Possible Benefits of Tarceva
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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 of 438 people with advanced non-small cell lung cancer (NSCLC) who received Tarceva as maintenance treatment:

*Median is the midpoint of a range of numbers. This means that half the patients had a shorter overall survival time and half had a longer overall survival time.
- Patients who took Tarceva had a 29% reduction in the risk of their cancer getting worse or of death.
In a large study of 731 people with advanced NSCLC who had not taken Tarceva before and whose cancer had grown or spread after at least 1 prior chemotherapy regimen:

*Median is the midpoint of a range of numbers. This means that half the patients had a shorter overall survival time and half had a longer overall survival time.
- Patients who took Tarceva had a 41% reduction in the risk of their cancer getting worse or of death.
Tarceva is a once-a-day pill
You take the pill by mouth once a day on an empty stomach.
In addition to understanding the potential benefits of Tarceva, it is also important to know the safety information about Tarceva. This information appears below.
- Tarceva is prescribed for patients with advanced-stage 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 NSCLC whose cancer has spread or grown after receiving at least 1 chemotherapy regimen (2nd/3rd-line treatment).
- Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.
Everyone reacts differently to Tarceva therapy. So it’s important to know what the side effects are. Although some people may have a life-threatening side effect, most do not.
Your doctor will stop treatment if any serious side effects occur. Be sure to contact your healthcare team if you have symptoms related to these side effects.
Interstitial lung disease (ILD)-like events
Problems occurring in the lungs (including deaths). Tarceva may need to be stopped if new or unexplained serious symptoms of shortness of breath, cough, and fever occur.Liver and/or kidney problems
Some events have included death. Let your healthcare provider (HCP) know if you have a history of liver or kidney disease.Gastrointestinal (GI) perforation
A hole that develops in your stomach or intestine. Some events have included death.Serious skin conditions
Some events have included death.Eye disorders
Eye irritation and damage to the cornea.Bleeding events when taking warfarin
Some events have included death. Tell your doctor if you are taking warfarin or non-steroidal anti-inflammatory drugs (NSAIDs).Pregnancy problems
You should not become pregnant while on treatment with Tarceva. DO NOT breast-feed while receiving treatment with Tarceva.
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, or vomiting
- New or worsening shortness of breath or cough
- Eye irritation
The most common side effects are generally mild to moderate rash and diarrhea.
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.
- DO NOT eat grapefruit or drink grapefruit juice while on treatment with Tarceva, except under the care of your HCP.
Smoking may affect how well Tarceva works for you.
- If you smoke, you should stop smoking before starting treatment with Tarceva.
- If you continue to smoke, you should talk to your HCP before taking 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.
You may report side effects to the FDA at 1 (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1 (888) 835-2555.



