OYSIENDX Osimertinib 80mg

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Key Highlights

EGFR TKI , EGFR TKI T790M , PFS 18.9 10.1 ,

Service Promise

Direct from JapanLicensed PharmacyPharmacist CheckedEditable in Admin

Specifications

Specification
80mg*30 tablets

Product Info

English Name
Osimertinib 80mg
Chinese Name
OYSIENDX
Generic Name
OYSIENDX

Specifications

Specification
80mg*30 tablets

Full Details

Indications

OYSIENDX , (NSCLC) (EGFR) • • , • • EGFR (TKI) , OYSIENDX OYSIENDX

How It Works

12.1 How It Works (EGFR) , 9 EGFR T790M L858R 19 , AZ7550 AZ5104, 10% , AZ7550 , AZ5104 19 T790M 8 EGFR 15 , HER2 HER3 HER4 ACK1 BLK

Pharmacology

12 12.1 How It Works (EGFR) , 9 EGFR T790M L858R 19 , AZ7550 AZ5104, 10% , AZ7550 , AZ5104 19 T790M 8 EGFR 15 , HER2 HER3 HER4 ACK1 BLK , HER2 HER3 HER4 ACK1 BLK

Dosage

• OYSIENDX • , OYSIENDX • OYSIENDX 1 • OYSIENDX • OYSIENDX, • OYSIENDX o OYSIENDX 60 2 o OYSIENDX , OYSIENDX o OYSIENDX o 120 240 4 8 , OYSIENDX

Precautions

5 Precautions • (ILD)/ ILD/ TAGRISSO , ILD/ , TAGRISSO 1 ILD/ , TAGRISSO, ≥2 ILD/ , TAGRISSO (2.5, 5.1) • QTc QTc , QTc , , , ,

Drug Interactions

7 CYP3A , CYP3A4 , TAGRISSO 160 mg (2.5, 7.1) 7.1 CYP3A CYP3A4 TAGRISSO , TAGRISSO [ (12.3)] TAGRISSO CYP3A

Adverse Reactions

OYSIENDX , • , • , OYSIENDX • • • • • • • • • • • , , OYSIENDX , ,

Package Insert

Indications

OYSIENDX , (NSCLC) (EGFR) • • , • • EGFR (TKI) , OYSIENDX OYSIENDX

Dosage

• OYSIENDX • , OYSIENDX • OYSIENDX 1 • OYSIENDX • OYSIENDX, • OYSIENDX o OYSIENDX 60 2 o OYSIENDX , OYSIENDX o OYSIENDX o 120 240 4 8 , OYSIENDX

Adverse Reactions

OYSIENDX , • , • , OYSIENDX • • • • • • • • • • • , , OYSIENDX , ,

Precautions

5 Precautions • (ILD)/ ILD/ TAGRISSO , ILD/ , TAGRISSO 1 ILD/ , TAGRISSO, ≥2 ILD/ , TAGRISSO (2.5, 5.1) • QTc QTc , QTc , , , ,

Use in Pregnancy and Lactation

8.1 How It Works[ (12.1)],TAGRISSO TAGRISSO , , 1.5 , ,

Drug Interactions

7 CYP3A , CYP3A4 , TAGRISSO 160 mg (2.5, 7.1) 7.1 CYP3A CYP3A4 TAGRISSO , TAGRISSO [ (12.3)] TAGRISSO CYP3A

Clinical Pharmacology

12 12.1 How It Works (EGFR) , 9 EGFR T790M L858R 19 , AZ7550 AZ5104, 10% , AZ7550 , AZ5104 19 T790M 8 EGFR 15 , HER2 HER3 HER4 ACK1 BLK , HER2 HER3 HER4 ACK1 BLK

Pharmacology and Toxicology

13 13.1 2 , 1 3 10 mg/kg/ 10 mg/kg/ 80 mg AUC 0.2 / rasH2 26 , 10 mg/kg/ , Ames , ,TAGRI

Clinical Studies

14 14.1 EGFR (NSCLC) TAGRISSO (ADAURA [NCT02511106]) EGFR 19 21 L858R NSCLC , [AJCC] 7 IB IIIA , , cobas® EGFR EGFR 19 21 L858R /

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Description

Indications

OYSIENDX , (NSCLC) (EGFR) • • , • • EGFR (TKI) , OYSIENDX OYSIENDX

How It Works

12.1 How It Works (EGFR) , 9 EGFR T790M L858R 19 , AZ7550 AZ5104, 10% , AZ7550 , AZ5104 19 T790M 8 EGFR 15 , HER2 HER3 HER4 ACK1 BLK

Pharmacology

12 12.1 How It Works (EGFR) , 9 EGFR T790M L858R 19 , AZ7550 AZ5104, 10% , AZ7550 , AZ5104 19 T790M 8 EGFR 15 , HER2 HER3 HER4 ACK1 BLK , HER2 HER3 HER4 ACK1 BLK

Dosage

• OYSIENDX • , OYSIENDX • OYSIENDX 1 • OYSIENDX • OYSIENDX, • OYSIENDX o OYSIENDX 60 2 o OYSIENDX , OYSIENDX o OYSIENDX o 120 240 4 8 , OYSIENDX

Precautions

5 Precautions • (ILD)/ ILD/ TAGRISSO , ILD/ , TAGRISSO 1 ILD/ , TAGRISSO, ≥2 ILD/ , TAGRISSO (2.5, 5.1) • QTc QTc , QTc , , , ,

Drug Interactions

7 CYP3A , CYP3A4 , TAGRISSO 160 mg (2.5, 7.1) 7.1 CYP3A CYP3A4 TAGRISSO , TAGRISSO [ (12.3)] TAGRISSO CYP3A

Adverse Reactions

OYSIENDX , • , • , OYSIENDX • • • • • • • • • • • , , OYSIENDX , ,

Additional information

Specification

80mg*30片