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Tarceva® erlotinib tablets

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 that did not work. Take Tarceva at least one hour before or two hours after eating.

Q. How does Tarceva work?

A. 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 are Tarceva's benefits?

A. 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.

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

A. 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.

Q. Does Tarceva really work?

A. Though individual results may vary, Tarceva has been shown to help some patients live longer. In a large clinical study, 31.2% of patients who were taking Tarceva were alive one year after they started Tarceva, as compared with 21.5% of patients who took a sugar pill. Additionally, large clinical studies have also proven that Tarceva can slow or stop the growth of cancer cells in some patients. Speak with your doctor about whether Tarceva is right for you.

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

A. 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.

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

A. 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.

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

No FoodA. 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. 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 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 information should I know about Tarceva?

A. 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. Please see Important Safety Information for additional rare, but possibly serious side effects.

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 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

Indication and Usage for Lung Cancer Patients

Tarceva is prescribed for patients with advanced-stage non-small cell lung cancer (NSCLC) who have received at least one prior chemotherapy regimen.

Important Safety Information

In clinical studies, there were infrequent reports of lung injuries similar to Interstitial Lung Disease (ILD)-like events in patients taking Tarceva for the treatment of non-small cell lung cancer (NSCLC) or other advanced solid tumors. Reports of these ILD-like lung injuries have been serious and have included deaths in some patients.

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

Holes that formed in the stomach, small intestine, or large bowel (including deaths) have been reported in patients taking Tarceva.

Severe blistering skin reactions including cases similar to Stevens-Johnson syndrome (including deaths) have been reported in patients taking Tarceva.

Eye irritation and damage to the cornea have been reported in patients taking Tarceva. Patients should tell their doctor about eye problems, including eye pain, that get worse.

Tarceva may cause harm to an unborn baby or may cause possible risk of pregnancy loss. Women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva.

Call your doctor 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

If you smoke, you should stop smoking while taking Tarceva, as it may affect how well Tarceva works for you. If you continue to smoke you should speak to your doctor before taking Tarceva.

Let your doctor know if you are taking other prescription or over-the-counter drugs or herbal supplements before you start taking Tarceva. While taking Tarceva, do not start taking any new drugs or herbal supplements before talking to your doctor. Do not eat grapefruit or drink grapefruit juice while taking Tarceva. Tarceva may also affect other medications you are taking.

Common side effects of Tarceva

Rash and diarrhea were the most common side effects associated with Tarceva in a large clinical study. They were usually mild to moderate. You may also have other changes in your skin.

Always let your doctor or nurse know if you experience any side effects. Ask your doctor or nurse for the best way to handle drug-related side effects.

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


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Tarceva® erlotinib tablets