Tarceva is a pill taken by mouth once a day to treat your cancer. Tarceva is used for patients with advanced NSCLC who have received at least one previous chemotherapy regimen that did not work. Take Tarceva at least one hour before or two hours after eating.

Tarceva is an FDA-approved targeted cancer therapy clinically proven to help some NSCLC patients live significantly longer. In addition to improving survival, Tarceva may slow or stop the growth of cancer - and may even shrink the tumors in some patients. Tarceva is convenient to take; it's a pill you take by mouth once a day as prescribed by your doctor. Individual results may vary. Though individual results may vary, Tarceva has been shown to help some patients live longer.

Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Results from two multicenter, placebo-controlled, randomized, Phase III trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy, and its use is not recommended in that setting.

Since food substantially increases the bioavailability of erlotinib and may increase the risk of adverse events, patients should be instructed to take Tarceva at least one hour before or two hours after the ingestion of food. The degree that food increases the bioavailability of erlotinib may vary; therefore, Tarceva tablets should be taken on an empty stomach to help ensure that patients obtain consistent plasma levels of the drug.

Tarceva is a targeted cancer treatment. Unlike many traditional chemotherapies, Tarceva affects certain cancer cell activities. Tarceva is designed to block tumor cell growth by targeting the protein in your body called the Human Epidermal Growth Factor Receptor 1 (HER1/EGFR). This protein is important for tumor cell growth in NSCLC.

If you have locally advanced or metastatic NSCLC and have received at least one chemotherapy regimen that has not worked, you may be a candidate for Tarceva. Speak with your doctor about whether Tarceva is right for you.

Tarceva is approved as monotherapy, meaning it is used without chemotherapy, for second- and third-line treatment of advanced NSCLC patients. This means that your doctor can prescribe Tarceva after one chemotherapy regimen has not worked.

Rash and diarrhea were the most common side effects associated with Tarceva. They were generally mild to moderate. In large clinical studies, severe rash occurred in 9% of patients and severe diarrhea occurred in 6% of patients. You may also have other changes in your skin.

A rash may appear on your skin within 8-10 days of starting Tarceva therapy, most likely on your upper body or head. It may look like acne or dry skin, but it is not acne. Avoid acne-related treatments, including products with benzoyl peroxide. Rash is a common reaction to Tarceva. If you get a rash, do not stop taking Tarceva unless your doctor instructs you to do so. Try using a mild soap to wash areas affected by the rash, moisturize the area with a mild lotion and avoid sun exposure.

All drugs have the possibility of causing some side effects. Some rare, but possibly serious, side effects may occur with Tarceva. In large clinical studies, there were infrequent reports of a lung injury known as Interstitial Lung Disease (ILD) and have included fatalities. Tarceva may cause liver problems. Let your doctor know if you have a history of liver disease. Women should also avoid becoming pregnant or breastfeeding while taking Tarceva.

Patients will need to speak with their insurance provider to determine if Tarceva is covered. Each provider will respond differently. However, Medicare supplemental drug plans do provide coverage for Tarceva for advanced non-small cell lung cancer.

The Food and Drug Administration (FDA) approved Tarceva for advanced Non-Small Cell Lung Cancer on November 18, 2004. For more information see the FDA Approval Letter.

The potent CYP3A4 inhibitor ketoconazole has been shown to increase erlotinib AUC; thus, caution should be used during co-treatment with Tarceva and ketoconazole or other CYP3A4 inhibitors such as, but not limited to: atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO) and voriconazole.

Tarceva has no known contraindications, and its safety profile has been established in more than 2,000 patients in completed clinical trials. In the single-agent NSCLC Phase III trial, the most common side effects-rash and diarrhea-were generally mild to moderate. Each resulted in treatment discontinuation in 1% of Tarceva-treated patients.

There have been infrequent reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Tarceva. The overall incidence of ILD-like events in Tarceva-treated patients from all studies was approximately 0.7%. In NSCLC, single-agent Phase III study incidence was 0.8%-the same as placebo. In pancreatic cancer, in combination with gemcitabine study incidence was 2.5% in the Tarceva plus gemcitabine arm vs 0.4% in the placebo plus gemcitabine arm.

Tarceva is indicated for the treatment of patients with locally advanced or metastatic Non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. In the pivotal clinical trial for NSCLC, there was a significant survival benefit for a large, unselected group of patients receiving Tarceva monotherapy. Tarceva significantly improved overall survival by 37% vs placebo in these pretreated NSCLC patients (HR=0.73; 95% CI=0.61-0.86; P<0.001).

Tarceva Access Solutions provides coverage and reimbursement support, patient assistance and informational resources for both health care providers and their patients. You can access Tarceva Access Solutions on the Internet at www.TarcevaAccessSolutions.com or call the toll-free support line at 1-888-249-4918. If uninsured or financially challenged patients need help covering the cost of Tarceva, the experts at Genentech Access Solutions can help them with this issue.

You can find information on additional clinical trials of Tarceva (erlotinib) by visiting ClinicalTrials.gov