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  ű ǰ   2017-08-04 3:43:14

					

					
 

HL 17-27 

ǰ

ű ǰ ˷帮 ῡ Ͻñ ٶϴ.

229. Ÿ ȣ

Nintedanib

BNTNBA 100mg(nintedanib esylate 120.4mg)/Cap Ofev(ΰ) (229) ޿
BNTNB 150mg(nintedanib esylate 180.6mg)/Cap Ofev(ΰ) (229) ޿

[] ڼü(PDGFR , ) Ƽڼü(FGFR 1, 2, 3), Ǽ ڼü(VEGFR 1, 2, 3) ϴ tyrosine kinase ̷ ü ATP Ͽ Ͽ Ƽ , ̵, ȭ ߿ signaling .

[ȿ] Ư߼ ġ.

[] : 150mg 1 2ȸ(12ð ) . ȯ(Child Pugh A), : 100mg, 1 2ȸ. : ð 뷮 (Max. 300mg/day).

[] , , , , Ŀ尨, ü߰, ȿ , , , ջ, , , ǰ.

[ݱ] ι ִ ȯ, Ӻ , ߵ~(Child Pugh B, C) ȯ.

[] ó ġ , ӽ ˻ . , , , , , . õ, , QT ȯ, ֱ , ȯ. P-gp (ڳ, θ̽, Ŭν ), P-gp ü(ǽ, īٸ, , St. Johns Wort ) . ġ ݿϵ ȳϰ, ġⰣ (21% ҽŴ). ӱ Ⱓ ּ 3 ̻ .

[Ӻ] FDA D.

 

421. ׾Ǽ

Trastuzumab

ITSMSC 600mg/5ml Vial Herceptin solution for injection(ν) (421)

[] Human epidermal growth factor receptor 2 ܹ(HER2) domain ϴ Ŭ ü HER2 ϴ ü Ÿ.

[ȿ] HER2 缺 ̼ : ̼ ȯ 1ȸ Ǵ ̻ ȭп ġḦ ִ ȯڿ ܵ, ̼ ȯ ȭп ġḦ ȯڿ ŬŹ Ǵ Ź , Ʈָ ȣ ü 缺 ȯڿ ƷθŸ . HER2 : Ǵ ȭп(ʿ 缱) , ҷ ŬĹ̵ ȭп ŬŹ Ǵ Ź , Ź īöƾ ȭп , ( ) ȯ Ǵ > 2 翡 ȭп ܵ .

[] 3ָ 5ml(600mg), 2~5а SC. ¿ ֻ( ֻߴ 2.5cm̻ ). ̼ , 1Ⱓ Ǵ ñ (1 ̳).

[] ɱ (кȭ, ұĢ ڵ, ɺ), ԰ , ׵(ȣ߱, , , ), (εο, ), ̻(ȣ, ħ, õ, , õ), ü߰, Ŀ, Ҹ, , , ̻, ̰̻, , , ȸȫ, , , , , , , , ȫ, , Ż, , , , , Ƿ, ߿, ʺ .

[ݱ] , ġ ܹ, ˷δϴ ι ִ ȯ, ༺ Ǽ翡 ȣ Ǵ Һ ʿ ȯ.

[] ɱ : ƮŬ ๰ ȯ Ǵ , ȯ, ȯ 輺 ū ȯ, ɺ ִ ȯ, 󵿸ȯ, ȯ շ. ½ɽǹ(LVEF) ġ ġ 10 ejection point ̻, 50% ̸ . LVEF ʰų, ļ ɺ ߻ ߴ. ó ֻ ֻ 6ð, ķδ ֻ 2ð ͸. (2~8). (ִ 30) 6ð ̳ , ֻ⿡ 48ð (2~8).

[Ӻ] FDA D.

   

2017. 08. 04 

      ǰ ( 9561)