Generic Name: bosutinib (boe SUE tin ib)
Brand Names: Bosulif

What is Bosulif?

Bosulif (bosutinib) interferes with the growth of some cancer cells.

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

Bosulif is usually given after other similar medications have been tried without success.

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

Important information

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

Do not use Bosulif if you are pregnant or breast-feeding a baby.

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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.

Before taking this medicine

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:

  • liver disease;

  • kidney disease;

  • heart disease;

  • epilepsy, migraine headaches; or

  • asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder.

FDA pregnancy category D. Do not use Bosulif if you are pregnant. It could harm the unborn baby. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication and for at least 30 days after your treatment ends.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether bosutinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine. After you stop taking Bosulif, ask your doctor how long to wait before breast-feeding again.

How should I take Bosulif?

Bosulif is usually taken once per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take 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. If this occurs, wash your skin with soap and water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet.

You may need frequent medical tests at your doctor's office to be sure Bosulif is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

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

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid?

Grapefruit and grapefruit juice may interact with Bosulif and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Bosulif side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Bosulif: hives; 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;

  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  • pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

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

  • swelling in your hands or feet, rapid weight gain;

  • pain in your chest, on your left side, or behind your breastbone;

  • pain when you breathe, fast or uneven heart rate, feeling short of breath (especially when lying down);

  • anxiety, sweating, wheezing, gasping for breath, cough with foamy mucus; or

  • feeling weak, tired, dizzy, or light-headed.

Common Bosulif side effects may include:

  • headache, dizziness, tired feeling;

  • mild stomach discomfort;

  • joint pain, back pain;

  • mild itching or rash; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

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.

See also: Side effects (in more detail)

What other drugs will affect Bosulif?

Many drugs can interact with Bosulif. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Bosulif, especially:

  • aprepitant;

  • bosentan;

  • cimetidine;

  • conivaptan;

  • cyclosporine;

  • digoxin, digitalis;

  • haloperidol;

  • imatinib;

  • modafinil;

  • St. John's wort;

  • an antibiotic--azithromycin, ciprofloxacin, clarithromycin, doxycycline, erythromycin, metronidazole, nafcillin, norfloxacin, rifabutin, rifampin, rifapentine, telithromycin, tetracycline;

  • antifungal medication--clotrimazole, fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole;

  • an antidepressant--desipramine, nefazodone, sertraline;

  • heart or blood pressure medication--amiodarone, captopril, carvedilol, diltiazem, dronedarone, felodipine, lidocaine, ranolazine, nicardipine, quinidine, verapamil;

  • hepatitis C medications--boceprevir, telaprevir;

  • HIV/AIDS medication--atazanavir, delavirdine, fosamprenavir, efavirenz, darunavir/ritonavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir;

  • seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; or

  • stomach acid reducers--dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole.

This list is not complete and many other drugs can interact with Bosulif. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Bosulif.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Bosulif only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2015 Cerner Multum, Inc. Version: 1.02. Revision Date: 2013-03-06, 2:56:17 PM.