Bosulif (Bosutinib Monohydrate)

(boe sue' ti nib)

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 have been recently found to have this condition and in those 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 temporarily or permanently stop your treatment or adjust your dose of bosutinib depending on your response to treatment and any 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.

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: certain antifungals such as ketoconazole and itraconazole (Sporanox); aprepitant (Emend); certain medications used to treat human immunodeficiency virus (HIV) such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); medications to reduce stomach acid (proton-pump inhibitors) such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (AcipHex); diltiazem (Cardizem, Cartia, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); nefazodone; rifabutin (Mycobutin); and rifampin (Rifadin, Rimactane in Rifamate, in Rifater). 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 kidney, liver, or heart disease.
• tell your doctor if you are pregnant or plan to become pregnant. You will need to take a pregnancy test before you start treatment and 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 2 weeks after your final dose. 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 breastfeeding. You should not breastfeed while you are taking bosutinib and for 2 weeks after your last dose.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking bosutinib.

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

Take the missed dose with food 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

• 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
• change in the frequency of urination
• increase or decrease in the amount of urine
• 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.

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). It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call 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.