Bosutinib tablets

What is this medication?

BOSUTINIB (boe SUE ti nib) is medicine that targets proteins in cancer cells and stops the cancer cell from growing. It is used to treat chronic myelogenous leukemia.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): BOSULIF

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• diabetes (high blood sugar)
• heart disease
• high blood pressure
• kidney disease
• liver disease
• an unusual or allergic reaction to bosutinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Do not cut, crush, or chew this medicine. Do not take with grapefruit juice. Avoid taking H2 blockers or antacids within 2 hours of taking this medicine. It is best to separate these medicines by 2 hours. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

This medicine may interact with the following:

• amprenavir
• antacids
• aprepitant
• atazanavir
• boceprevir
• certain medications for bacterial infections like ciprofloxacin, clarithromycin, erythromycin, and telithromycin
• certain medications for fungal infections like fluconazole, ketoconazole, itraconazole, posaconazole, and voriconazole
• certain medications for seizures like carbamazepine, phenobarbital, and phenytoin
• certain medications for stomach problems like cimetidine, famotidine, ranitidine, esomeprazole, dexlansoprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole
• conivaptan
• crizotinib
• darunavir
• diltiazem
• fosamprevir
• grapefruit juice
• imatinib
• indinavir
• nefazodone
• nelfinavir
• rifampin
• ritonavir
• saquinavir
• St. John's Wort
• telaprevir
• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

You may need blood work done while you are taking this medicine.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Do not become pregnant while taking this medicine or for at least 2 weeks after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for at least 2 weeks after the last dose.

This medicine may interfere with the ability to have a child. Talk with your doctor or health care professional if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash; itching or hives; swelling of the face, lips, or tongue)
• back pain
• bloody or black, tarry stools
• diarrhea
• dizziness
• headache
• heart attack (trouble breathing; pain or tightness in the chest, neck, back, or arms)
• heart failure (trouble breathing; fast, irregular heartbeat; sudden weight gain; swelling of the ankle, feet, hands)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• joint pain
• kidney injury (change in the amount of urine)
• light-colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite; right upper belly pain; yellowing of the eyes or skin)
• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)
• nausea
• red or dark brown urine
• stomach pain
• unusual bleeding or bruising
• unusual swelling
• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.