5- . 10mg/kg .. 1.

2 14 . 14 . 5- .. TNF .. TNF . 6.. 2 6 10mg/kg . 2 1kg 3mg 1 . 2 6 8 . 6 .. 1 . 1kg 8 10mg . 6mg 2 6 . 4 .. 10mg/kg . 5mg/kg 8 . 2 1kg 5mg 1 . 2 6 8 .. 2 6 8 .. 2 . 8. B HBs . 5mg/kg HBc HBs . 8 12 . B . TNF B . - B . CT .. 1 .. TNF B . B . 2 .. infusion reaction Infusion Reaction .. 3 .. TNF . TNF .. 3 .. TNF .. 6 . infusion reaction .. 9.. 11.. 1 . 2 1 1 .. 2 .. infusion reaction .. - .. 3 . 5% 1% 5% 1% .. CT . X. -D CT . PaO 2 KL-6 .. ALP .. AST ALT -GTP LDH .. 3 . B U N .. dsDNA . dsDNA .. CK .. 5% 1% 5% 1% .. CRP.

3 I g A .. CK .. 4 . 5% 1% 5% 1% infusion reaction .. DNA . 15.. 62 1 . 102 2 . 2 .. 150 . 35% NYHA / . 5 10mg/kg 2 6 3 . 10mg/. kg . 28 10mg/kg . 3 5mg/kg 1 . 10mg/kg 51 11 5mg/kg 50 3 49 5 . 1 10mg/. kg 8 5mg/kg . 4 .. 3 5 .. 169 .. 1 3 .. NIH SEER National Institute of Health NIH Surveillance, Epidemiology, and End Results SEER . database 1 .. 21 . 1 . 14.. 1.. 3 . a . 1 21-G . 1 10mL . a. 97 0 . b. 96 1 NA. 2 5 c. 96 1 a c b 96 1 . 3 a .. a. 4094 2 4 . b. 4085 8 NA.. 250mL c. 4055 19 25kg 50mL 25kg 100mL a c b 4055 21 100kg a 3.

4 2 4mg/mL b NIH SEER database .. 2 . 2 4mg/mL 50 . 10 .. 2 .. 6 infusion reaction .. 1 5mg/kg .. 5 . 2.. a .. a. 1626 0 b. 1611 6 NA. c. 1604 10 a c b 1604 10 . a .. a. 6391 9 . 100 . b. 6357 24 NA . 100 . c. 6343 41 . a c b 6331 50 1 . 5mg/kg 3 0 2 6 . a 3 5 10 14 8 . 8 . b NIH SEER database .. 3 . 106 . 15 . 3.. a .. a. 2906 1 b. 2887 12 NA. c. 2877 14 0 C1H 14 Cpre 30 Cpre 54 . a c b 2877 15 . 5mg/kg . n 31 38 a .. C1H 1 Cpre g/mL . 2 . a. 17852 14 5mg/kg 8 5mg/kg 8 . b. 17721 67 NA g/mL 10mg/. kg 10mg/kg 8 . c. 17720 92 g/mL.

5 A c b 17707 106 a 3 5 .. b NIH SEER database .. TNF .. TNF .. 16.. 1 . 0 Cpre 0 C1H 8 Cpre 16 Cpre 40 . n=48 100. n=48 3mg/kg . 10mg/kg 0 8 . n 26 39 AUCt 100 . 90% C1H 1 Cpre g/mL . 100 2 3 . 100 5mg/kg 8 19 5mg/kg 4 . 4 . AUCt 0-8 Cmax 40 .. g h/mL g/mL . 48 100 48 6 . 1 3 2 7 5 1 0 4 . NONMEM version VI . 0 Cpre 0 C1H 4 Cpre 8 Cpre 40 .. 5mg/kg 3 .. n 4 19 ATTRACT .. 3 10mg/kg 2 6 . C1H 1 Cpre g/mL 4 8 102 . 0 . 4 3mg/kg 4 73 10 3mg/kg 8 . 5mg/kg Cmax 118 g/mL 71 8 10mg/kg 4 74 1. Vd 10mg/kg 8 77 6 .. Vd 2 1 10mg/kg.

6 17% . 5mg/kg 1 . 20 2 5 10mg/kg 2 6 8 46 . 5mg/kg 2 6 . AST ALT 5 10mg/kg . 5mg/kg 8 . 31 1 .. 0 C1H 2 Cpre 6 Cpre 30 Cpre 54 . 5mg/kg 0 C1H 2 Cpre 6 Cpre 14 . n 3 4 . 5mg/kg 168 10mg/kg . n 28 30 113-206 n 3 4 . 10mg/kg C1H 1 Cpre g/mL .. n 29 32 274-419 3 1 5mg/kg . C1H 1 Cpre g/mL . 1 . 1 5mg/kg 2 6 . 6mg/ 3 10mg/kg 2 6 8 62 . 5mg/kg 35 . 8 . BMI 5mg/kg 2 6 . 8 46 14 54 8. 3mg/kg 49 g/mL g/mL . 2 10mg/kg 50 4 5mg/kg 64 19 .. 0 C1H 2 Cpre 6 Cpre 14 . 3mg/kg 0 C1H 14 Cpre 30 Cpre 70 . n 49 . 10mg/kg . 5mg/kg n 48 51.

7 N 27 35 . C1H 1 Cpre g/mL . 2 C1H 1 Cpre g/mL . 6mg/ 3mg/kg 2 6 2 . 3mg/kg 6mg/kg 10mg/kg 8 5mg/kg 8 . 5mg/kg 8 . 3mg/kg 99 27 6mg/kg 104 24 10mg/ g/mL 10mg/kg . kg 104 13 10mg/kg 40 8 . g/mL . 0 C1H 14 C1H 22 Cpre 54 . 3mg/kg n 86 99 . 6mg/kg . n 91 104 . 10mg/kg n 95 104 C1H 1 Cpre g/mL . 3mg/kg 6mg/kg 8 22 . ACR 20% 4 . 1 3mg/. kg 6mg/kg g/mL .. 7 .. 100 . TNF 35S 10mg/kg . 14 .. 100 .. 1 5mg/kg 3 0 2 6 10 . 14 8 . 8 . 5mg/kg 14 .. 0 Cpre 0 C1H 8 Cpre 16 Cpre 40 .. 10mg/kg . n 51 44 . C1H 1 Cpre g/mL . 5mg/kg 8 6mg/kg 4.

8 4 g/mL .. 4 5 8 7 9 0 . NONMEM ver.. 0 C1H 14 Cpre 30 Cpre 54 . 1 .. 5mg/kg 2 6 6 42 5mg/kg . 5mg/kg n 8 14 . 33 2 . C1H 1 Cpre g/mL . 2 5mg/kg 8 5 . 10mg/kg 8 . 10mg/kg 5 .. 0 Cpre 0 C1H 8 Cpre 16 .. 10mg/kg . n 3 5 . C1H 1 Cpre g/mL . 10mg/kg 0 . 3 5mg/kg 2 6 8 . 22 . 5mg/kg 21 . 0 C1H 24 Cpre 48 .. 5mg/kg . n=32 33 . C1H 1 Cpre g/mL .. 1 . 5mg/kg 2 6 8 22 . 5mg/kg . 104 10 . 0 C1H 6 Cpre 14 Cpre 22 Cpre 30 .. 5mg/kg . n 14 21 . C1H 1 Cpre g/mL . 17.. 0 C1H 6 Cpre 14 Cpre 22 Cpre 30 .. 5mg/kg . n=62 104 100 3mg/kg 14.

9 C1H 1 Cpre g/mL 10mg/kg DAS28-ESR 14 . 2 DAS28-ESR . ACT1 5mg/kg 2 6 n=123 100 n=111 . 8 46 14 DAS28-ESR . 5mg/kg 116 9 100 . 95% . 100. 100 3 . TNF 35S 100 . 10mg/kg . 1 . 25 1 3 5 10mg/kg . 100 5mg/kg IOIBD 4 2 . TNF 35S 10mg/kg 1 5 4 CDAI 4 . 70 4 3 4 . IgG1 5mg/kg 5/7 3/7 . 8 . 2 54 ACR 20% MTX . 5mg/kg 2 6 10 CDAI 25% 15/88 36/86 . 70 57 6 p . 8 46 4 50 54 X . 54 47/57 CDAI 150 Sharp Score . 4 4 . 15/18 10/18 p . 57/64 DNA 54 ADL HAQ. 34/64 . 3 p . 5mg/kg 8 39 QOL SF-36 . 10mg/kg 8 32 8 10mg/kg . CDAI p . 33 40 26 55/88 5mg/kg 8 65/71 38/86 13/88.

10 10mg/kg 8 21/39 5mg/kg . DNA 18/71 16/71 10mg/kg 1 . 4/39 DNA 4/39 5mg/kg . 4 2 6 14 . 5mg/kg 2 6 10 PCDAI 15 SD . 30 14 p 14 12 11 . 6 8 46 10mg/kg 7 . 8 46 54 11/12 100% 12/12 DNA . PCDAI 10 9/12 10mg/kg 8 7/12 5/12 . 5mg/kg 8 5 . 10mg/kg 8 8 3/5 1 . 10% . 9/14 DNA PASI Psoriasis Area and Severity Index 12 . 7/14 5mg/kg 2 6 . 10 PASI 75% 0/19 . 1 / 24/35 p . 10% PASI 12 . 5mg/kg 4 5 CRP . CDAI 70 17% 4/24 45 . 5mg/kg 81% 22/27 5 5mg/kg 2 6 8 46 . 12/27 6/25 . 2/27 PASI 75% 20/37 ACR 20% . 2/27 10/12 . 2 ACCENT 4/7 7/8.