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.

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.

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.

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.

Contact your doctor if you miss a dose of erlotinib.

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.

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

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.

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

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

Erlotinib is available with a prescription under the brand name Tarceva. Other brand or generic formulations may also be available. Ask your healthcare provider or pharmacist any questions you have about this medication, especially if it is new to you.

• Tarceva 25 mg-white film-coated tablets
• Tarceva 100 mg-white film-coated tablets
• Tarceva 150 mg-white film-coated tablets