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Tarceva® erlotinib tablets
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I did get the rash. At first I thought it might be an allergic reaction or acne. But then I realized it was the rash my nurse told me about. I gave her a call. My nurse told me to use a moisturizing cream. - Tarceva patient

Managing Rash and Other Most Serious Common Side Effects

Pancreatic Cancer Treatment
Side effect Moderate Severe
Fatigue 14% 2%
Rash 5% 0%
Nausea 7% 0%
Loss of appetite 6% <1%
Diarrhea 5% <1%

You may also have other changes in your skin. Your doctor may adjust the amount of Tarceva you are taking if you develop a rash.

Let your doctor or nurse know if you experience side effects.

Side Effect Self-Help Tips
Rash and other skin changes. Soon after you start taking Tarceva, a rash may appear, most often on your face, upper chest, and back. However, a rash may appear anywhere on your body with symptoms such as itching, tenderness, burning, dryness, or cracked skin on your fingers and hands. It may look like acne or dry skin. Rash is a common side effect of Tarceva. If you get a rash while on Tarceva, call your doctor about what to do, as some patients have experienced serious skin conditions.
  • Use a mild soap to wash the affected area.
  • Moisturize the area with a mild, alcohol-free cream.
  • Avoid sun exposure.
  • Use a sunscreen of SPF 15 or higher, preferably containing zinc oxide or titanium dioxide.
  • Wear a hat.
  • Avoid over-the-counter acne-related treatments, including products with benzoyl peroxide.
  • Remove any dermatologist-approved makeup with a gentle liquid cleanser.
Diarrhea. This is most likely to occur within the first week or two of Tarceva treatment. As directed by your doctor, diarrhea may be treated with over-the-counter antidiarrhea products. Ask your doctor which product may be right for you. If your diarrhea worsens or persists, tell your doctor.
  • Take small sips of liquids (such as sports drinks without sugar) often throughout the day.
  • Eat mild food, such as toast and crackers.
  • Limit spicy foods.
  • Consider loperamide, an over-the-counter drug used to help treat diarrhea.
Indications and Usage for Advanced Pancreatic Cancer Patients

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
Possible effects on the lungs

There have been reports of serious 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 patient 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 certain stomach and 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 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

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.

Tarceva and pregnancy and breast-feeding

Women should not become pregnant while on treatment with Tarceva. If you are already pregnant or become pregnant while taking Tarceva, you should talk with your HCP about the benefits and risks of continuing to take Tarceva.

DO NOT breast-feed while receiving treatment with Tarceva.

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 for 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.

Smoking

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 with your HCP before taking Tarceva.

Common side effects of Tarceva

The most common side effects in patients who took Tarceva plus gemcitabine were fatigue “feeling tired”, rash, nausea, loss of appetite, and diarrhea. Other skin changes may also be seen.

The rash from Tarceva plus gemcitabine therapy may appear on your upper body or face. Typically rash occurs within 10 days of starting treatment, but it may occur any time during treatment.

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 15 days of starting Tarceva plus gemcitabine therapy.

Hair and nail changes have been seen with 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.


Genentech Biooncology Astellas Oncology

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Tarceva® erlotinib tablets