Bosulif interferes with the growth of some cancer cells.

Bosulif is used in adults to treat a type of blood cancer called Philadelphia chromosome-positive chronic myelogenous leukemia (CML).

Bosulif is usually given after other treatments have failed.

Do not use Bosulif if you are pregnant or breastfeeding a baby.

Take Bosulif with food.

Do not break or crush a Bosulif tablet. The medicine from a crushed or broken pill can be dangerous if it gets on your skin. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet.

Stop using Bosulif and call your doctor at once if you have fever, easy bruising or bleeding, shortness of breath, jaundice (yellowing of the skin or eyes), swelling or rapid weight gain, blood in your stools, or severe and ongoing vomiting, stomach pain, or diarrhea.

Bosulif is usually taken once per day. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take with food.

Swallow the tablet whole and do not crush, chew, or break it. The medicine from a crushed or broken pill can be dangerous if it gets on your skin. If this happens, wash your skin with soap and water. Ask your pharmacist how to safely dispose of a broken pill.

Bosulif can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

You should not stop using Bosulif without your doctor's advice.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Chronic Myelogenous Leukemia:

Newly-diagnosed:
400 mg orally once daily
Duration of therapy: Until disease progression or patient intolerance

Chronic/accelerated/blast phase:
500 mg orally once daily
Duration of therapy: Until disease progression or patient intolerance

Comments:
-Take this drug with food.
-If a dose is missed beyond 12 hours, the patient should skip the dose and take the usual prescribed dose on the following day.

Uses:
-For newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)
-For chronic phase, accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy

You should not use Bosulif if you are allergic to bosutinib.

To make sure Bosulif is safe for you, tell your doctor if you have ever had:

• heart disease;

• liver disease; or

• kidney disease.

You may need to have a negative pregnancy test before starting this treatment.

Bosutinib may harm an unborn baby. Use effective birth control while you are using this medicine, and for at least 2 weeks after your last dose. Tell your doctor right away if you become pregnant.

You should not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with bosutinib and lead to unwanted side effects. Avoid the use of grapefruit products.

Get emergency medical help if you have signs of an allergic reaction to Bosulif: hives, itching; dizziness; back pain, joint pain; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Bosulif and call your doctor at once if you have:

• severe or ongoing nausea, vomiting, stomach pain, or diarrhea;

• blood in your stools;

• urinating more or less than usual;

• feeling light-headed or short of breath;

• heart problems - swelling, rapid weight gain, feeling short of breath;

• low blood cell counts - fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet;

• liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• swelling or fluid build-up in the lungs - anxiety, sweating, pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Bosulif side effects may include:

• headache, feeling tired;

• nausea, vomiting, diarrhea, stomach pain;

• fever, cough;

• abnormal liver function tests;

• swelling;

• rash; or

• low blood cell counts.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Some medicines can make Bosulif much less effective when taken at the same time. If you take an antacid or stomach acid reducer (Zantac, Prilosec, and others), take your Bosulif dose 2 hours before or 2 hours after you take the other medicine.

Many drugs can interact with bosutinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.