Bosutinib

Generic Name: bosutinib (boe-SUE-ti-nib)
Brand Name: Bosulif

Bosutinib is used for:

Treating a certain type of leukemia called Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in certain patients. It may also be used for other conditions as determined by your doctor.

Bosutinib is a kinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use bosutinib if:

  • you are allergic to any ingredient in bosutinib
  • you are taking aprepitant, certain azole antifungals (eg, fluconazole, ketoconazole, itraconazole, voriconazole), bosentan, carbamazepine, ciprofloxacin, clarithromycin, cobicistat, conivaptan, crizotinib, dexamethasone, diltiazem, efavirenz, enzalutamide, erythromycin, etravirine, felbamate, fosaprepitant, griseofulvin, hydantoins (eg, phenytoin), imatinib, mifepristone, modafinil, nafcillin, nefazodone, nevirapine, oxcarbazepine, phenobarbital, primidone, protease inhibitors (eg, boceprevir, ritonavir), rifamycins (eg, rifampin), St. John's wort, telithromycin, topiramate, or verapamil

Contact your doctor or health care provider right away if any of these apply to you.

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Before using bosutinib:

Some medical conditions may interact with bosutinib. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of heart problems (eg, congestive heart failure), liver problems, or lung problems
  • if you have bone marrow problems, low white blood cell levels, low blood platelet levels, or anemia
  • if you have a history of swelling (edema) or fluid retention

Some MEDICINES MAY INTERACT with bosutinib. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Aprepitant, azole antifungals (eg, fluconazole, ketoconazole, itraconazole, voriconazole), ciprofloxacin, cobicistat, conivaptan, crizotinib, diltiazem, fosaprepitant, imatinib, macrolide antibiotics (eg, clarithromycin, erythromycin), mifepristone, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), telithromycin, or verapamil because they may increase the risk of bosutinib's side effects
  • Bosentan, carbamazepine, dexamethasone, efavirenz, enzalutamide, etravirine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nafcillin, nevirapine, oxcarbazepine, phenobarbital, primidone, proton pump inhibitors (PPIs) (eg, omeprazole), rifamycins (eg, rifampin), St. John's wort, or topiramate because they may decrease bosutinib's effectiveness
  • Digoxin because the risk of its side effects may be increased by bosutinib

This may not be a complete list of all interactions that may occur. Ask your health care provider if bosutinib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use bosutinib:

Use bosutinib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with bosutinib. Talk to your pharmacist if you have questions about this information.
  • Take bosutinib by mouth with food.
  • Swallow bosutinib whole. Do not break, crush, cut, or chew before swallowing.
  • Do not touch or handle crushed or broken tablets.
  • Do not eat grapefruit or drink grapefruit juice while you use bosutinib.
  • Take bosutinib on a regular schedule to get the most benefit from it.
  • If you also take an H2 receptor antagonist (eg, ranitidine) or an antacid, do not take it within 2 hours before or after taking bosutinib. Check with your doctor if you have questions.
  • Check with your doctor to see if you should drink extra fluids while you are taking bosutinib.
  • Continue to take bosutinib even if you feel well. Do not miss any doses.
  • If you miss a dose of bosutinib, take it as soon as you remember. If it has been more than 12 hours since your last dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use bosutinib.

Important safety information:

  • Bosutinib may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use bosutinib with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT take more than the recommended dose, change your dose, or stop taking bosutinib without checking with your doctor.
  • Tell your doctor or dentist that you take bosutinib before you receive any medical or dental care, emergency care, or surgery.
  • Bosutinib may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Bosutinib may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking bosutinib. Talk with your doctor before you receive any vaccine.
  • Bosutinib may cause stomach pain, nausea, diarrhea, or vomiting. If you experience any of these problems, contact your doctor.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
  • Women who may become pregnant must use an effective form of birth control while taking bosutinib and for at least 30 days after stopping treatment. If you have questions about effective birth control, talk with your doctor.
  • Lab tests, including liver function and complete blood cell counts, may be performed while you use bosutinib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Bosutinib should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Bosutinib may cause harm to the fetus. Do not become pregnant while you are taking it and for at least 30 days after you stop taking it. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using bosutinib while you are pregnant. It is not known if bosutinib is found in breast milk. Do not breast-feed while taking bosutinib.

Possible side effects of bosutinib:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back or joint pain; decreased appetite; diarrhea; dizziness; headache; joint pain; mild stomach pain; nausea; nose or throat irritation; runny or stuffy nose; sneezing; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; fever, chills, or persistent sore throat; irregular heartbeat; severe or persistent dizziness, headache, tiredness, or weakness; severe or persistent stomach or back pain, diarrhea, nausea, or vomiting; shortness of breath or cough; sudden, unusual weight gain; swelling of the hands, ankles, feet, or other areas of your body; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, right-sided stomach pain, yellowing of the eyes or skin); unusual bruising or bleeding; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of bosutinib:

Store bosutinib at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep bosutinib out of the reach of children and away from pets.

General information:

  • If you have any questions about bosutinib, please talk with your doctor, pharmacist, or other health care provider.
  • Bosutinib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take bosutinib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about bosutinib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to bosutinib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using bosutinib.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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