Option Tarceva

Possible Benefits of Tarceva

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• How to Take Tarceva

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 in people with advanced NSCLC who received Tarceva as maintenance treatment:

In a large study in people with advanced NSCLC who have not taken Tarceva before and whose cancer has grown or spread after at least 1 prior chemotherapy regimen:

Tarceva may offer convenience

You take the pill by mouth once a day on an empty stomach.
In addition to understanding the benefits of Tarceva, it is also important to know the side effects and safety information about Tarceva. This information appears below.
*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.
Indications and Usage for Advanced Non-Small Cell Lung Cancer Patients Tarceva is prescribed for patients with advanced-stage Non-small Cell Lung Cancer (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 Non-Small Cell Lung Cancer (NSCLC) whose cancer has spread or grown after receiving at least 1 chemotherapy regimen. (2^nd/3^rd-line treatment)
Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.

Important Safety Information

Possible effects on the lungs

There have been reports of serious adverse events involving the lungs in a small number of patients taking Tarceva. These events have included death in some patients. The medical name for these types of events is interstitial (in-tur-STISH-ul) lung disease-like events (or ILD-like events).

Possible effects on the kidneys and liver

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

Possible effects on the stomach and intestines

Some patients taking Tarceva have developed a hole in the lining of their stomach or intestines (including deaths). It may happen more in patients who are taking certain other medicines or who have had certain stomach or intestinal diseases.

Possible effects on the skin

Some patients taking Tarceva have developed serious skin conditions. Some patients have died from these conditions.

Possible effects on the eye

Some patients taking Tarceva have developed eye irritation and damage to the cornea. The cornea is the clear part of the eyeball that covers the colored part of the eye and the pupil. Other eye problems such as abnormal eyelash growth, dry eyes, or changes in eyesight have also been reported. Patients should tell their HCP about eye problems that get worse, including eye pain.

When to call your HCP

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

Before you start taking Tarceva

Some patients taking Tarceva have experienced difficulty with blood clotting, and bleeding events, including gastrointestinal and non-gastrointestinal bleeding. Patients taking blood thinners (Coumadin^®, warfarin or other coumarin-derivatives) should be monitored regularly.

Taking other medicines and herbal supplements with Tarceva

Certain medicines and herbal supplements can affect how Tarceva works in the body. 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. Tarceva may also affect other medications you are taking.
In addition, grapefruit and grapefruit juice have an effect on how Tarceva works. DO NOT eat grapefruit or drink grapefruit juice while on treatment with Tarceva, except under the care of your HCP.
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Common side effects of Tarceva

The most common side effects in patients who took Tarceva were generally mild to moderate rash and diarrhea. You may also have other changes in your skin.
The rash from Tarceva therapy may appear on your upper body or face. Typically rash occurs within 8 days of starting treatment, but it may occur any time during treatment with Tarceva.
The rash is not an allergic reaction. It may look like acne or dry skin. It is not acne. Talk to your HCP if a rash occurs.
Typically, diarrhea may develop within 12 days of starting Tarceva.
Hair and nail changes have been seen with Tarceva.