Important Information to Know
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Some rare, but possibly serious, side effects may occur with Tarceva (erlotinib).
In clinical studies, there were infrequent reports of lung injuries similar to Interstitial Lung Disease (ILD) in patients receiving Tarceva for the treatment of NSCLC or other advanced solid tumors. Reports of these ILD-like lung injuries have been serious and have included deaths in some patients. In patients receiving Tarceva for NSCLC in a clinical study, the incidence of ILD-like events was approximately 0.8%. No difference was seen in the number of patients with ILD who took Tarceva, compared with patients on sugar pills.
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.
Tarceva may cause liver and/or kidney problems in some patients. Cases of serious liver or kidney problems, including deaths, have been seen. Let your doctor know if you have a history of liver or kidney disease.
Call your doctor right away if you have these signs or symptoms:
- Serious or persistent diarrhea, nausea, loss of appetite or vomiting
- New or worsening shortness of breath or cough
- Eye irritation
Before you start taking Tarceva
Clinical studies have shown that taking Tarceva with certain foods and other drugs may affect how well Tarceva may work for you. Let your doctor know if you are taking other prescription and over-the-counter drugs or herbal supplements. Do not eat grapefruit or drink grapefruit juice while taking Tarceva. Tarceva may also affect other medications you are taking.
When taking Tarceva with some drugs, such as blood thinners (Coumadin® *, warfarin), there may be an increased risk of bleeding.
If you smoke, you should stop smoking while taking Tarceva as it may affect how well Tarceva may work for you.
Common side effects of Tarceva
Rash and diarrhea were the most common side effects associated with Tarceva. They were usually mild to moderate. In clinical studies, severe rash and diarrhea occurred in 9% and 6% of patients, respectively. You may also have other changes in your skin.
The rash associated with the Tarceva therapy may appear on your body or face, typically within 8 days of starting this treatment. However, the rash may occur anytime 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 doctor if a rash occurs.
Typically, diarrhea may develop within 12 days of starting the Tarceva.
In the NSCLC clinical study, Tarceva did not have some of the side effects of traditional chemotherapy, such as a low number of infection-fighting white blood cells. Tarceva was also less likely to be associated with total hair loss.
Always let your doctor or nurse know if you experience any side effects. Your doctor may change your dose. Ask your doctor or nurse for the best way to handle drug-related side effects.
*Coumadin® is a registered trademark of Bristol-Myers Squibb Company.
are trademarks of OSI Pharmaceuticals, Inc.
