ERDADX Erdafitinib 4mg

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Key Highlights

ERDADX , • “FGFR” • , FGFR , ERDADX ERDADX

Service Promise

Direct from JapanLicensed PharmacyPharmacist CheckedEditable in Admin

Specifications

Specification
4mg*56 tablets

Product Info

English Name
Erdafitinib 4mg
Chinese Name
ERDADX
Generic Name
ERDADX

Specifications

Specification
4mg*56 tablets

Full Details

Indications

ERDADX , • “FGFR” • , FGFR , ERDADX ERDADX

How It Works

12.1 How It Works , , FGFR1 FGFR2 FGFR3 FGFR4 FGFR , FGFR FGFR

Pharmacology

12 12.1 How It Works , , FGFR1 FGFR2 FGFR3 FGFR4 FGFR , FGFR FGFR 12.2 187 , QTc , QTc >20 BALVERSA FGFR [ Dosage (2.3) ]

Dosage

2 BALVERSA , FGFR3 (2.1) 8 mg, , 9 mg (2.2) , (2.2) 2.1 FDA , FGFR3 , BALVERSA [ (14.1)] FDA FGFR3 , BALVERSA 8 mg 4 mg , 9 3 ,

Precautions

5 Precautions BALVERSA / (CSR/RPED) , , , CSR/RPED, BALVERSA 4 4 , (2.3, 5.1) BALVERSA , (2.3, 5.2) -

Drug Interactions

7 CYP2C9 CYP3A4 (7.1) CYP3A4 BALVERSA (7.1) CYP3A4 BALVERSA 9 mg (7.1) , (2.3, 7.1) P-gp P-gp ,BALVERSA 6

Adverse Reactions

• ERDADX , , 2 , ERDADX , • ERDADX , ERDADX 14 21 , , ERDADX • • • • • • • • • • • • • • • • • • • , “ ” , , ERDADX , ERDADX ,

Package Insert

Indications

ERDADX , • “FGFR” • , FGFR , ERDADX ERDADX

Dosage

2 BALVERSA , FGFR3 (2.1) 8 mg, , 9 mg (2.2) , (2.2) 2.1 FDA , FGFR3 , BALVERSA [ (14.1)] FDA FGFR3 , BALVERSA 8 mg 4 mg , 9 3 ,

Adverse Reactions

• ERDADX , , 2 , ERDADX , • ERDADX , ERDADX 14 21 , , ERDADX • • • • • • • • • • • • • • • • • • • , “ ” , , ERDADX , ERDADX ,

Precautions

5 Precautions BALVERSA / (CSR/RPED) , , , CSR/RPED, BALVERSA 4 4 , (2.3, 5.1) BALVERSA , (2.3, 5.2) -

Use in Pregnancy and Lactation

8.1 How It Works ,BALVERSA [ (12.1)] BALVERSA , , , , AUC , -

Drug Interactions

7 CYP2C9 CYP3A4 (7.1) CYP3A4 BALVERSA (7.1) CYP3A4 BALVERSA 9 mg (7.1) , (2.3, 7.1) P-gp P-gp ,BALVERSA 6

Clinical Pharmacology

12 12.1 How It Works , , FGFR1 FGFR2 FGFR3 FGFR4 FGFR , FGFR FGFR 12.2 187 , QTc , QTc >20 BALVERSA FGFR [ Dosage (2.3)]

Clinical Studies

14 14.1 FGFR3 BLC3001 NCT03390504 1 BALVERSA , 266 FGFR3 , 1:1 , BALVERSA 8 mg, 9 mg 75 mg/m², 3 320 mg/m², 3 , ECOG 0 1 vs. 2 vs.

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Description

Indications

ERDADX , • “FGFR” • , FGFR , ERDADX ERDADX

How It Works

12.1 How It Works , , FGFR1 FGFR2 FGFR3 FGFR4 FGFR , FGFR FGFR

Pharmacology

12 12.1 How It Works , , FGFR1 FGFR2 FGFR3 FGFR4 FGFR , FGFR FGFR 12.2 187 , QTc , QTc >20 BALVERSA FGFR [ Dosage (2.3) ]

Dosage

2 BALVERSA , FGFR3 (2.1) 8 mg, , 9 mg (2.2) , (2.2) 2.1 FDA , FGFR3 , BALVERSA [ (14.1)] FDA FGFR3 , BALVERSA 8 mg 4 mg , 9 3 ,

Precautions

5 Precautions BALVERSA / (CSR/RPED) , , , CSR/RPED, BALVERSA 4 4 , (2.3, 5.1) BALVERSA , (2.3, 5.2) -

Drug Interactions

7 CYP2C9 CYP3A4 (7.1) CYP3A4 BALVERSA (7.1) CYP3A4 BALVERSA 9 mg (7.1) , (2.3, 7.1) P-gp P-gp ,BALVERSA 6

Adverse Reactions

• ERDADX , , 2 , ERDADX , • ERDADX , ERDADX 14 21 , , ERDADX • • • • • • • • • • • • • • • • • • • , “ ” , , ERDADX , ERDADX ,

Additional information

Specification

4mg*56片