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Tarceva® erlotinib tablets
An advancement in 2nd line NSCLC treatment. Tarceva monotherapy is indicated for the treatment of patients with locally
			advanced or metastatic non-small cell lung cancer.

Frequently Asked Questions

Q. What is Tarceva?

A. Tarceva (erlotinib) 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. 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-line treatment if previous chemotherapy did not work. Take Tarceva on an empty stomach, at least one hour before or two hours after eating.

Indications and Usage for Advanced Non-Small Cell Lung Cancer Patients

Tarceva is prescribed for patients with advanced-stage non-small cell lung cancer (NSCLC) whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance treatment).

Tarceva is prescribed for patients with advanced-stage non-small cell lung cancer (NSCLC) whose cancer has spread or grown after receiving at least 1 chemotherapy regimen (second/third-line treatment).

Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.

Q. How does Tarceva work?

A. How Tarceva works is not fully known. 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.

Q. What common side effects may I experience with Tarceva?

A. Rash and diarrhea were the most common side effects associated with Tarceva in NSCLC. 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.

Q. 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 patient) 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 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) had a median overall survival time of 4.7 months.

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

A. 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. Speak with your doctor about whether Tarceva is right for you. Tarceva is not meant to be used at the same time as chemotherapy.

Q. When in my treatment regimen can Tarceva be used?

A. Tarceva is approved as maintenance, second, and third-line treatment. This means that your doctor can prescribe Tarceva after one chemotherapy regimen, whether or not your chemotherapy was successful. Tarceva is not meant to be used at the same time as chemotherapy.

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

No FoodA. A rash may appear on your skin within 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 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. You may use a thick, alcohol-free cream on dry areas of the body. Also, use a sunscreen of SPF15 or higher, preferably containing zinc oxide or titanium dioxide. Call your doctor if you are concerned about the rash. Your doctor may prescribe drugs 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.

Q. What other important safety information should I know about Tarceva?

A. In clinical trials of Tarceva and NSCLC, there were some reports of serious adverse events including lung problems; liver and/or kidney problems; a hole developing in the lining of the stomach or intestines; serious skin conditions; bleeding and clotting problems such as heart attack or stroke (for patients taking Tarceva plus gemcitabine); and eye irritation and damage to the cornea (let your doctor know about eye problems that get worse including eye pain). Women should not become pregnant while on treatment with Tarceva. DO NOT breast-feed while receiving treatment with Tarceva.

Q. What signs or symptoms should I watch for?

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

  • Severe or persistent diarrhea, nausea, loss of appetite or vomiting
  • Onset or worsening of unexplained shortness of breath or cough
  • Eye irritation
  • Rash or other changes in your skin

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

Q. How do I take Tarceva?

No FoodA. 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.

Q. Where can I get Tarceva?

A. 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.

Q. Where can I find insurance coverage information for Tarceva?

A. 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.

Q. How long has Tarceva been available for NSCLC?

A. 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.

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

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

Q. What is maintenance treatment?

A. Maintenance treatment is given to patients to help maintain a stable condition. Tarceva can be prescribed as maintenance treatment for advanced NSCLC. Tarceva has been proven in the clinical trials to be effective in helping some patients maintain results from previous successful chemotherapy treatment.

Q. What is second/third-line treatment?

A. Second/third-line treatment is given when previous treatments do not work or have stopped working. Tarceva can be prescribed as second/third-line treatment for advanced NSCLC.

Indications and Usage for Advanced Non-Small Cell Lung Cancer Patients

Tarceva is prescribed for patients with advanced-stage non-small cell lung cancer (NSCLC) whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance treatment).

Tarceva is prescribed for patients with advanced-stage non-small cell lung cancer (NSCLC) whose cancer has spread or grown after receiving at least 1 chemotherapy regimen (second/third-line treatment).

Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.

Important Safety Information

Possible effects on the lungs

There have been reports of serious adverse events involving the lungs in a small number of patients taking Tarceva. These events have included death in some patients. The medical name for these types of events is interstitial (in-tur STISH-ul) lung disease-like events (or ILD-like events).

Possible effects on the kidneys and liver

Liver and/or kidney problems (including deaths) have been reported in some patients taking Tarceva. Let your healthcare provider (HCP) know if you have a history of liver or kidney disease.

Possible effects on the stomach and intestines

Some patients taking Tarceva have developed a hole in the lining of their stomach or intestines (including deaths).

Possible effects on the skin

Some patients taking Tarceva have developed serious skin conditions. Some patients have died from these conditions.

Possible effects on the eye

Some patients taking Tarceva have developed eye irritation and damage to the cornea. Patients should tell their HCP about eye problems that get worse, including eye pain.

Tarceva and pregnancy and breast-feeding

Women should not become pregnant while on treatment with Tarceva. DO NOT breast-feed while receiving treatment with Tarceva.

When to call your HCP

Call your HCP right away if you have these signs or symptoms:

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

Before you start taking Tarceva

Some patients taking Tarceva have experienced difficulty with blood clotting, and bleeding events, including gastrointestinal and non-gastrointestinal bleeding. Patients taking blood thinners (Coumadin®, warfarin or other coumarin-derivatives) should be monitored regularly.

Taking other medicines and herbal supplements with Tarceva

It is important that you tell your HCP about all of the medicines and herbal supplements you are taking. DO NOT start taking any new medicines or herbal supplements before talking with your HCP. Tarceva may also affect other medications you are taking.

DO NOT eat grapefruit or drink grapefruit juice while on treatment with Tarceva, except under the care of your HCP.

Smoking

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.

Common side effects of Tarceva

The most common side effects in patients who took Tarceva were mild to moderate rash and diarrhea. You may also have other changes in your skin.

Hair and nail changes have been seen with Tarceva.

Always let your HCP know if you have any side effects, and ask about the best way to handle them.

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


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Tarceva® erlotinib tablets