Dasatinib Oral tablet

What is this medicine?

DASATINIB (da SA ti nib) is a medicine that targets specific proteins in cancer cells and stops the cancer cells from growing. It is used to treat some kinds of leukemia.

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

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

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

• bleeding problems

• heart disease

• immune system problems

• irregular heartbeat

• liver disease

• low levels of magnesium or potassium in the blood

• an unusual or allergic reaction to dasatinib, lactose, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. Do not take with grapefruit juice. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Avoid taking antacids containing aluminum, calcium, or magnesium within 2 hours of taking this medicine. You can take such antacids up to 2 hours before or 2 hours after this medicine. Avoid taking all other medicines that reduce stomach acid.

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 your next scheduled dose at its regular time. Do not take double or extra doses. Talk to your doctor if you are not sure what to do.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• certain medicines for stomach problems like cimetidine, famotidine, ranitidine, omeprazole

• cisapride

• dofetilide

• dronedarone

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• pimozide

• St. John's Wort

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• acetaminophen

• alfentanil

• antiviral medicines for HIV or AIDS

• aspirin

• carbamazepine

• certain antibiotics like clarithromycin, erythromycin, rifampin, rifabutin, rifapentine, telithromycin, troleandomycin

• certain medicines for cholesterol like atorvastatin

• certain medicines that treat or prevent blood clots like warfarin

• cyclosporine

• dexamethasone

• fentanyl

• NSAIDS, medicines for pain and inflammation, like ibuprofen, ketoprofen, naproxen

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• phenobarbital

• phenytoin

• sirolimus

• tacrolimus

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 medicine?

Visit your doctor for regular check ups. Report any side effects. Continue your course of treatment unless your doctor tells you to stop. You will need blood work done while you are taking this medicine.

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

Do not become pregnant while taking this medicine or for 30 days 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 and for 2 weeks after the last dose.

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

• 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.

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

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

• signs of decreased red blood cells - unusual weakness or tiredness, fainting spells, lightheadedness

• breathing problems

• dry cough

• fast, irregular heartbeat

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• swelling of the legs or ankles, or other parts of the body

• sores or white patches in your mouth or throat

• sudden weight gain

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

• diarrhea

• headache

• nausea, vomiting

• weak or tired

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 medicine?

Keep out of the reach of children.

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

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.