Consumer Information

Tarceva

erlotinib (er low TI nib)

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What is the most important information I should know about Tarceva?

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If you experience any of the following serious side effects from Tarceva, contact your doctor immediately:

an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

lung problems (especially new or worsening difficulty breathing, shortness of breath, increased coughing, fever, or chest pain);

severe or persistent nausea, vomiting, loss of appetite, or diarrhea; or

eye pain or irritation.

What is Tarceva?

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Tarceva is a cancer chemotherapy medication. Tarceva interferes with the growth of cancer cells and slows their growth and spread in the body.

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Tarceva is used in the treatment of non-small cell lung cancer.

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Tarceva may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Tarceva?

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Do not use Tarceva without first talking to your doctor if you have

liver disease; or

lung or breathing problems (other than lung cancer).

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You may not be able to take Tarceva, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

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Tarceva is in the FDA pregnancy category D. This means that it is known to be harmful to an unborn baby. Do not use Tarceva without first talking to your doctor if you are pregnant or could become pregnant during treatment. Birth control should be used during treatment with Tarceva and for at least 2 weeks after treatment completion.

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It is not known whether Tarceva passes into breast milk. Do not take Tarceva without first talking to your doctor if you are breast-feeding a baby.

How should I use Tarceva?

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Take Tarceva at least one hour before or two hours after eating.

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Take each dose of Tarceva with a full glass of water.

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It is important to take Tarceva regularly to get the most benefit.

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Your doctor may want you to have blood tests and other medical evaluations during treatment with Tarceva to monitor progress and side effects.

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Your doctor will determine the correct amount, frequency and duration of treatment with Tarceva depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

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Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

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Contact your doctor if you miss a dose of Tarceva.

What happens if I overdose?

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If an overdose of Tarceva is suspected, seek emergency medical attention or contact your healthcare provider immediately.

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Symptoms of a Tarceva overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using Tarceva?

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There are no restrictions on food, beverages, or activity during treatment with Tarceva unless otherwise directed by your doctor.

What are the possible side effects of Tarceva?

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If you experience any of the following serious side effects from Tarceva, contact your doctor immediately:

an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

lung problems (difficulty breathing, shortness of breath, increased coughing, fever, or chest pain);

severe or persistent nausea, vomiting, loss of appetite, or diarrhea; or

eye pain or irritation.

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Other, less serious side effects may be more likely to occur. Continue taking Tarceva and talk to your doctor if you experience:

mild to moderate nausea, vomiting, loss of appetite, or diarrhea;

skin rash, dryness, itching, or acne; or

weakness.

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Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with Tarceva.

What other drugs will affect Tarceva?

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Before taking Tarceva, tell your doctor if you are taking any other medicines, especially any of the following:

atazanavir (Reyataz), nelfinavir (Viracept), indinavir (Crixivan), saquinavir (Fortovase, Invirase), or ritonavir (Norvir);

rifampin (Rifadin, Rimactane), rifabutin (Mycobutin), or rifapentine (Priftin);

clarithromycin (Biaxin);

nefazodone;

telithromycin (Ketek);

troleandomycin (TAO);

carbamazepine (Tegretol);

phenobarbital (Luminal);

phenytoin (Dilantin, Phenytek);

ketoconazole (Nizoral), itraconazole (Sporanox), or voriconazole (Vfend); or

St. John's Wort.

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You may not be able to take Tarceva, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

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Grapefruit and grapefruit juice may interact with Tarceva. The interaction could lead to potentially adverse effects. You should discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

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Many other drugs may interact with Tarceva. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

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Your healthcare provider may have additional information about Tarceva that you may read.

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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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