Bosutinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat chronic myeloid leukemia. Take it exactly as directed.
• You may get infections or bleed more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious stomach or liver problems, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); kinase inhibitor

Generic and brand names: bosutinib, oral; Bosulif

What is this medicine used for?

This medicine is taken by mouth to treat chronic myeloid leukemia (CML), a cancer of the bone marrow, in people who do not respond to or cannot tolerate other treatment.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bleeding problems or blood disorders such as anemia (low red blood cells) or thrombocytopenia (low platelet cells)
• Edema (fluid buildup)
• Heart problems
• Liver or kidney disease

This medicine may make you sterile (unable to have children) whether you are a man or a woman. If you plan to have children someday, talk with your healthcare provider before you start treatment.

Females of childbearing age: This medicine is not given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. You must use effective birth control while you are taking this medicine and for 30 days after you stop taking this medicine. Talk with your healthcare provider about effective forms of birth control. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Treatment will be continued for as long as you continue to benefit and can tolerate the side effects. Your healthcare provider may adjust your dose depending on how you respond to this medicine. Follow your healthcare provider's instructions carefully.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine once per day with food. Taking it with meals and with a large glass of water may lessen the chance the drug will upset your stomach.

Swallow the tablets whole. Do not break, crush, or chew the tablets. Do not touch or handle crushed or broken tablets.

This medicine needs stomach acid to work best. Do not take medicines that reduce stomach acid such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), and pantoprazole (Protonix) while taking this medicine. Take antacids or famotidine (Pepcid), nizatidine (Axid), or ranitidine (Zantac) at least 2 hours before or 2 hours after you take this medicine. Talk with your healthcare provider or pharmacist about this.

What if I miss a dose?

Do not miss doses. If you do miss a dose, take it as soon as you remember that day. If it has been more than 12 hours since your last dose, skip the missed dose and take your next dose at your regular time. Do not take a double dose the next day. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: unusual bruising or bleeding.

What should I watch out for?

You need to have blood tests regularly to see how this medicine affects you. Keep all appointments for tests.

This medicine can cause fluid buildup (edema) or severe liver problems. If you notice shortness of breath, unusual tiredness, swelling of your hands or feet, or any unexplained swelling, yellowing of your eyes or skin, dark urine, or light-colored bowel movements, contact your healthcare provider right away.

This medicine may also cause severe stomach problems. Contact your healthcare provider right away if you have severe or ongoing nausea, vomiting, diarrhea, or stomach pain. Talk with your healthcare provider about this and how to manage these side effects.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

You may bleed more easily or get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Tell your healthcare provider if you have any unusual bruising or bleeding, or symptoms of an infection such as fever, sore throat, or cough. Also, do not have any vaccines without getting your healthcare provider's approval first.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe or continued stomach pain, diarrhea, nausea, or vomiting; unexplained swelling or weight gain, unusual bruising or bleeding, blood in your urine or bowel movements, black or tarry bowel movements, fever, unexplained cough, sore throat, shortness of breath, chest pain, fast or irregular heartbeat, severe confusion, unusual tiredness or weakness, yellowing of your skin or eyes, dark urine, light colored bowel movements, unexplained loss of appetite, trouble urinating, decreased urination.

Other: Mild nausea, vomiting, or diarrhea; stomach cramps; tiredness; loss of appetite; joint or muscle pain; headache; dizziness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Anagrelide (Agrylin)
• Antacids (Take antacids at least 2 hours before or 2 hours after you take this medicine.)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), nafcillin, pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), nefazodone, and sertraline (Zoloft)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ledipasvir/sofosbuvir (Harvoni) and simeprevir (Olysio)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), bicalutamide (Casodex), ceritinib (Zykadia), crizotinib (Xalkori), enzalutamide (Xtandi), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), sunitinib (Sutent), tamoxifen, toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), lomitapide (Juxtapid), lovastatin (Altoprev), pravastatin (Pravachol), and simvastatin (Zocor)
• Conivaptan (Vaprisol)
• Dexamethasone
• Dipyridamole (Persantine)
• Eliglustat (Cerdelga)
• Heart medicines such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), nicardipine (Cardene), procainamide, quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Ivacaftor (Kalydeco)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), dexlansoprazole (Dexilant), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec), pantoprazole (Protonix), rabeprazole (AcipHex), and ranitidine (Zantac) (Take these medicines at least 2 hours before or after you take this medicine.)
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Mirabegron (Myrbetriq)
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), ondansetron (Zofran), prochlorperazine (Compro), and promethazine
• Propranolol (Hemangeol, Inderal, InnoPran)
• St. John's wort
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Tetrabenazine (Xenazine)
• Vaccines

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

Do not have any vaccines without getting your healthcare provider's approval first.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.