Bosutinib

Bosutinib is used to treat a certain type of chronic myeloid leukemia (CML; a type of cancer of the white blood cells), including treatment in people who can no longer benefit from other medications for CML or who cannot take these medications because of side effects. Bosutinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Bosutinib comes as a tablet to take by mouth. It is usually taken with food once a day. Take bosutinib 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 bosutinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them. If any of the tablets are broken or crushed, do not touch them with your bare hands.

Your doctor may increase or decrease your dose of bosutinib during your treatment. This depends on how well the medication works for you and on the side effects that you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take bosutinib even if you feel well. Do not stop taking bosutinib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking bosutinib,

• tell your doctor and pharmacist if you are allergic to bosutinib or any of the ingredients in bosutinib tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antifungals such as fluconazole (Diflucan), ketoconazole (Nizoral), itraconazole (Sporanox), posaconazole (Noxafil), and voriconazole (Vfend); boceprevir (Victrelis); aprepitant (Emend); bosentan (Tracleer); certain medications used to treat human immunodeficiency virus (HIV) such as amprenavir (Agenerase), atazanavir (Reyataz), darunavir (Prezista), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); medications to reduce stomach acid such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (AcipHex); certain medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal), and phenytoin (Dilantin); ciprofloxacin (Cipro, Proquin XR); clarithromycin (Biaxin); digoxin (Digitek, Lanoxin); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); modafinil (Provigil); nafcillin (Unipen, Nallpen); nefazodone; rifabutin (Mycobutin); rifampin (Rimactane, Rifadin, in Rifater, in Rifamate); telaprevir (Incivek); telithromycin (Ketek); and verapamil (Calan, Isoptin, Verelan). Many other medications may also interact with bosutinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• if you are taking antacids, such as aluminum hydroxide/magnesium hydroxide (Maalox), calcium carbonate (Tums) or calcium carbonate and magnesium (Rolaids) or medications to reduce stomach acid, such as cimetidine (Tagamet), famotidine (Pepcid), or ranitidine (Zantac), take them 2 hours before or 2 hours after you take bosutinib.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have or have ever had liver or heart disease.
• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking bosutinib. You should use an effective form of birth control during treatment with bosutinib and for one month after treatment. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking bosutinib, call your doctor. Bosutinib may harm the fetus.
• tell your doctor if you are breast-feeding. You should not breast-feed while you are taking bosutinib.

Do not eat grapefruit, drink grapefruit juice, or take any supplement containing grapefruit extract while taking this medication.

Take the missed dose as soon as you remember it. However, if it has been more than 12 hours since your last dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Bosutinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache

• loss of appetite

• tiredness or weakness

• back, joint, limb, or muscle pain

• change in ability to taste food

• ringing in the ears

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• nausea

• vomiting

• diarrhea

• sudden stomach area pain

• unexplained bleeding or bruising

• blood in urine or stool

• dizziness

• fever, sore throat, chills, or other signs of infection

• shortness of breath and cough

• chest pain

• swelling of face, hands, ankles, feet, or lower legs

• sudden weight gain

• yellowing of the skin and eyes

• dark or tea-colored urine

• hives

• rash

• itching

• difficulty breathing or swallowing

Bosutinib may cause other side effects. Call your doctor if you have any unusual problems while 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 http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to bosutinib.

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.

Last Revised - 02/15/2013