TARCEVA (erlotinib) 25mg, 100mg & 150mg

Patient Education - English

• Generic Name: erlotinib

• Pronounced: er LOE ti nib

• Brand Name: Tarceva

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

If you experience any of the following serious side effects from erlotinib, 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 erlotinib?

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

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

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

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

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

• liver disease; or
• lung or breathing problems (other than lung cancer).

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

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

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

How should I use erlotinib?

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

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

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

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

Your doctor will determine the correct amount, frequency and duration of treatment with erlotinib 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.

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

What happens if I miss a dose?

Contact your doctor if you miss a dose of erlotinib.

What happens if I overdose?

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

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

What should I avoid while using erlotinib?

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

What are the possible side effects of erlotinib?

If you experience any of the following serious side effects from erlotinib, 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.

Other, less serious side effects may be more likely to occur. Continue taking erlotinib 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.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect erlotinib?

Before taking erlotinib, 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.

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

Grapefruit and grapefruit juice may interact with erlotinib. The interaction could lead to 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.

Many other drugs may interact with erlotinib. 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?

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

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.

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.