- PRESCRIPTION REQUIRED
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
ERLOTINIB - ORAL
COMMON BRAND NAME(S): Tarceva
USES: This medication is used to treat lung cancer. Erlotinib is used after other chemotherapy drugs have not been effective. It works by slowing cancer cell growth.
HOW TO USE: Take this medication by mouth on an empty stomach, at least 1 hour before or 2 hours after a meal, usually once daily, or as directed by your doctor. Do not take erlotinib within 2 hours of taking an antacid (liquid or tablets). Doing so can prevent the absorption of the medication. Acid-lowering medications for indigestion, heartburn, or ulcers (such as prescription or over-the-counter medications including famotidine, omeprazole) may prevent erlotinib from working. Ask your doctor or pharmacist how to use these medications safely. Use this medication regularly. Remember to take it at the same time every day. The dosage is based on your medical condition and response to therapy. Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may be increased. Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details. Since this drug can be absorbed through the skin, women who are pregnant or who may become pregnant should not handle or break the tablets of this medication.
SIDE EFFECTS: Nausea, vomiting, loss of appetite, mouth sores, dry skin, or eye irritation may occur. Changes in diet such as eating several small meals or limiting activity may help lessen the chance of nausea. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Diarrhea is a common side effect. Drink plenty of fluids as directed by your doctor to reduce your risk of losing too much body water. Your doctor may prescribe anti-diarrhea medication (e.g., loperamide) to control your symptoms. Tell your doctor immediately if you develop: severe or persistent diarrhea, signs of dehydration (e.g., dizziness, decreased amount of urine). Tell your doctor immediately if any of these rare but very serious side effects occur: black stools, vomit that looks like coffee grounds, easy bleeding/bruising, stomach/abdominal pain, yellowing eyes or skin, dark urine, unusual fatigue, signs of infection (e.g., fever, chills, persistent sore throat), eye pain, vision changes. Seek immediate medical attention if you develop any of these rare but very serious side effects: new or worsening shortness of breath or cough. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Erlotinib can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking erlotinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney problems, stomach/intestinal disease (such as ulcers, diverticulosis). Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured. This medicine may increase your risk of stomach bleeding. Limit alcoholic beverages. Sunlight may worsen any skin reactions that may occur while you are taking this drug. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. This drug is not recommended for use during pregnancy. It may cause harm to an unborn baby or miscarriage. Women of childbearing age should use reliable form(s) of birth control during treatment and for at least 2 weeks following the end of treatment with this drug. Consult your doctor for more details. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), corticosteroids (such as prednisone), drugs that lower stomach acid (some examples are H2 blockers such as famotidine/ranitidine, proton pump inhibitors such as omeprazole), drugs affecting liver enzymes that remove erlotinib from your body (such as azole antifungals, including itraconazole; macrolide antibiotics, including erythromycin; cimetidine; rifamycins, including rifabutin; St. John's wort; certain anti-seizure medicines, including carbamazepine; HIV protease inhibitors, including ritonavir). Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (nonsteroidal anti-inflammatory drugs-NSAIDs such as aspirin, celecoxib, ibuprofen, naproxen) which may increase your risk for stomach bleeding while you are taking erlotinib. Ask your pharmacist about the safe use of these products. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually these dosages are 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details. Cigarette smoking decreases blood levels of this medication. If you currently smoke, stop smoking while taking this medication. Consult your doctor or pharmacist for details. See also the How to Use section. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.
NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., kidney/liver function tests) should be performed to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature (77 degrees F or 25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).
Information last revised June 2010. Copyright(c) 2010 First Databank, Inc.