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Frequently Asked Questions (FAQs)

Tarceva FAQs


What is Tarceva?
Tarceva is a pill taken once a day on an empty stomach, at least one hour before or two hours after eating, to treat your advanced-stage non-small cell lung cancer (NSCLC) or advanced-stage pancreatic cancer.

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)
  • 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.

What is 1st-line treatment?
1st-line treatment is given to patients as an initial therapy for their cancer. Tarceva can be prescribed as a 1st-line therapy for patients with metastatic NSCLC and certain types of EGFR mutations.

  • 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.

What is 2nd- or 3rd-line treatment?
2nd- or 3rd-line treatment is given when the previous treatment does not work or has stopped working. Tarceva can be prescribed as 2nd- or 3rd-line treatment for advanced-stage NSCLC.

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

How is Tarceva thought to work?
Tarceva is not a conventional chemotherapy drug. The way Tarceva works to treat cancer is not fully known. Tarceva is a kind of therapy that affects certain signals needed for cancer cells to grow. It also affects healthy cells. Tarceva may slow or block the activity of a specific protein called epidermal growth factor receptor (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 healthcare provider (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 serious adverse reactions associated with Tarceva?
Tarceva can cause serious side effects, which include:

  • Interstitial lung disease, or 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. 
  • Gastrointestinal (GI) perforation. Tarceva has been shown to cause GI perforation, a hole that develops in your stomach or intestine, which has led to death. People taking Tarceva at the same time as medications that may help block the growth of blood vessels, steroids, non-steroidal anti-inflammatory drugs (NSAIDs), or certain chemotherapies or those who have a history of ulcers or other stomach disease may be at higher risk of perforation. 
  • 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. This swelling may irritate the eye or cause damage.
  • Bleeding events when taking warfarin with Tarceva. Tell your HCP if you are taking a blood thinner, such as warfarin, or non-steroidal anti-inflammatory drugs, known as NSAIDs. Taking Tarceva with these medications can cause death. 
  • Pregnancy. Tarceva can cause harm to an unborn baby. Do not breast-feed when taking Tarceva. Women should use effective birth control during treatment and for at least 2 weeks after the last dose of Tarceva. Contact your HCP if you have become pregnant or if pregnancy is suspected, during treatment with Tarceva.

Please let your HCP know if you experience any of the following:

  • Serious or ongoing diarrhea, nausea, 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 the most common side effects I may experience with Tarceva?

  • 1st-line metastatic NSCLC treatment: Diarrhea, weakness, rash, cough, shortness of breath, and loss of appetite.
  • Maintenance/2nd- or 3rd-Line advanced-stage NSCLC treatment: Rash and diarrhea.
  • Advanced-stage pancreatic cancer treatment: Fatigue (feeling tired), rash, nausea, loss of appetite, and diarrhea.

Does Tarceva really work?
Please see possible benefits of Tarceva and Indications and Important Safety Information for Tarceva.


How do I know if I am a candidate for Tarceva?
Tarceva may be prescribed as initial treatment for patients with metastatic NSCLC whose tumors have certain types of EGFR mutations and as maintenance treatment or as 2nd- or 3rd-line treatment for locally advanced or metastatic NSCLC. You may be a candidate for initial treatment with Tarceva if you have metastatic NSCLC and certain types of EGFR mutations. 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 2nd- or 3rd-line treatment if previous chemotherapy did not work or stopped working. Tarceva may be prescribed in combination with gemcitabine as treatment for advanced-stage pancreatic cancer in patients whose cancer has spread, grown, or cannot be surgically removed and who have not received previous chemotherapy. Speak with your doctor about whether Tarceva is right for you.

  • Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced-stage 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.

When in my treatment regimen can Tarceva be used?
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)
  • 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-stage 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 iin 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.

What can I do if I experience a rash when taking Tarceva?
Rash is a common side effect of Tarceva. If you get a rash, it may be upsetting. But do not stop taking Tarceva unless your HCP tells you to stop. Call your HCP and let him or her know. Your HCP may:

  • Prescribe or recommend products to manage the rash
  • Decrease the amount of Tarceva you take, tell you not to take it for a short time, or tell you to stop taking it completely

Please see Side Effects for more information. Also, it's important to take Tarceva on an empty stomach at least 1 hour before or 2 hours after eating. Taking Tarceva with food may increase your chance of developing side effects.


When should I call my doctor?
Call your doctor right away for any of the following:

  • 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

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 1 hour before or 2 hours after eating.

Take Tarceva at the same time each day between meals.


Where can I get Tarceva?
You are probably used to getting your medicine at your local drug store, but Tarceva is sold through specialty pharmacies. These specialty pharmacies deliver prescriptions primarily through the mail and send the medicine right to your home.
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 calls Tarceva Access Solutions, you can speak with one of our dedicated Access Solutions Specialists, whose 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 (888) 249-4918 and speak live with one of our Specialists or visit https://www.genentech-access.com/patient/brands/tarceva.html.


How long has Tarceva been available?

The Food and Drug Administration (FDA) approved Tarceva for 2nd- or 3rd-line treatment of advanced-stage non-small cell lung cancer (NSCLC) on November 18, 2004.

In November 2005, Tarceva was approved by the FDA in combination with gemcitabine for treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

In April 2010, Tarceva was approved by the FDA as maintenance therapy for patients with advanced-stage NSCLC.

In May 2013, Tarceva was approved by the FDA as initial therapy for patients with NSCLC whose cancer has spread to other parts of the body and who have certain types of epidermal growth factor receptor (EGFR) mutations.


Are there Tarceva clinical trials available for patients with advanced-stage NSCLC or advanced-stage pancreatic cancer?
You can find information on clinical trials of Tarceva by visiting www.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 Safety Information for Tarceva below.


 

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.