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Tarceva for advanced-stage pancreatic cancer

Tarceva for advanced pancreatic cancer:

  • Tarceva in combination with gemcitabine is prescribed for patients with advanced-stage pancreatic cancer whose cancer has spread, grown, or cannot be surgically removed and who have not received previous chemotherapy.

In a large study of 521 patients with advanced pancreatic cancer:

Tarceva versus Placebo Survival Time for Advanced Pancreatic Cancer

  • Patients who took Tarceva plus gemcitabine had a 19% lower risk of death than those who took a placebo plus gemcitabine.
  • The patients who took Tarceva plus gemcitabine had a median* progression-free survival of 3.8 months compared with 3.5 months for those who took a placebo plus gemcitabine.
  • The tumors of 8.6% of patients who took Tarceva plus gemcitabine got smaller compared with 7.9% of those who took a placebo plus gemcitabine.
  • The length of response in patients whose cancer responded to treatment with Tarceva plus gemcitabine for advanced-stage pancreatic cancer in a clinical trial was 5.5 months compared with 5.4 months for those who took a placebo plus gemcitabine.

Tarceva is a once-a-day pill

You take Tarceva by mouth once a day, at least 1 hour before or 2 hours after eating.

In addition to understanding the benefits of Tarceva, it is also important to know the side effects and safety information about Tarceva. Please see Important Safety Information below to learn more.

*
Median is the midpoint of a range of numbers.
Progression-free survival is a term used to describe the amount of time that patients live without their disease getting worse or progressing. In a clinical trial, measuring progression-free survival is one way to see how well a new treatment works.

See Tarceva Important Safety Information

Who is Tarceva® (erlotinib) for?

Tarceva is approved as a 1st-line treatment, maintenance treatment, and 2nd- or 3rd-line treatment for advanced-stage non-small cell lung cancer (NSCLC).

  • Tarceva is prescribed as initial treatment for patients with NSCLC whose cancer has spread to other parts of the body and that has certain types of epidermal growth factor receptor (EGFR) mutations. (1st-line treatment) Your healthcare provider will perform a test to make sure that Tarceva is right for you.
  • Tarceva is prescribed as maintenance treatment for advanced-stage NSCLC in patients whose cancer has not spread or grown after prior treatment with certain types of chemotherapy.
  • Tarceva is prescribed as 2nd- or 3rd-line treatment for advanced-stage NSCLC in patients whose cancer has spread or grown after receiving at least one round of chemotherapy.
  • Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.
  • For initial treatment of patients with NSCLC whose cancer has spread to other parts of the body, it is not known if Tarceva is safe and effective in EGFR mutations other than those included in the FDA-approved prescribing information.

Tarceva is approved for advanced-stage pancreatic cancer.

  • Tarceva in combination with gemcitabine is prescribed for patients with advanced-stage pancreatic cancer whose cancer has spread, grown, or cannot be surgically removed and who have not received previous chemotherapy.

Important Safety Information

What is the most important information I should know about Tarceva?

Everyone reacts differently to treatment with Tarceva. It’s important to know the most serious and most common side effects with Tarceva.

Your healthcare provider (HCP) may lower the dose or stop treatment with Tarceva if any serious side effects occur. Contact your HCP right away if you have any of the following side effects.

What are the possible side effects of Tarceva?

Tarceva can cause serious side effects, including:

  • Lung problems (called interstitial lung disease [ILD] events). Tarceva has been shown to cause lung problems, including death. Symptoms of lung problems may include shortness of breath, cough, and fever. Tarceva may need to be stopped if you have any of these symptoms
  • Liver and kidney problems. Tarceva has been shown to cause severe kidney and liver problems, including death. Some people had their kidneys and liver stop working. Let your HCP know if you have a history of liver or kidney disease
  • Stomach and intestinal problems (called gastrointestinal [GI] perforation). Tarceva has been shown to cause GI perforation, which has led to death. A GI perforation is a hole that develops in your stomach or intestine. People may be at a higher risk for GI perforation if they:
    • Are taking medicines including those that may help block the growth of blood vessels; steroids; nonsteroidal anti-inflammatory drugs (NSAIDs); and certain chemotherapies. Always tell your HCP about any medicines you are taking
    • Have a history of ulcers or other stomach disease
  • Serious skin conditions. Tarceva has been shown to cause blistering and skin peeling. This may result in other serious skin disorders or death
  • Blood, bleeding, and clotting problems. Tarceva has been shown to cause certain blood problems and other bleeding and clotting problems. These have led to heart attack, stroke, and death
  • Eye disorders. Tarceva has been shown to cause dry eyes, unusual eyelash growth, or swelling of the cornea. The cornea is the clear coating of the eyeball. This swelling may irritate or damage the eye
  • Bleeding events when taking warfarin with Tarceva. Tell your HCP if you are taking a blood thinner, such as warfarin, or NSAIDs. Examples of NSAIDs include aspirin, naproxen, and ibuprofen. Your HCP can tell you the names of other NSAIDs. Taking Tarceva with these medicines can cause death
  • Pregnancy. Tarceva can harm an unborn baby. Women should use effective birth control during treatment and for at least 2 weeks after the last dose of Tarceva. Tell your HCP if you have become pregnant, or if you think you may be pregnant, during treatment with Tarceva. Do not breast-feed during treatment with Tarceva

When should I call my HCP while taking Tarceva?

Call your HCP if you have:

  • Serious or ongoing diarrhea, nausea (feeling sick to your stomach), loss of appetite, or vomiting
  • New or worsening shortness of breath or cough
  • Eye irritation
  • New or worsening rash, blistering, or peeling of the skin
  • Any changes in smoking habits

What are some of the most common side effects of Tarceva?

    • In first-line NSCLC treatment:
      • Diarrhea
      • Weakness
      • Rash
      • Cough
      • Shortness of breath
      • Loss of appetite (not wanting to eat)
    • In maintenance / second- or third-line NSCLC treatment:
      • Rash
      • Diarrhea
    • In pancreatic cancer treatment:
      • Fatigue (feeling very tired)
      • Rash
      • Nausea
      • Loss of appetite
      • Diarrhea

What should I know about skin (including rash), hair, and nail problems or diarrhea while taking Tarceva?

  • Skin (including rash):
    • Your skin may look red with little bumps. This may look like acne, but it is not. The rash usually appears on the face, upper chest, and back. It could spread to other parts of the body. The skin may start peeling. The rash could happen or get worse if the skin is exposed to the sun. You may feel itching, tenderness, or burning where you have the rash
    • Your skin and nails may get darker. You may also have dry skin that may or may not crack. This most often happens with rash
    • While taking Tarceva, you may want to use alcohol-free lotions and sunscreens or avoid being out in the sun
    • In Tarceva clinical trials, rash was treated with steroids or antibiotics. Using acne medicines may dry your skin and make the rash worse. The treatment of rash has not been studied
    • Talk with your HCP if you notice a rash. He or she may be able to help you manage it
  • Hair and nails:
    • Hair and nail problems have been seen in patients taking Tarceva. These include increased hairiness and brittle or loose nails
  • Diarrhea:
    • Diarrhea can usually be treated with antidiarrhea medicine. Your HCP can help you find the right medicine for you

What should I do if I am taking or am prescribed other medicines or supplements while taking Tarceva?

  • Always 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
  • DO NOT eat grapefruit or drink grapefruit juice before talking with your HCP

Will smoking affect my treatment with Tarceva?

  • If you smoke, you should stop smoking before you start treatment with Tarceva
  • If you continue to smoke, your treatment with Tarceva may need to be adjusted. Talk with your HCP if you continue to smoke

Always talk with your HCP about any side effects you may have with Tarceva.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the Tarceva full Prescribing Information for additional Important Safety Information.