Bosulif

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

Bosulif 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.

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

Do NOT use Bosulif if:

  • you are allergic to any ingredient in Bosulif
  • 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 Bosulif:

Some medical conditions may interact with Bosulif. 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 Bosulif. 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 Bosulif'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 Bosulif's effectiveness
  • Digoxin because the risk of its side effects may be increased by Bosulif

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bosulif 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 Bosulif:

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

  • An extra patient leaflet is available with Bosulif. Talk to your pharmacist if you have questions about this information.
  • Take Bosulif by mouth with food.
  • Swallow Bosulif 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 Bosulif.
  • Take Bosulif 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 Bosulif. Check with your doctor if you have questions.
  • Check with your doctor to see if you should drink extra fluids while you are taking Bosulif.
  • Continue to take Bosulif even if you feel well. Do not miss any doses.
  • If you miss a dose of Bosulif, 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 Bosulif.

Important safety information:

  • Bosulif may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Bosulif 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 Bosulif without checking with your doctor.
  • Tell your doctor or dentist that you take Bosulif before you receive any medical or dental care, emergency care, or surgery.
  • Bosulif 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.
  • Bosulif 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 Bosulif. Talk with your doctor before you receive any vaccine.
  • Bosulif 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 Bosulif 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 Bosulif. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Bosulif 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: Bosulif 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 Bosulif while you are pregnant. It is not known if Bosulif is found in breast milk. Do not breast-feed while taking Bosulif.

Possible side effects of Bosulif:

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 Bosulif:

Store Bosulif 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 Bosulif out of the reach of children and away from pets.

General information:

  • If you have any questions about Bosulif, please talk with your doctor, pharmacist, or other health care provider.
  • Bosulif 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 Bosulif 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 Bosulif. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Bosulif. 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 Bosulif.

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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