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TARCEVA (ERLOTINIB): ADVERSE REACTIONS / SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reactions 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 Tarceva (Erlotinib HCl) tablets is based on more than 1200 cancer patients who received this medicine as monotherapy, more than 300 patients who received Erlotinib HCl (Tarceva) tablets 100 or 150 mg plus gemcitabine, and 1228 patients who received Tarceva tablets concurrently with other chemotherapies.

There have been reports of serious events, including fatalities, in patients receiving Erlotinib tablets for treatment of NSCLC, pancreatic cancer or other advanced solid tumors.

Clinical Trial Experience

Non-Small Cell Lung Cancer

Maintenance Study

Adverse reactions, regardless of causality, that occurred in at least 3% of patients treated with single-agent Tarceva at 150 mg and at least 3% more often than in the placebo group in the randomized maintenance trial are summarized by NCI-CTC (version 3.0): rash, diarrhea, fatigue, anorexia, pruritus, acne, dermatitis acneiform, dry skin, weight loss, paronychia.

The most common adverse reactions in patients receiving single-agent Erlotinib 150 mg were rash and diarrhea. Grade 3/4 rash and diarrhea occurred in 6.0% and 1.8%, respectively, in Tarceva-treated patients. Rash and diarrhea resulted in study discontinuation in 1.2% and 0.5% of Tarceva-treated patients, respectively. Dose reduction or interruption for rash and diarrhea was needed in 5.1% and 2.8% of patients, respectively. In Tarceva-treated patients who developed rash, the onset was within two weeks in 66% and within one month in 81%.

Liver function test abnormalities (including elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) were observed in patients receiving single-agent Tarceva (Erlotinib) 150 mg in the Maintenance study. Grade 2 ( > 2.5 - 5.0 x ULN) ALT elevations occurred in 2% and 1%, and Grade 3 ( > 5.0 - 20.0 x ULN) ALT elevations were observed in 1% and 0% of Erlotinib (Tarceva) and placebo treated patients, respectively. The Tarceva (Erlotinib Hydrochloride) treatment group had Grade 2 ( > 1.5-3.0 x ULN) bilirubin elevations in 4% and Grade 3 ( > 3.0 - 10.0 x ULN) in < 1% compared with < 1% for both Grades 2 and 3 in the placebo group. Erlotinib Hydrochloride (Tarceva) dosing should be interrupted or discontinued if changes in liver function are severe.

Second / Third Line Study

Adverse reactions, regardless of causality, that occurred in at least 10% of patients treated with single-agent Tarceva (Erlotinib HCl) at 150 mg and at least 3% more often than in the placebo group in the randomized trial of patients with NSCLC are summarized by NCI-CTC (version 2.0): diarrhea, rash, anorexia, dyspnea, fatigue, cough, infection, nausea, vomiting, pruritus, stomatitis, dry skin, keratoconjunctivitis sicca, conjunctivitis, abdominal pain.

The most common adverse reactions in this patient population were rash and diarrhea. Grade 3/4 rash and diarrhea occurred in 9% and 6%, respectively, in Tarceva-treated patients. Rash and diarrhea each resulted in study discontinuation in 1% of Tarceva-treated patients. Six percent and 1% of patients needed dose reduction for rash and diarrhea, respectively. The median time to onset of rash was 8 days, and the median time to onset of diarrhea was 12 days.

Liver function test abnormalities (including elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) were observed in patients receiving single-agent Erlotinib HCl (Tarceva) 150 mg. These elevations were mainly transient or associated with liver metastases. Grade 2 ( > 2.5 - 5.0 x ULN) ALT elevations occurred in 4% and < 1% of Tarceva (Erlotinib HCl) tablets and placebo treated patients, respectively. Grade 3 ( > 5.0 - 20.0 x ULN) elevations were not observed in Tarceva-treated patients. Erlotinib HCl (Tarceva) tablets dosing should be interrupted or discontinued if changes in liver function are severe.

Pancreatic Cancer

Adverse reactions, regardless of causality, that occurred in at least 10% of patients treated with Tarceva tablets 100 mg plus gemcitabine in the randomized trial of patients with pancreatic cancer are summarized by NCI-CTC (version 2.0): fatigue, rash, nausea, anorexia, diarrhea, abdominal pain, vomiting, weight decreased, infection, edema, pyrexia, constipation, bone pain, dyspnea, stomatitis, myalgia, depression, dyspepsia, cough, dizziness, headache, insomnia, alopecia, anxiety, neuropathy, flatulence, rigors.

The most common adverse reactions in pancreatic cancer patients receiving Erlotinib tablets 100 mg plus gemcitabine were fatigue, rash, nausea, anorexia and diarrhea. In the Tarceva plus Gemcitabine arm, Grade 3/4 rash and diarrhea were each reported in 5% of Erlotinib plus Gemcitabine-treated patients.

The median time to onset of rash and diarrhea was 10 days and 15 days, respectively. Rash and diarrhea each resulted in dose reductions in 2% of patients, and resulted in study discontinuation in up to 1% of patients receiving Tarceva (Erlotinib) plus Gemcitabine. The 150 mg cohort was associated with a higher rate of certain class-specific adverse reactions including rash and required more frequent dose reduction or interruption.

In the pancreatic carcinoma trial, 10 patients in the Tarceva / Gemcitabine group developed deep venous thrombosis (incidence: 3.9%). In comparison, 3 patients in the placebo / gemcitabine group developed deep venous thrombosis (incidence 1.2%). The overall incidence of grade 3 or 4 thrombotic events, including deep venous thrombosis, was similar in the two treatment arms: 11% for Erlotinib (Tarceva) plus gemcitabine and 9% for placebo plus gemcitabine.

No differences in Grade 3 or Grade 4 hematologic laboratory toxicities were detected between the Tarceva (Erlotinib Hydrochloride) plus gemcitabine group compared to the placebo plus gemcitabine group.

Severe adverse reactions ( >= grade 3 NCI-CTC) in the Erlotinib Hydrochloride (Tarceva) plus gemcitabine group with incidences < 5% included arrhythmias, syncope, ileus, pancreatitis, hemolytic anemia including microangiopathic hemolytic anemia with thrombocytopenia, myocardial infarction / ischemia, cerebrovascular accidents including cerebral hemorrhage, and renal insufficiency.

Liver function test abnormalities (including elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) have been observed following the administration of Tarceva (Erlotinib HCl) plus gemcitabine in patients with pancreatic cancer.

Erlotinib HCl (Tarceva) dosing should be interrupted or discontinued if changes in liver function are severe.

NSCLC and Pancreatic Indications: Low Frequency Adverse Reactions

Gastrointestinal Disorders

Gastrointestinal perforations have been reported.

During the NSCLC and the combination pancreatic cancer trials, infrequent cases of gastrointestinal bleeding have been reported, some associated with concomitant warfarin or NSAID administration. These adverse reactions were reported as peptic ulcer bleeding (gastritis, gastroduodenal ulcers), hematochezia, hematemesis, melena and hemorrhage from possible colitis.

Renal Disorders

Cases of acute renal failure or renal insufficiency, including fatalities, with or without hypokalemia have been reported.

Hepatic Disorders

Hepatic failure has been reported in patients treated with single-agent Tarceva (Erlotinib HCl) tablets or this medicine combined with chemotherapy.

Ocular Disorders

Corneal ulcerations or perforations have been reported in patients receiving Erlotinib HCl (Tarceva) tablets treatment. Abnormal eyelash growth including in-growing eyelashes, excessive growth and thickening of the eyelashes have been reported and are risk factors for corneal ulceration / perforation.

NCI-CTC Grade 3 conjunctivitis and keratitis have been reported infrequently in patients receiving Tarceva tablets therapy in the NSCLC and pancreatic cancer clinical trials.

Skin, Hair, and Nail Disorders

Bullous, blistering and exfoliative skin conditions have been reported including cases suggestive of Stevens-Johnson syndrome / Toxic epidermal necrolysis.

In patients who develop skin rash, the appearance of the rash is typically erythematous and maculopapular and it may resemble acne with follicular pustules, but is histopathologically different. This skin reaction commonly occurs on the face, upper chest and back, but may be more generalized or severe (NCI-CTC Grade 3 or 4) with desquamation. Skin reactions may occur or worsen in sun exposed areas; therefore, the use of sunscreen or avoidance of sun exposure is recommended. Associated symptoms may include itching, tenderness and/or burning. Also, hyperpigmentation or dry skin with or without digital skin fissures may occur.

Hair and nail disorders including hirsutism, alopecia, eyelash / eyebrow (see above) changes, paronychia and brittle and loose nails have been reported.

Other Disorders

Epistaxis was also reported in both the single-agent NSCLC and the pancreatic cancer clinical trials.

In general, no notable differences in the safety of Erlotinib tablets monotherapy or in combination with gemcitabine could be discerned between females or males and between patients younger or older than the age of 65 years. The safety of Tarceva appears similar in Caucasian and Asian patients.

Post-marketing Experience

The following adverse reactions have been identified during post approval use of Erlotinib. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and subcutaneous tissue disorders

Hair and nail changes, mostly non-serious e.g. hirsutism, eyelash / eyebrow changes, paronychia and brittle and loose nails. Bullous, blistering and exfoliative skin conditions have been reported including cases suggested of Stevens-Johnson syndrome / Toxic epidermal necrolysis.

Gastrointestinal Disorders

Gastrointestinal perforations.

Hepatic Disorders

Hepatic failure has been reported in patients treated with single-agent Tarceva (Erlotinib) or this medication combined with chemotherapy.

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