Erlozest Tablet

Erlotinib tablet is a kinase inhibitor indicated for: The 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen First-line treatment of patients with locally advanced, unrespectable or metastatic pancreatic cancer, in combination with gemcitabine. Limitations of Use: Safety and efficacy of Erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. Non-Small Cell Lung Cancer (NSCLC) Erlotinib Tablets was indicated for: The 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Limitations of use: Safety and efficacy of Erlotinib have not been established in patients with NSCLC whose tumors have other EGFR mutations. Erlotinib tablet is not recommended for use in combination with platinum-based chemotherapy. Pancreatic Cancer Erlotinib tablet in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

---

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): Occurs in 1.1% of patients. Withhold Erlotinib tablets for acute onset of new or progressive unexplained pulmonary symptoms, such as dyspnea, cough and fever. Discontinue Erlotinib if ILD is diagnosed. Renal failure: Monitor renal function and electrolytes, particularly in patients at risk of dehydration. Withhold Erlotinib tablets for severe renal toxicity. Hepatotoxicity: Occurs with or without hepatic impairment, including hepatic failure and hepatorenal syndrome: Monitor periodic liver testing. Withhold or discontinue Erlotinib tablets for severe or worsening liver tests. Gastrointestinal perforations: Discontinue Erlotinib tablets. Bullous and exfoliative skin disorders: Discontinue Erlotinib tablets. Cerebrovascular accident (CVA): The risk of CVA is increased in patients with pancreatic cancer. Microangiopathic hemolytic anemia (MAHA): The risk of MAHA is increased in patients with pancreatic cancer. Ocular disorders: Discontinue Erlotinib tablets for corneal perforation, ulceration or persistent severe keratitis. Hemorrhage in patients taking warfarin: Regularly monitor INR in patients taking warfarin or other coumarin-derivative anticoagulants. Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. Interstitial Lung Disease (ILD) Cases of serious ILD, including fatal cases, can occur with Erlotinib tablets treatment. The overall incidence of ILD in approximately 32,000 Erlotinib tablets-treated patients in uncontrolled studies and studies with concurrent chemotherapy was approximately 1.1%. In patients with ILD, the onset of symptoms was between 5 days to more than 9 months (median 39 days) after initiating Erlotinib tablets therapy. Withhold Erlotinib tablets for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation. If ILD is confirmed, permanently discontinue Erlotinib tablets. Renal failure Hepatorenal syndrome, severe acute renal failure including fatal cases, and renal insufficiency can occur with Erlotinib tablet treatment. Renal failure may arise from exacerbation of underlying baseline hepatic impairment or severe dehydration. The pooled incidence of severe renal impairment in the 3 monotherapy lung cancer studies was 0.5% in the Erlotinib tablets arms and 0.8% in the control arms. The incidence of renal impairment in the pancreatic cancer study was 1.4% in the Erlotinib tablet plus gemcitabine arm and 0.4% in the control arm. Withhold Erlotinib tablet in patients developing severe renal impairment until renal toxicity is resolved. Abridged from the full prescribing information.

---

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 serious adverse reactions, which may include fatalities, are discussed in greater detail in other sections of the labeling: Interstitial Lung Disease (ILD) Renal Failure Hepatotoxicity with or without Hepatic Impairment Gastrointestinal Perforation Bullous and Exfoliative Skin Disorders Cerebrovascular Accident Microangiopathic Hemolytic Anemia with Thrombocytopenia Ocular Disorders Hemorrhage in Patients Taking Warfarin The most common adverse reactions (≥20%) with Erlotinib tablets from a pooled analysis in patients with NSCLC across all approved lines of therapy, with and without EGFR mutations, and in patients with pancreatic cancer were rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, and vomiting. Clinical Trials Safety 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. Safety evaluation of Erlotinib tablet is based on more than 1200 cancer patients who received Erlotinib tablet as monotherapy, more than 300 patients who received Erlotinib tablet 100 or 150 mg plus gemcitabine, and 1228 patients who received Erlotinib tablet concurrently with other chemotherapies. The most common adverse reactions with Erlotinib tablet are rash and diarrhea usually with onset during the first month of treatment. The incidences of rash and diarrhea from clinical studies of Erlotinib tablet for the treatment of NSCLC and pancreatic cancer were 70% for rash and 42% for diarrhea. Non-Small Cell Lung Cancer First-Line Treatment of Patients with EGFR Mutations The most frequent (≥ 30%) adverse reactions in Erlotinib tablets-treated patients were diarrhea, asthenia, rash, cough, dyspnea, and decreased appetite. In Erlotinib tablets-treated patients the median time to onset of rash was 15 days and the median time to onset of diarrhea was 32 days. The most frequent Grade 3-4 adverse reactions in Erlotinib tablets-treated patients were rash and diarrhea. Dose interruptions or reductions due to adverse reactions occurred in 37% of Erlotinib tabletstreated patients, and 14.3% of Erlotinib tablets-treated patients discontinued therapy due to adverse reactions. In Erlotinib tablets-treated patients, the most frequently reported adverse reactions leading to dose modification were rash (13%), diarrhea (10%), and asthenia (3.6%). Abridged from the full prescribing information.

---

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.