아바스틴 베바시주맙 - roche.co.kr

1 Version: Korea Product Information ( ).. 1 . : ( ) 25mg : a,a- . : . : . ( ) : 20. : .. : . - . 1 . 2 - - .. - 1 . - 1 .. 12 .. - , 1 .. - EGFR , 1 .. - 1 -2a .. - . , . - (FIGO stages B, C ) , front-line .. - VEGF VEGF - (platinum- sensitive) , . - (platinum-sensitive) , .. - VEGF VEGF - 2 . (platinum-resistance) , , . (pegylated liposomal doxorubicin) .. - (persistent), .. 2 1 , 1 5 mg/kg 10 mg/kg (IV infusion) 3 1 , 1 mg/kg 15. mg/kg .. 1 - - .. 2 1 , 1 5 mg/kg 3 1 , 1 mg/kg .. 2 1 , 1 10 mg/kg 3 1 , 1 15 mg/kg .. - 1 . 6 .. 3 1 , 1 mg/kg 15 mg/kg .. -EGFR 1 . Version: Korea Product Information 3 1 , 1 15mg/kg .. 2 1 , 1 10 mg/kg .. 2 1 , 1 10 mg/kg . , . - Front-line : 2 6 , 15 ( ).. 3 1 , 1 15 mg/kg . - : 6-8 . 6-10.

2 3 1 , 1 15 mg/kg . - : , ( 1 ) .. 2 1 , 1 10 mg/kg . ( 3 1-5 . ) 3 1 , 1 15mg/kg .. 3 1 , 1 15. mg/kg .. 90 . 60 .. 60 30 . (intravenous bolus or push) . 11. , .. , ( 1. ).. - : . - : 18 .. - : .. 1.. 1) .. , ( - ) .. 2) .. 4 .. 3) .. 28 .. , , .. 4) .. 5) (PRES).. , , , ( . ). PRES ( MRI) . PRES .. PRES . Version: Korea Product Information 6) .. 1 .. dipstick .. 4 ( ) .. 7) . 5 (CVA), (TIA) .. 65 , .. 8) .. (4 ) .. 3 .. , . 9) . (Imaging Procedure) / , .. , . 3 4 .. , , .. 3 .. 10) .. 11) / . / . / ( ml ) . 12) . , , . ( ) / .. 13) , . / .. 14) .. 15) .. , . , , , , .. 16) .. 2.. 1) . 2) CHO . 3) . 3.. 1) .. / .. , , .. - . 2) .. 1 10%(NCI-CTC 1-5 ) 2%(NCI-CTC 3-5 . ) .. ( 10%) ( 1%-<10%).. Version: Korea Product Information.

3 (pegylated liposomal doxorubicine) (palmar-plantar erythrodysaesthesia syndrome), . , , .. NCI-CTC 3-5 . ( 1 . ( 1 2% ). 10% ).. ( ) .. ** .. *.. (Lethargy) .. * AVF3077s (NSABP C-08) 295 . ** - . 3) .. 1% , , , 2% , ( . ) .. Version: Korea Product Information , (GOG-0240) ( ) . (pelvic radiation) . 3 1 .. X-ray ( ) .. , , . 2% .. , - , . (pelvic radiation) . - . (diverting ostomies) .. , (GOG-0240) , . , . ( 1% ) ( . ).. 1 1 , . 6 .. 28 3 .. 28-60 .. 60 .. 10%(4/40) 20%(3/15) . , . ( 3 (< )). , . 3-5 .. 3-5 .. (AVF3708g) ( ) .. (BO21990) Grade 3-5 ( ) .. , , 3 . (BO21990) , 3-5 . , .. JO25567 , ( ) ( 14% vs.. ). 3 4 ( ) .. 4 ( ) .. JO25567 EGFR 1 . , . 3 . , . 4 5 . ACE , .. , . (PRES). (AVF4095g, OCEANS) 2 ( ) PRES.

4 , , . 1 . 3 . 4 ( ) .. 1 .. 2 g/24hr 2 g/24hr .. NCI-CTC 3-5 .. ( ) .. / . , / , , , , , . cavitation .. 5% .. 3-5 . 1% . / 3 2 .. (glioblastoma).. Version: Korea Product Information . 13 96 1 (1%) . (5 ) , 91 3 ( ) ( 4 ) .. 2 ( 800 ) 83 . 2 ( ) .. AVF3708g (1 ) . (2/84) (1, 2 4 ) (3/79) . 50% . NCI-CTC 1 5 .. ( , ) .. , , .. , .. ( ) .. (AVF2192g) (6/104) . 11%(11/100) . (AVF3708g) . (4/84) (5/79) .. , . , . 3-5 .. , (GOG-0240) 3-5 .. (BO21990) 3-5 .. 3 (AVF2119g, E2100, BO17708, AVF3694g, AVF3693g) 3 .. AVF3694g 3 .. + : , + : 0%. AVF3694g + ( ) + ( ) . / . NYHA II-IV .. B / / / / (R-CHOP)+ . / / / / (R-CHOP) 3 300. mg/m2 .. +R-CHOP .. , . 2%. 3 4 . , , , , , (Normalized Ratio) .. ( , ).. , .. ( 5% ).. 3 , FSH level 30 mIU/mL, -HCG.

5 ( *). , , .. ( **).. (PRES)( **). ( ). ( ). ( ). ( **). ( ). ( ). , ( ) : .. - / , / / , , , , / . Version: Korea Product Information 4. ( , ), , . 1,5( ), ( ), ( ), ( ), . ( ), ( ).. 1. ( (adjusted HR , 99% CI : , . ) 1 100 , 1 100 ), . (adjusted HR , 99% CI : , 1 100 , 1 100 . ). 5. / .. 1 (adjusted HR , 99% CI : , . 1 100 , 1 100 ), (adjusted HR.. , 99% CI : , 1 100 , 1 100 ).. ( 2.. ).. 3 . (adjusted risk ratio , 95% CI : , , ).. 6. , , ( ). *.. 1. Gower et al. Adverse Event Rates Following Intravitreal Injection of avastin or Lucentis for Treating Age-Related Macular Degeneration ARVO 2011, Poster 6644, Data on file 2. Curtis LH, et al. Risks of mortality, myocardial infarction, bleeding, and stroke associated with therapies for age-related macular degeneration.

6 Arch Ophthalmol. 2010;128(10):1273-1279. 3. CATT Research Group, Ranibizumab and Bevacizumab for Neovascular Age-Related Macular Degeneration. 4. 1 . 5. / . 6. - (non-company clinical trials) , CTC .. **. (<1/10,000). **. ( 1/10,000~<1/1,000). **. ( 1/100~<1/10). 4) . (1) 6 602 , (411 /602 , 1817 ) . , (294 /602 , 1096 ) , (72 /602 , 90 ), (66 /602 , 78 ), (64 /602 , 85 ), (54 /602 , 99 ), . (42 /602 , 58 ), (40 /602 , 57 ), (36 /602 , 46 ), (35 /602, 39 ), . , , , , , , , , , , . , , , , , , , , , , , . (20 /602 , 26 ) 5 , 2 , . 2 , 2 , , , , , , , , , , , , , , 1 . (5 /602 , 5 ), 2 , 1 , 1 , 1 . (195 /602 , 438 ) , (110 /602 , 207 ) , 25 , 12 , 11 , 9 , 8 , AST , 6 , ALT , , , 5 , , , / , 4 , ALP , , , , , , , , , 3 , , , , , , , , , , , , , 2 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , 1.

7 (11 /602 , 12 ) , 5 , , , , , , , 1 .. (1 /602 , 1 ) , 1 . (2) . ( ) , .. : , . - : . : . : , , . : , . : , , . : . : , . Version: Korea Product Information 4.. 1) : (<3%) .. , , , , 3 , , , .. 2) : 28 .. 20 . 3) : .. 5 , - , . , .. 4) : .. 500 ELISA . - . 5) 6 . 6) 1 (PFS) (OS) .. 7) 2 , . , (PFS) (OS) .. 8) . 5.. 1) : .. -2a, (IFL, 5-FU/LV, - , , / ) .. 2) : -2a, ( OSI-420), . ( SN38), , ( ), .. 3) ( ), 921 . , , 3 BO21990 .. 4) : 2 ( 2 10 mg/kg ) (1 50 mg) . 19 7 (Microangiopathic Haemolytic Anaemia, MAHA) . MAHA . , . ( ), .. 6.. 1) : .. IgG .. 6 .. 295 .. 2) : . IgG . 6 . 7.. 18 .. 2 . ( . ) .. 18 . mg/kg .. 8.. 65 (CVA), (TIAs) .. 65 3-4 . , , , , . 65 3 . 65 .. 65 65 , , , , 5% .. ( AVF2107) , , , 65 . 65 . 9.

8 1) 2 3 .. 2) . dipstick 2+ . 24 . Version: Korea Product Information 10.. (20 mg/kg IV) 16 9 16 3 .. 11.. mg/ml .. 2-30 48 . , .. 2-8 24 .. 12.. 1) (2-8 ) .. 2) . 13.. - 26 cynomolgus .. - . - .. , / .. - . , .. 2 5 mg/kg 3 . - AVF2107g, AVF0780g, AVF2192g, E3200, NO16966 5- , 5- , FOLFOX, XELOX . 1 . ML18147 2 - . - . - , 1 E4599 . , BO17704 .. , 2-8 .. 4mL, 16mL 1 .. , , .. (2017 05 08 ) ( ) . ( ) .. : 2005 03 09 , : 2017 05 08 .. ( ). Roche Pharma(Schweiz). Schoenmattstrasse 2 4153 Reinach, Switzerland ( ).. Genentech Inc. 1 Antibody Way Oceanside, CA 92056, USA. Roche Singapore Technical Operations, Pte. Ltd. 10 Tuas Bay Link, Singapore 637394. / . Genentech Inc. 1 DNA Way South San Francisco CA 94080-4990, USA.

9 F. Hoffmann-La Roche Ltd. Grenzacherstrasse 124 CH-4070 Basel, Switzerland . Genentech Inc. 4625 NW Brookwood Parkway, Hillsboro, OR 97124, USA. / (2 ). Roche Diagnostics GmbH. Version: Korea Product Information Sandhofer Strasse 116, D-68305 Mannheim, Germany F. Hoffmann-La Roche Ltd. Wurmisweg CH-4303 Kaiseraugst, Switzerland .. 411(Tel. 02-3451-3600).