This medicine is a tyrosine kinase inhibitor used to treat certain types of advanced or metastatic lung cancer. It is also used to treat certain types of pancreatic cancer, in combination with gemcitabine.
Follow the directions for taking this medicine provided by your doctor. AN ADDITIONAL PATIENT INFORMATION LEAFLET may be available with this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE 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 this medicine. EATING GRAPEFRUIT OR DRINKING GRAPEFRUIT JUICE while you are taking this medicine may increase the amount of this medicine in your blood, which may increase your risk for serious side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet. If you take a H2 receptor antagonist (eg, ranitidine) or an antacid, talk with your doctor or pharmacist about how to take these medicines together. STORE THIS MEDICINE at 77 degrees F (25 degrees C) 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 THIS MEDICINE out of the reach of children and away from pets. Take this medicine regularly to get the most benefit from it. Taking this medicine at the same time each day will help you to remember. IF YOU MISS A DOSE OF THIS MEDICINE, contact your doctor right away.
Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking a proton pump inhibitor (PPI) (eg, omeprazole). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (eg, warfarin), azole antifungals (eg, itraconazole, ketoconazole, voriconazole), barbiturates (eg, phenobarbital), certain calcium channel blockers (eg, diltiazem, verapamil), carbamazepine, corticosteroids (eg, prednisone), efavirenz, fluoroquinolone antibiotics (eg, ciprofloxacin), HIV protease inhibitors (eg, atazanavir, indinavir, nelfinavir, ritonavir, saquinavir), HMG CoA-reductase inhibitors (statins) (eg, simvastatin), hydantoins (eg, phenytoin), macrolide antibiotics (eg, clarithromycin), nefazodone, nevirapine, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), pioglitazone, rifamycins (eg, rifampin, rifabutin, rifapentine), St. John's Wort, telithromycin, troleandomycin, or medicines that may harm the kidney (eg, aminoglycoside antibiotics, such as gentamicin; amphotericin B; cyclosporine; tacrolimus; vancomycin) or the liver (eg, acetaminophen, methotrexate, isoniazid, certain medicines for HIV infection). Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of stomach or bowel problems (eg, peptic ulcer, diverticular disease, bleeding), liver problems or abnormal liver function tests, kidney problems, heart or blood vessel problems, lung problems (eg, lung disease, lung infection), eye problems (eg, cataracts), allergies, pregnancy or if you are able to become pregnant, or breast-feeding. Tell your doctor if you have certain rare hereditary problems (galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption), dehydration, diarrhea or vomiting, or a rash or other skin condition. Tell your doctor if you smoke tobacco, wear contacts, if you have had or are receiving radiation therapy or chemotherapy, or if you have had a certain type of surgery (eg, cataract surgery). Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while taking this medicine 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, or weight loss. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience 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); or vomit that looks like coffee grounds. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include rash, or severe or persistent diarrhea.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIMED, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.