Managing Tarceva Common Side Effects

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Fatigue, rash, nausea, loss of appetite and diarrhea were the most common side effects associated with the Tarceva (erlotinib) plus gemcitabine therapy in a large clinical study. Severe rash and diarrhea were each reported in 5% of patients receiving Tarceva plus gemcitabine therapy in this same large clinical study.

The rash associated with the Tarceva (erlotinib) plus gemcitabine therapy may appear on your body or face, typically within 10 days of starting this treatment. However, the rash may occur anytime during treatment with Tarceva plus gemcitabine. The rash associated with Tarceva is not an allergic reaction and may look like acne or dry skin. Please contact your doctor if you develop a rash, as some rashes have been serious (or similar).

Typically, diarrhea may develop within 15 days of starting the Tarceva plus gemcitabine therapy.

What you can do to ease the common side effects of Tarceva plus gemcitabine

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.

You may be able to take steps to ease some of the side effects you may experience during treatment. A list of self-help tips are included in the chart below. Ask your doctor or nurse for more ways to help ease these or any other possible side effects.

Some side effects of the disease itself, such as nausea and vomiting, may make it difficult for you to take your Tarceva. If that happens, let your doctor or nurse know.

Always take Tarceva as prescribed by your doctor

Taking Tarceva with food may increase your chance of developing side effects. For this reason, it's important to take Tarceva at least one hour before or two hours after eating.

Side effect	Self-help tips
Fatigue	Take short rests throughout the day. Know your limits. Ask family and friends for help with chores.
Rash	Use a mild soap and lukewarm water to wash the affected area. Moisturize the area with a mild alcohol-free cream. Limit direct sun exposure. Use a sunscreen appropriate for sensitive skin (SPF 15 or higher), preferably containing zinc oxide or titanium dioxide. Avoid over-the-counter acne-related treatments, including products with benzoyl peroxide. Remove any dermatologist-approved makeup with a gentle liquid cleanser.
Loss of appetite	Eat small snacks when you are able. Take a walk before eating to build up an appetite.
Nausea and vomiting	Try eating and drinking slowly. Avoid eating greasy foods.
Diarrhea	Take small sips of liquids (such as sports drinks without sugar) often throughout the day. Eat mild foods, such as toast and crackers. Limit spicy foods.

Some patients have reported serious side effects with Tarceva. Talk to your doctor about any side effects you may have.

Checking your progress with regular follow-up visits

Your doctor will check to see how well your treatment is working during regular follow-up visits.
As part of a regular physical exam, you may undergo a Computed Tomography (CT) scan or other imaging tests.
Blood tests may also be used to measure the effectiveness of your treatment.

Please see full Prescribing Information

Indication and Usage for Advanced Pancreatic Cancer Patients

Tarceva in combination with gemcitabine is prescribed for patients with advanced-stage pancreatic cancer who have not received previous chemotherapy.

Important Safety Information

Possible effects on the lungs

In clinical studies, there were infrequent reports of lung injuries similar to Interstitial Lung Disease (ILD)-like events in patients taking Tarceva for the treatment of pancreatic cancer or other advanced solid tumors. Reports of these ILD-like lung injuries have been serious and have included deaths in some patients.

Possible effects on the kidneys and liver

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

Possible effects on the stomach and intestines

Holes that formed in the stomach, small intestine, or large bowel (including deaths) have been reported in patients taking Tarceva.

Possible effects on the skin

Severe blistering skin reactions including cases similar to Stevens-Johnson syndrome (including deaths) have been reported in patients taking Tarceva.

Possible effects on the veins and heart

Patients taking Tarceva plus gemcitabine were more likely to experience bleeding and clotting problems such as heart attack or stroke.

Possible effects on the eye

Eye irritation and damage to the cornea have been reported in patients taking Tarceva. Patients should tell their doctor about eye problems, including eye pain, that get worse.

Tarceva and pregnancy and breast-feeding

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.

When to call your HCP

Call your doctor right away if you have these signs or symptoms:

New or worsening skin rash
Serious or ongoing diarrhea, nausea, loss of appetite, vomiting, or stomach pain
New or worsening shortness of breath or cough
Fever
Eye irritation

If you smoke, you should stop smoking while taking Tarceva, as it may affect how well Tarceva works for you. If you continue to smoke you should speak to your doctor before taking Tarceva.

Let your doctor know if you are taking other prescription or over-the-counter drugs or herbal supplements before you start taking Tarceva. While taking Tarceva, do not start taking any new drugs or herbal supplements before talking to your doctor. Do not eat grapefruit or drink grapefruit juice while taking Tarceva. Tarceva may also affect other medications you are taking.

Common side effects of Tarceva

Fatigue, rash, nausea, loss of appetite, and diarrhea were the most common side effects associated with Tarceva plus gemcitabine therapy in a large clinical study.

Always let your doctor or nurse know if you experience any side effects. Ask your doctor or nurse for the best way to handle drug-related side effects.

Tarceva is not right for everyone. Ask your doctor if once-daily Tarceva is right for you.

Please see the Tarceva full prescribing information for complete safety information.