Frequently Asked Questions

What is Tarceva?

Tarceva (erlotinib) is a pill taken by mouth once a day on an empty stomach to treat your cancer. Tarceva is used for patients with advanced NSCLC who have received at least one 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- or third-line treatment if previous chemotherapy did not work. Tarceva is not intended to be used with chemotherapy. Take Tarceva on an empty stomach at least one hour before or two 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. That means that Tarceva has been proven to be effective in helping some patients maintain results from previous and successful chemotherapy treatment.

What are second- and third-line treatments?

Second- and third-line treatments are given when the previous treatment does not work or has stopped working. Tarceva can be prescribed as second- or third-line treatment for advanced NSCLC. That means that Tarceva has been proven to be effective in helping some patients whose first or second line of treatment (chemotherapy) was not successful.

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 because it slows or blocks the activity of a specific protein called epidermal growth factor receptor (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 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 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?

Though individual results may vary, Tarceva has been shown to help some patients live longer.

Maintenance treatment with Tarceva has been shown to extend overall survival time and increase the time until the cancer gets worse. In a large study in people with advanced NSCLC who received Tarceva as a maintenance treatment, patients who took Tarceva had a median* overall survival time of 12 months versus patients who took a placebo (sugar pill) had a median* overall survival of time of 11 months. 29% of patients (about 1 in 3 patients) who took Tarceva had a reduction in the risk of their cancer getting worse or of death.

As a second/third-line treatment, Tarceva has been shown to help some patients live longer. In a large study in people with advanced NSCLC who have not taken Tarceva before and whose cancer has grown or spread after at least 1 prior chemotherapy regimen: 31% (about 1 in 3 patients) who took Tarceva was still living one year later versus 22% (about 1 in 5 patients) who took a placebo (sugar pill) was still living 1 year later. Patients who took Tarceva had a median overall survival time of 6.7 months versus patients who took placebo (sugar pill) who had a median overall survival time of 4.7 months.

*Median is the midpoint of a range of numbers. This means that half the patients had a shorter overall survival time and half had a longer overall survival time.

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

Tarceva may be prescribed as maintenance treatment or as second or 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- or third-line treatment if previous chemotherapy did not work. 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- and third-line treatment. This means that your doctor can prescribe Tarceva after one 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 Tarceva Side Effects for more information. Also, it's important to take Tarceva on an empty stomach at least one hour before or two 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 one hour before or two hours after eating. Taking Tarceva with food may increase your chance of developing side effects.

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 call Tarceva Access Solutions, you can speak with one of our dedicated 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 (800) 249-4918 and speak live with one of our specialists or visit AccessSolutions.com.

How long has Tarceva been available for 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.

For more information, see the FDA Approval Letter.

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

You can find information on clinical trials of Tarceva (erlotinib) by visiting 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 Tarceva safety information below.