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.
The maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer, whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
The treatment of patients with locally advanced or metastatic non- small cell lung cancer after failure of at least one prior chemotherapy regimen.
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Single oral doses of Erlotinib up to 1,000 mg in healthy subjects and weekly doses up to 1,600 mg in cancer patients have been tolerated. Repeated twice-daily doses of 200 mg single-agent Erlotinib in healthy subjects were poorly tolerated after only a few days of dosing. Based on the data from these studies, an unacceptable incidence of severe adverse reactions, such as diarrhea, rash, and liver transaminase elevation, may occur above the recommended dose.
MOST COMMON SIDE EFFECTS
Metastatic NSCLC – First-Line Treatment of Patients With EGFR Mutations:
Most frequent (≥30%) adverse reactions were diarrhea, asthenia, rash, cough, dyspnea, and decreased appetite.
Advanced NSCLC – Maintenance Treatment:
Rash and diarrhea.
Rash (9%) and diarrhea (2%). Rash and diarrhea resulted in dose reductions or interruption (5% and 3%, respectively) and discontinuation (1% and 0.5%, respectively) of Erlotinib-treated patients.
Advanced NSCLC – Second/Third-Line Treatment:
Rash and diarrhea.
Rash (9%) and diarrhea (6%). Rash and diarrhea each resulted in dose reductions (6% and 1%, respectively) and discontinuation in 1% of Erlotinib-treated patients.
Advanced Pancreatic Cancer –Erlotinib Administered Concurrently with Gemcitabine:
Fatigue, rash, nausea, anorexia, and diarrhea.
Grade 3/4 (NCI-CTC Version 2.0) adverse reactions were rash (5%) and diarrhea (5%). Rash and diarrhea each resulted in dose reductions in 2% of patients and discontinuation in up to 1% of patients receiving Erlotinib plus gemcitabine.