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TARCEVA (ERLOTINIB): WARNINGS AND PRECAUTIONS

Pulmonary Toxicity

There have been reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Tarceva tablets for treatment of NSCLC, pancreatic cancer or other advanced solid tumors. In the randomized single-agent NSCLC studies, the incidence of serious ILD-like events in the Erlotinib tablets treated patients versus placebo treated patients was 0.7% versus 0% in the maintenance study and 0.8% for both groups in the 2nd and 3rd line study. In the pancreatic cancer study - in combination with gemcitabine, the incidence of ILD-like events was 2.5% in the Tarceva plus gemcitabine group vs. 0.4% in the placebo plus gemcitabine group.

The overall incidence of ILD-like events in approximately 32,000 Tarceva-treated patients from all studies (including uncontrolled studies and studies with concurrent chemotherapy) was approximately 1.1%.

Reported diagnoses in patients suspected of having ILD-like events included radiation pneumonitis, pneumonitis, hypersensitivity pneumonitis, interstitial lung disease, interstitial pneumonia, obliterative bronchiolitis, pulmonary fibrosis, Acute Respiratory Distress Syndrome and lung infiltration. Symptoms started from 5 days to more than 9 months (median 39 days) after initiating Erlotinib therapy. In the lung cancer trials most of the cases were associated with confounding or contributing factors such as concomitant / prior chemotherapy, pre-existing parenchymal lung disease, prior radiotherapy, metastatic lung disease, or pulmonary infections.

In the event of an acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever, Tarceva (Erlotinib) therapy should be interrupted pending diagnostic evaluation. If ILD is diagnosed, Erlotinib (Tarceva) should be discontinued and appropriate treatment instituted as needed.

Renal Failure

Cases of hepatorenal syndrome, acute renal failure (including fatalities), and renal insufficiency have been reported. Some were secondary to baseline hepatic impairment while others were associated with severe dehydration due to diarrhea, vomiting, and/or anorexia or concurrent chemotherapy use. In the event of dehydration, particularly in patients with contributing risk factors for renal failure (eg, pre-existing renal disease, medical conditions or medications that may lead to renal disease, or other predisposing conditions including advanced age), Tarceva (Erlotinib Hydrochloride) therapy should be interrupted and appropriate measures should be taken to intensively rehydrate the patient. Periodic monitoring of renal function and serum electrolytes is recommended in patients at risk of dehydration.

Hepatotoxicity

Cases of hepatic failure and hepatorenal syndrome (including fatalities) have been reported during use of Erlotinib Hydrochloride (Tarceva), particularly in patients with baseline hepatic impairment. Therefore, periodic liver function testing (transaminases, bilirubin, and alkaline phosphatase) is recommended. In the setting of worsening liver function tests, dose interruption and/or dose reduction with frequent liver function test monitoring should be considered. Tarceva (Erlotinib HCl) dosing should be interrupted or discontinued if total bilirubin is >3 x ULN and/or transaminases are >5 x ULN in the setting of normal pretreatment values.

Patients with Hepatic Impairment

In a pharmacokinetic study in patients with moderate hepatic impairment (Child-Pugh B) associated with significant liver tumor burden, 10 out of 15 patients died on treatment or within 30 days of the last Erlotinib HCl (Tarceva) dose. One patient died from hepatorenal syndrome, 1 patient died from rapidly progressing liver failure and the remaining 8 patients died from progressive disease. Six out of the 10 patients who died had baseline total bilirubin > 3 x ULN suggesting severe hepatic impairment. Treatment with Tarceva (Erlotinib HCl) tablets should be used with extra caution in patients with total bilirubin > 3 x ULN. Patients with hepatic impairment (total bilirubin > ULN or Child-Pugh A, B and C) should be closely monitored during therapy with Erlotinib HCl (Tarceva) tablets. This drug dosing should be interrupted or discontinued if changes in liver function are severe such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside normal range.

Gastrointestinal Perforation

Gastrointestinal perforation (including fatalities) have been reported in patients receiving Tarceva tablets. Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease are at increased risk. Permanently discontinue Erlotinib tablets in patients who develop gastrointestinal perforation.

Bullous and Exfoliative Skin Disorders

Bullous, blistering and exfoliative skin conditions have been reported including cases suggestive of Stevens-Johnson syndrome / Toxic epidermal necrolysis, which in some cases were fatal. Interrupt or discontinue Tarceva treatment if the patient develops severe bullous, blistering or exfoliating conditions.

Myocardial Infarction / Ischemia

In the pancreatic carcinoma trial, six patients (incidence of 2.3%) in the Tarceva / Gemcitabine group developed myocardial infarction / ischemia. One of these patients died due to myocardial infarction. In comparison, 3 patients in the placebo / gemcitabine group developed myocardial infarction (incidence 1.2%) and one died due to myocardial infarction.

Cerebrovascular Accident

In the pancreatic carcinoma trial, six patients in the Tarceva / Gemcitabine group developed cerebrovascular accidents (incidence: 2.3%). One of these was hemorrhagic and was the only fatal event. In comparison, in the placebo / gemcitabine group there were no cerebrovascular accidents.

Microangiopathic Hemolytic Anemia with Thrombocytopenia

In the pancreatic carcinoma trial, two patients in the Tarceva / Gemcitabine group developed microangiopathic hemolytic anemia with thrombocytopenia (incidence: 0.8%). Both patients received Tarceva and gemcitabine concurrently. In comparison, in the placebo/gemcitabine group there were no cases of microangiopathic hemolytic anemia with thrombocytopenia.

Ocular Disorders

Corneal perforation or ulceration have been reported during use of Erlotinib. Other ocular disorders including abnormal eyelash growth, keratoconjunctivitis sicca or keratitis have been observed with Tarceva (Erlotinib) treatment and are known risk factors for corneal ulceration / perforation. Interrupt or discontinue Erlotinib (Tarceva) therapy if patients present with acute/worsening ocular disorders such as eye pain.

Elevated International Normalized Ratio and Potential Bleeding

International Normalized Ratio (INR) elevations and infrequent reports of bleeding events, including gastrointestinal and non-gastrointestinal bleeding, have been reported in clinical studies, some associated with concomitant warfarin administration. Patients taking warfarin or other coumarin-derivative anticoagulants should be monitored regularly for changes in prothrombin time or INR.

Use in Pregnancy

Tarceva (Erlotinib Hydrochloride) can cause fetal harm when administered to a pregnant woman. Erlotinib administered to rabbits during organogenesis at doses that result in plasma drug concentrations of approximately 3 times those in humans at the recommended dose of 150 mg daily, was associated with embryofetal lethality and abortion. When erlotinib was administered to female rats prior to mating and through the first week of pregnancy, at doses 0.3 or 0.7 times the clinical dose of 150 mg, on a mg/m2 basis, there was an increase in early resorptions that resulted in a decrease in the number of live fetuses.

There are no adequate and well-controlled studies in pregnant women using Erlotinib Hydrochloride (Tarceva). Women of childbearing potential should be advised to avoid pregnancy while on Tarceva (Erlotinib HCl). Adequate contraceptive methods should be used during therapy, and for at least 2 weeks after completing therapy. If Erlotinib HCl (Tarceva) is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

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