Advanced Breast Cancer: Learn about treatment options.

Generic Name: erlotinib (er-LOE-ti-nib)
Brand Name: Tarceva

Tarceva is used for:

Treating certain types of advanced or metastatic lung cancer. It is also used to treat certain types of pancreatic cancer in combination with another medicine (gemcitabine).

Tarceva is a tyrosine kinase inhibitor. It works by helping to stop cancer cells from growing.

Do NOT use Tarceva if:

  • you are allergic to any ingredient in Tarceva
  • you are being treated with a platinum-based chemotherapy (eg, cisplatin, carboplatin)
  • you are also taking a proton pump inhibitor (PPI) (eg, omeprazole)

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Tarceva:

Some medical conditions may interact with Tarceva. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of stomach or bowel problems (eg, peptic ulcer, diverticular disease, bleeding), liver problems or abnormal liver function tests, kidney problems, or heart or blood vessel problems
  • if you have a history of lung problems (eg, lung disease, lung infection) or eye problems (eg, cataracts)
  • if you smoke tobacco, are dehydrated, have diarrhea or are vomiting, or have a rash or another skin condition
  • if you have had or are receiving radiation therapy or chemotherapy
  • if you wear contact lenses or you have had a certain type of eye surgery (cataract surgery)
  • you have certain rare hereditary problems (galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption)

Some MEDICINES MAY INTERACT with Tarceva. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, itraconazole, ketoconazole, voriconazole), certain calcium channel blockers (eg, diltiazem, verapamil), fluoroquinolone antibiotics (eg, ciprofloxacin), HIV protease inhibitors (eg, atazanavir, indinavir, nelfinavir, ritonavir, saquinavir), macrolide antibiotics (eg, clarithromycin), nefazodone, telithromycin, or troleandomycin because they may increase the risk of Tarceva's side effects
  • Barbiturates (eg, phenobarbital), carbamazepine, efavirenz, hydantoins (eg, phenytoin), nevirapine, pioglitazone, PPIs (eg, omeprazole), rifamycins (eg, rifabutin, rifampin, rifapentine), or St. John's wort because they may decrease Tarceva's effectiveness
  • Corticosteroids (eg, prednisone), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or certain other medicines because the risk of stomach or bowel problems may be increased
  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
  • HMG-CoA reductase inhibitors (statins) (eg, simvastatin) because the risk of muscle problems may be increased
  • Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, NSAIDs [eg, ibuprofen], tacrolimus, vancomycin) or the liver (eg, acetaminophen, certain medicines for HIV infection, isoniazid, ketoconazole, methotrexate) because the risk of kidney or liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tarceva may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tarceva:

Use Tarceva as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Tarceva by mouth with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.
  • Wash your hands immediately after taking Tarceva.
  • Eating grapefruit or drinking grapefruit juice while you are taking Tarceva may increase the amount of Tarceva in your blood, which may increase your risk of serious side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
  • Take Tarceva on a regular schedule to get the most benefit from it. Taking Tarceva at the same time each day will help you to remember to take it.
  • If you take an H2 receptor antagonist (eg, ranitidine) or an antacid, talk with your doctor or pharmacist about how to take these medicines together.
  • If you miss a dose of Tarceva, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Tarceva.

Important safety information:

  • If you experience moderate to severe diarrhea, nausea, loss of appetite, or vomiting, or a severe skin reaction, tell your doctor right away. Your doctor may need to reduce your dose or interrupt treatment. Do not treat diarrhea with nonprescription medicines. You will need to take care not to become dehydrated. Contact your doctor for instructions.
  • Check with your doctor before you smoke or use other tobacco products while using Tarceva. Tobacco products may decrease Tarceva's effectiveness.
  • Women who may become pregnant should use effective birth control while they are taking Tarceva and for at least 2 weeks after treatment is complete. Check with your doctor if you have questions about effective birth control.
  • Tarceva may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Tarceva may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Tarceva may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Tarceva. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Tell your doctor or dentist that you take Tarceva before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including liver, kidney, and lung function; eye exams; and blood electrolytes, may be performed while you use Tarceva. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Tarceva with caution in the ELDERLY; they may be more sensitive to its effects.
  • Tarceva should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Tarceva may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Tarceva is found in breast milk. Do not breast-feed while you are taking Tarceva.

Possible side effects of Tarceva:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; constipation; diarrhea; dizziness; dry skin; fatigue; hair loss; headache; loss of appetite; mild rash or itching; mild stomach pain or upset; mouth sores or ulcers; nail changes; nausea; tiredness; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal eyelash growth; black, tarry stools; bone pain; chest, jaw, or arm pain; changes in the amount of urine produced; confusion; excessive hair growth; eye pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; muscle pain, weakness, or cramping; new or worsening lung problems (eg, shortness of breath, cough); nosebleed; one-sided weakness; red, swollen, blistered, or peeling skin; severe eye dryness, irritation, redness, or discharge; severe or persistent diarrhea, nausea, loss of appetite, stomach pain, or vomiting; severe rash accompanied by fever, blistering, mouth sores, swelling, muscle or joint aches, or discomfort; slurred speech; swelling of the hands, legs, or feet; symptoms of liver problems (eg, dark urine, pale stools, right-sided stomach pain, yellowing of the skin or eyes); unusual bruising or bleeding; unusual sweating; unusual tiredness or weakness; vision problems (eg, decrease in vision, loss of vision); vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe or persistent diarrhea; rash.

Proper storage of Tarceva:

Store Tarceva at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. Keep Tarceva out of the reach of children and away from pets.

General information:

  • If you have any questions about Tarceva, please talk with your doctor, pharmacist, or other health care provider.
  • Tarceva is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Tarceva or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tarceva. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Tarceva. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Tarceva.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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