Frequently Asked Questions

What is Tarceva?

Tarceva is a pill taken by mouth once a day on an empty stomach to treat your cancer. Tarceva is used for patients with advanced non-small cell lung cancer (NSCLC) who have received at least 1 previous chemotherapy regimen. You may be a candidate for maintenance treatment with Tarceva if your tumor has not spread or grown during the initial treatment. You may be a candidate for second/third-line treatment if the tumor grew or cancer spread after receiving chemotherapy. Tarceva is not intended to be used with chemotherapy. Take Tarceva on an empty stomach at least 1 hour before or 2 hours after eating.

What is maintenance treatment?

Maintenance treatment is given to patients in hopes that the patient will maintain a stable condition. Tarceva can be prescribed as maintenance treatment for advanced NSCLC.

What are second/third-line treatments?

Second/third-line treatments are given when the previous treatment does not work or has stopped working. Tarceva can be prescribed as second/third-line treatment for advanced NSCLC.

How is Tarceva thought to work?

Tarceva is not a chemotherapy drug. The way Tarceva works to treat cancer is not fully known. Tarceva is called a targeted cancer treatment. A targeted treatment is a kind of therapy that affects certain signals needed for cancer cells to grow. It may also impact healthy cells. Tarceva may slow or block the activity of a specific protein called epidermal growth factor receptor 1 (HER1/EGFR). Cancer cells need this protein to grow and divide.

Do any other medications interfere with Tarceva?

Tarceva may also affect medications you are taking. It is important that you tell your healthcare provider (HCP) if you are taking any other medications or supplements, including vitamins and herbal products (such as St. John's wort or antacids). DO NOT start taking any new medicines or herbal supplements before talking with your HCP.

What are the serious adverse reactions associated with Tarceva?

Serious side effects of Tarceva, including death, may include:

• Lung problems
• Liver and/or kidney problems
• A hole developing in the lining of the stomach or intestines
• Serious skin conditions
• Eye irritation and damage to the cornea (let your doctor know about eye problems that get worse, including eye pain)
• Bleeding events when taking warfarin

Women should not become pregnant while on treatment with Tarceva. If you are already pregnant or become pregnant while taking Tarceva, you should talk with your healthcare provider (HCP) about the benefits and risks of continuing to take Tarceva. DO NOT breast-feed while receiving treatment with Tarceva.

Please let your HCP know if you experience any of the following:

• New or worsening skin rash
• Serious or ongoing diarrhea, nausea, loss of appetite, or vomiting
• New or worsening shortness of breath or cough
• Eye irritation

Tarceva is not right for everyone. Ask your HCP if once-daily Tarceva is right for you.

What are the most common side effects I may experience with Tarceva?

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 <1% of the population and severe diarrhea occurred in <1% of the population.

Does Tarceva really work?

Please see possible benefits of Tarceva and Indications and Important Safety Information for Tarceva.

How do I know if I am a candidate for Tarceva?

Tarceva may be prescribed as maintenance treatment or as second/third-line treatment for locally advanced or metastatic NSCLC. You may be a candidate for maintenance treatment with Tarceva if your tumor has not spread or grown during the initial treatment, or your disease remained stable during the initial treatment. You may be a candidate for second/third-line treatment if previous chemotherapy did not work or stopped working. Speak with your doctor about whether Tarceva is right for you.

When in my treatment regimen can Tarceva be used?

Tarceva is approved as maintenance and second/third-line treatment of advanced non-small cell lung cancer (NSCLC). This means that your doctor can prescribe Tarceva after 1 chemotherapy regimen, whether or not your chemotherapy was successful.

What can I do if I experience a rash when taking Tarceva?

A rash may appear on your skin within 1-2 weeks 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 side effect of Tarceva. If you get a rash, do not stop taking Tarceva unless your doctor instructs you to do so. Some patients taking Tarceva have developed serious skin conditions. Try using a mild soap to wash areas affected by the rash, moisturize the area with a mild lotion, and avoid sun exposure. You may use a thick, alcohol-free cream on dry areas of the body. Also, use a sunscreen of SPF 15 or higher, preferably containing zinc oxide or titanium dioxide. Call your doctor if you are concerned about the rash. Your doctor may prescribe medications to help the rash or dry skin. Please see Managing Most Common Tarceva Side Effects for more information. Also, it's important to take Tarceva on an empty stomach at least 1 hour before or 2 hours after eating. Taking Tarceva with food may increase your chance of developing side effects.

What signs or symptoms should I watch for?

Call your doctor right away if you have the following signs or symptoms:

• New or worsening skin rash
• Serious or ongoing diarrhea, nausea, loss of appetite, or vomiting
• New or worsening shortness of breath or cough
• Eye irritation

Let your doctor know if you are taking other prescription medications, over-the-counter drugs, or herbal supplements.

How do I take Tarceva?

Tarceva is a pill taken by mouth once a day without food as prescribed by your doctor. It's important to take Tarceva on an empty stomach at least 1 hour before or 2 hours after eating.

Take Tarceva at the same time each day between meals.

Where can I get Tarceva?

Your insurance plan may offer various options for coverage. Choose a pharmacy participating in your insurance or health plan to ensure your prescriptions are covered.

Learn more about filling your prescription

Where can I find insurance coverage information for Tarceva?

If you are unsure about your insurance coverage for Tarceva, Tarceva Access Solutions^® may be able to help. Tarceva Access Solutions provides coverage and reimbursement support, patient assistance, and other informational resources.

When you or your doctor's office calls Tarceva Access Solutions, you can speak with one of our dedicated Access Solutions Specialists, whose only job is to work with you to get the help you need to cover the cost of your medicine.

To learn more about how we can help you or a loved one, call 1 (888) 249-4918 and speak live with one of our Specialists or visit www.genentech-access.com/tarceva/patients.

How long has Tarceva been available for advanced NSCLC?

The Food and Drug Administration (FDA) approved Tarceva for second/third-line treatment of advanced non-small cell lung cancer (NSCLC) on November 18, 2004.

In April 2010, Tarceva was approved by the FDA as maintenance therapy for patients with advanced-stage NSCLC.

Are there Tarceva clinical trials available for patients with advanced NSCLC?

You can find information on clinical trials of Tarceva by visiting www.ClinicalTrials.gov.

Does smoking interfere with Tarceva?

Smoking may affect how well Tarceva works for you. If you smoke, you should stop smoking before starting treatment with Tarceva. Talk with your HCP about how to quit smoking. If you continue to smoke, you should talk to your HCP before taking Tarceva.

What Important Safety Information should I know about Tarceva?

See Important Safety Information for Tarceva below.