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Lapatinib may cause liver damage which can be severe or life-threatening. Liver damage can occur as soon as several days or as late as several months after the start of treatment with lapatinib. Tell your doctor if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately: itching, yellowing of the skin or eyes, dark urine, pain in the upper right part of the stomach, unusual bleeding or bruising, or pale or dark stools.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain laboratory tests before and during your treatment to see whether your liver is likely to be damaged or has been damaged by lapatinib.
Talk to your doctor about the risks of taking lapatinib.
WHY is this medicine prescribed?
Lapatinib is used with capecitabine (Xeloda) to treat a certain type of advanced breast cancer in people who have already been treated with other chemotherapy medications. Lapatinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.
HOW should this medicine be used?
Lapatinib comes as a tablet to take by mouth. It is usually taken once a day, at least 1 hour before or 1 hour after a meal. Take all of the tablets for your daily dose at one time each day; do not divide the tablets to take as separate doses. Take lapatinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lapatinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Capecitabine is taken in combination with lapatinib, but on a different schedule. Be sure that you understand how and when to take capecitabine. Talk to your doctor and pharmacist if you have any questions about taking capecitabine.
Swallow the tablets whole; do not split, chew, or crush them.
Your doctor may gradually increase or decrease your dose of lapatinib during your treatment. This depends on how well the medication works for you and any side effects you may experience. Continue to take lapatinib even if you feel well. Do not stop taking lapatinib without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking lapatinib,
- tell your doctor and pharmacist if you are allergic to lapatinib, any other medications, or any of the ingredients in lapatinib tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: certain antibiotics such as clarithromycin (Biaxin, in Prevpac), erythromycin (E.E.S., E-Mycin, Erythrocin), moxifloxacin (Avelox), rifabutin (Mycobutin), rifampin (Rifadin, in Rifamate, in Rifater, Rimactane), rifapentine (Priftin), sparfloxacin (Zagam) (not available in the U.S.), and telithromycin (Ketek); antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); calcium channel blockers such as amlodipine (Norvasc, in Caduet and Lotrel), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil, in Lexxel), nifedipine (Adalat, Nifedical XL, Procardia, others), nisoldipine (Sular), and verapamil (Calan, Isoptin, Verelan, others); cisapride (Propulsid) (not available in the U.S.); dexamethasone (Decadron, Dexpak); certain medications for depression such as nefazodone; certain chemotherapy medications including daunorubicin (Cerubidine, DaunoXome), doxorubicin (Adriamycin, Doxil, Rubex), epirubicin (Ellence), idarubicin (Idamycin), tamoxifen (Nolvadex), valrubicin (Valstar), vinblastine, and vincristine; certain medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) including atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); medications for irregular heartbeat including amiodarone (Cordarone), disopyramide (Norpace), dofetilide (Tikosyn), procainamide (Procanbid), quinidine, and sotalol (Betapace, Betapace AF, Sorine); certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Tegretol), phenobarbital (Luminal), and phenytoin (Dilantin, Phenytek); pimozide (Orap); and thioridazine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with lapatinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- tell your doctor and pharmacist what herbal products you are taking, especially St. John's wort.
- tell your doctor if you have or have ever had a slow, fast, or irregular heartbeat; a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death); a low level of magnesium or potassium in your blood;or heart or lung disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are taking lapatinib. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking lapatinib, call your doctor immediately. Lapatinib may harm the fetus.
- you should know that lapatinib often causes diarrhea, which can be severe. Call your doctor if you have diarrhea while taking lapatinib. Your doctor may tell you to drink plenty of liquids, make changes in your diet, and take medication to control the diarrhea and prevent dehydration (loss of too much water from your body). Call your doctor immediately if you experience any of the following symptoms of dehydration: extreme thirst, dry mouth and/or skin, decreased urination, sunken eyes, or fast heartbeat.
What SPECIAL DIETARY instructions should I follow?
Do not eat grapefruit or drink grapefruit juice while taking this medication.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it that day. However, if you do not remember until the next day, if you cannot remember whether you took the medication, or if you vomit your medication, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Lapatinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- sores on the lips, mouth, or throat
- loss of appetite
- red, painful, numb, or tingling hands and feet
- dry skin
- pain in the arms, legs, or back
- difficulty falling asleep or staying asleep
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section or the SPECIAL PRECAUTIONS section, call your doctor immediately:
- shortness of breath
- dry cough
- coughing up pink or bloody mucus
- fast, irregular, or pounding heartbeat
- swelling of the hands, feet, ankles, or lower legs
Lapatinib may change the way your heart beats and pumps blood through your body. Your doctor will monitor you carefully to see whether lapatinib has affected your heart. Talk to your doctor about the risks of taking lapatinib.
Lapatinib may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
What OTHER INFORMATION should I know?
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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