Bosutinib tablets

What is this medicine?

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.

How should I use this medicine?

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.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• back pain

• breathing problems

• chest pain or chest tightness

• cough

• diarrhea

• dizziness

• joint pain

• loss of appetite

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• nausea, vomiting

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

• signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• stomach pain

• swelling of the ankles, feet, hands

• weight gain

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

• vomiting

• headache

What may interact with this medicine?

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

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.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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

• heart disease

• 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

What should I watch for while using this medicine?

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.