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Gefitinib

Gefitinib is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: Gefitinib; Generic name: GEFITINIB; Drug class: Kinase Inhibitor [EPC].

Brand nameGefitinib
Generic nameGEFITINIB
Drug classKinase Inhibitor [EPC]
ManufacturerQilu Pharmaceutical Co., Ltd.
Used for1 INDICATIONS AND USAGE Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [ see Clinical Studies (14) ]. Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [ see Clinical Studies (14) ]. Gefitinib tablets are a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metast
Dosage2 DOSAGE AND ADMINISTRATION Recommended dose is 250 mg orally, once daily with or without food. (2.2) 2.1 Patient Selection Select patients for the first-line treatment of metastatic NSCLC with gefitinib tablets based on the presence of EGFR exon 19 deletions or exon 21 L858R mutations in their tumor or plasma specimens[ see Indications and Usage (1) , Clinical Studies (14) ]. If these mutations are not detected in a plasma specimen, test tumor tissue if feasible. Information on FDA-approved tes
Active ingredient(s)GEFITINIB
RouteORAL
Official labelhttps://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0afc12dd-12f8-4def-9027-f38412a862b9

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