Bosutinib (boe-SUE-ti-nib)

Treats leukemia.

Brand Name(s):

Bosulif

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Swallow the tablet whole. Do not Do not cut, crush, break, or chew it.
• Swallow the capsule whole. If you are unable to swallow the capsule whole:
  • Gather the supplies (including container, applesauce or yogurt, teaspoon, disposable gloves) needed to prepare the mixture.
  • Put on disposable gloves. Add the amount of room temperature applesauce or yogurt needed to the container. Do not use any other food.
  • Carefully open the capsule and mix the entire contents with applesauce or yogurt.
  • Swallow the mixture right away without chewing. Do not store the mixture for later use.
  • Throw away the empty capsule shell in the household thrash.
  • Wash the teaspoon and container with soap and warm water. Remove the gloves and throw them away in the household thrash. Wash and dry your hands.
• 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 miss dose and it is more than 12 hours , 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 medicines can affect how bosutinib works. Tell your doctor if you are using any of the following:
  • Aprepitant, ketoconazole, rifampin, St John's wort
  • Medicine to treat seizures
  • Stomach medicine (including lansoprazole)
• If you use an antacid or stomach medicine, take it at least 2 hours before or after you take this medicine.
• 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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant. Use an effective birth control to keep from getting pregnant during treatment with this medicine and for at least 2 weeks after your last dose.
• Do not breastfeed during treatment and for at least 2 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, fluid retention, heart disease, high blood pressure, or history of heart failure or diabetes.
• This medicine may cause the following problems:
  • Liver problems
  • Fluid retention (too much water in your body)
  • Kidney problems
  • Heart problems, including heart failure
• 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.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• 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
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe diarrhea, nausea, vomiting, stomach pain
• Trouble breathing, chest pain
• Unusual bleeding, bruising, or weakness

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

• Headache
• Mild diarrhea

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