G-Nib 250mg Tablet

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. 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. Gefitinib tablets are a tyrosine kinase inhibitor 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. Limitation of Use: Safety and efficacy of Gefitinib tablets have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

• Interstitial lung disease (ILD): ILD occurred in patients taking Gefitinib tablets. Withhold Gefitinib tablets for worsening of respiratory symptoms. Discontinue Gefitinib tablets if ILD is confirmed. - Hepatotoxicity: Obtain periodic liver function testing. Withhold Gefitinib tablets for Grade 2 or higher for ALT and/or AST elevations. Discontinue for severe hepatic impairment. - Gastrointestinal perforation: Discontinue Gefitinib tablets for gastrointestinal perforation. - Diarrhea: Withhold Gefitinib tablets for Grade 3 or higher diarrhea. - Ocular Disorders including Keratitis: Withhold Gefitinib tablets for signs and symptoms of severe or worsening ocular disorders including keratitis. Discontinue for persistent ulcerative keratitis. - Bullous and Exfoliative Skin Disorders: Withhold Gefitinib tablets for Grade 3 or higher skin reactions or exfoliative conditions. - Embryo-fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. Interstitial Lung Disease (ILD) ILD or ILD-like adverse drug reactions (e.g., lung infiltration, pneumonitis, acute respiratory distress syndrome, or pulmonary fibrosis) occurred in 1.3% of the 2462 patients who received Gefitinib tablets across clinical trials; of these, 0.7% were Grade 3 or higher and 3 cases were fatal. Withhold Gefitinib tablets and promptly investigate for ILD in any patient who presents with worsening of respiratory symptoms such as dyspnea, cough and fever. Permanently discontinue Gefitinib tablets if ILD is confirmed. Hepatotoxicity In patients who received Gefitinib tablets across clinical trials, 11.4% of patients had increased alanine aminotransferase (ALT), 7.9% of patients had increased aspartate aminotransferase (AST), and 2.7% of patients had increased bilirubin. Grade 3 or higher liver test abnormalities occurred in 5.1% (ALT), 3.0% (AST), and 0.7% (bilirubin) of patients. The incidence of fatal hepatotoxicity was 0.04%. Obtain periodic liver function testing. Withhold Gefitinib tablets in patients with worsening liver function and discontinue in patients with severe hepatic impairment. Gastrointestinal Perforation Gastrointestinal perforation occurred in three (0.1%) of the 2462 Gefitinib tablets-treated patients across clinical trials. Permanently discontinue Gefitinib tablets in patients who develop gastrointestinal perforation. Severe or Persistent Diarrhea Grade 3 or 4 diarrhea occurred in 3% of 2462 Gefitinib tablets-treated patients across clinical trials. Withhold Gefitinib tablets for severe or persistent (up to 14 days) diarrhea. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following adverse drug reactions are discussed in more detail in other sections of the labeling: - Interstitial Lung Disease - Hepatotoxicity - Gastrointestinal Perforation - Severe or Persistent Diarrhea - Ocular Disorders including Keratitis - Bullous and Exfoliative Skin Disorders The most commonly reported adverse drug reactions (ADRs), reported in more than 20% of the patients and greater than placebo were skin reactions and diarrhea. at 484-838-0633 / 484-875-3013 or FDA Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Gefitinib tablets is based on the data from 2462 patients with NSCLC who received Gefitinib tablets 250 mg daily monotherapy in three randomized clinical studies (Study 2, Study 3 and Study 4). Patients with a history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis that required steroid treatment or any evidence of clinically active interstitial lung disease were excluded from these studies. Controlled Studies: Study 2 was a randomized, multicenter, open-label trial in which 1217 patients were randomized to receive first-line treatment for metastatic NSCLC; 607 patients received Gefitinib tablets 250 mg daily and 589 patients received carboplatin/paclitaxel. The median duration of treatment with Gefitinib tablets was 5.9 months. The study population characteristics were: median age 57 years, age less than 65 years (73%), female (79%), Asian (100%), NSCLC adenocarcinoma histology (100%), never smoker (94%), light ex-smoker (6%), ECOG PS 0 or 1 (90%). Study 3 was a randomized, multicenter, double-blind, placebo-controlled trial in which 1692 patients were randomized to receive second- or third-line treatment for metastatic NSCLC; of which 1126 patients received Gefitinib tablets 250 mg daily and 562 patients received placebo. The median duration of treatment with Gefitinib tablets was 2.9 months. The study population characteristics were: median age 62 years, age less than 65 years (60%), female (33%), Caucasian (75%), Asian (21%), NSCLC adenocarcinoma histology (48%), never smoker (22%), ECOG PS 0 or 1 (65%), PS 2 (29%), PS 3 (5%) and two or more prior therapies (51%). Study 4 was a randomized, multicenter, open-label trial in which 1466 patients were randomized to receive second-line treatment for metastatic NSCLC; Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.