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

Bosutinib is usually given after other treatments have failed.

Bosutinib may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Bosutinib 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.

Bosutinib 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 bosutinib 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 bosutinib if you are allergic to it.

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 bosutinib, 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.

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.

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

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: hives, itching; dizziness; back pain, joint pain; difficult breathing; swelling of your face, lips, tongue, or throat.

Bosutinib may cause serious side effects. Stop using bosutinib 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 side effects of bosutinib 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 bosutinib much less effective when taken at the same time. If you take an antacid or stomach acid reducer (Zantac, Prilosec, and others), take your bosutinib dose 2 hours before or 2 hours after you take the other medicine.

Many drugs can affect 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.

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.