When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to bosutinib, or if you are pregnant.

How to Use This Medicine:
Tablet

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not crush or break it, and do not handle broken tablets.
• It is best to take this medicine with food or milk.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. If you are more than 12 hours late in taking a dose, skip the missed dose and go back to your regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how bosutinib works. Tell your doctor if you are using the following:
  
  • Aprepitant, boceprevir, bosentan, conivaptan, crizotinib, diltiazem, imatinib, modafinil, nefazodone, St John's wort, telaprevir, verapamil
  • Blood pressure medicine
  • Medicine to treat an infection
  • Medicine to treat HIV infection
  • Medicine to treat seizures
• Ask your doctor which stomach medicines are safe for you to take. Wait at least 2 hours before or after you take bosutinib. Do not take a proton pump inhibitor (PPI).
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Keep using birth control for at least 30 days after your last dose of this medicine.
• Tell your doctor if you are breastfeeding, or if you have liver disease, kidney disease, or heart disease.
• This medicine may cause the following problems:
  
  • Liver problems
  • Kidney problems
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe diarrhea, nausea, vomiting, stomach pain
• Trouble breathing, chest pain, cough
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088