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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 in combination with gemcitabine is prescribed for patients who have not received previous chemotherapy for locally advanced pancreatic cancer, pancreatic cancer that cannot be surgically removed or that has spread to distant body organs.

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 pancreatic cancer.

Q. What are Tarceva's benefits?

A. Tarceva is an FDA-approved targeted cancer therapy clinically proven to help some pancreatic cancer patients live 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. Fatigue, rash, nausea, loss of appetite and diarrhea were the most common side effects associated with the Tarceva plus gemcitabine therapy in a large clinical study. Severe rash and diarrhea were each reported in 5% of patients receiving Tarceva plus gemcitabine therapy in this same large clinical study.

The rash associated with the Tarceva plus gemcitabine therapy may appear on your body or face, typically within 8-10 days of starting this treatment. However, the rash may occur anytime during this treatment. The rash associated with Tarceva is not an allergic reaction and may look like acne or dry skin, but it is not acne. Avoid acne-related treatments, including products with benzoyl peroxide. Please contact your doctor if you develop a rash.

Typically, diarrhea may develop within 15 days of starting the Tarceva plus gemcitabine therapy. Let your doctor or nurse know if you experience side effects.

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, 23.8% of patients taking Tarceva (100mg) plus gemcitabine were living with their pancreatic cancer one year after they started this treatment, compared with 19.4% of patients receiving gemcitabine alone. That's a 22.7% increase (approximately 23%) in one-year survival for patients on Tarceva plus gemcitabine therapy. How well Tarceva plus gemcitabine therapy works for you may differ from these results. Please 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 pancreatic cancer that cannot be surgically removed or that has spread to distant body organs, 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 in combination with gemcitabine for first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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 plus gemcitabine therapy, most likely on your upper body or face. The rash associated with Tarceva is not an allergic reaction and 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 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. Patients receiving Tarceva plus gemcitabine were more likely to experience bleeding and clotting problems, such as heart attack or stroke. 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 pancreatic cancer.

Q. How long has Tarceva been available for advanced pancreatic cancer?

A. The Food and Drug Administration (FDA) approved Tarceva for advanced pancreatic cancer on November 2, 2005.

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

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

Indication and Usage for Pancreatic Cancer Patients

Tarceva in combination with gemcitabine is prescribed for patients with advanced-stage pancreatic cancer who have not received previous chemotherapy.

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 pancreatic cancer 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.

Patients taking Tarceva plus gemcitabine were more likely to experience bleeding and clotting problems such as heart attack or stroke.

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

Fatigue, rash, nausea, loss of appetite, and diarrhea were the most common side effects associated with Tarceva plus gemcitabine therapy in a large clinical study.

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