Dasatinib

Notice:

Dasatinib is used to treat certain types of leukemia (cancer that begins in the white blood cells) in people who can no longer benefit from other medications for leukemia including imatinib (Gleevec) or who cannot take these medications because of severe side effects. Dasatinib is in a class of medications called protein-tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Dasatinib comes as a tablet to take by mouth. It is usually taken twice a day, in the morning and the evening, with or without food. Take dasatinib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dasatinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor may adjust your dose of dasatinib depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

Continue to take dasatinib even if you feel well. Do not stop taking dasatinib without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking dasatinib,

• tell your doctor and pharmacist if you are allergic to dasatinib or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: alfentanil (Alfenta), anticoagulants (''blood thinners'') such as warfarin (Coumadin), anthracycline medications for cancer such as daunorubicin (Cerubidine), doxorubicin (Doxil), and epirubicin (Ellence); aspirin; certain antifungals such as ketoconazole (Nizoral), and itraconazole (Sporanox); astemizole (Hismanal) (not available in the United States; cisapride (Propulsid) (not available in the United States); clarithromycin (Biaxin); dexamethasone (Decadron); cyclosporine (Sandimmune); ergot alkaloids such as ergotamine (Ergomar), and dihydroergotamine (D.H.E. 45, Migranal); erythromycin (E.E.S., E-Mycin, Erythrocin); fentanyl (Duragesic, Actiq); certain medications used to treat human immunodeficiency virus (HIV) such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); certain medications for irregular heartbeat such as amiodarone (Cordarone), disopyramide (Norpace),dofetilide (Tikosyn), flecainide (Tambocor), mexiletine (Mexitil), moricizine (Ethmozine), procainamide (Procanbid, Pronestyl), propafenone (Rythmol), quinidine (Quinidex), sotalol (Betapace, Betapace AF), and tocainide (Tonocard); medications to reduce stomach acid such as cimetidine (Tagamet^®), famotidine (Pepcid), nizatidine (Axid), ranitidine (Zantac), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (AcipHex); certain medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal), and phenytoin (Dilantin); moxifloxacin (Avelox); nefazodone; pimozide (Orap); rifampicin (Rimactane); simvastatin (Zocor); sirolimus (Rapamune), tacrolimus (Prograf); telithromycin (Ketek); terfenadine (Seldane) (not available in the United States); and thioridazine (Mellaril). Other medications may also interact with dasatinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking antacids, such as aluminum hydroxide/magnesium hydroxide (Maalox), calcium carbonate (Tums) or calcium carbonate and magnesium (Rolaids), take them 2 hours before or 2 hours after you take dasatinib.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have or have ever had lactose intolerance (inability to digest dairy products), low levels of potassium or magnesium in your blood, long QT syndrome (a heart condition that may cause dizziness, fainting, or irregular heartbeat), or liver or heart disease.
• tell your doctor if you are pregnant or plan to become pregnant, or if your partner may become pregnant. You or your partner should not become pregnant while you are taking dasatinib. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with dasatinib. Talk to your doctor about birth control methods that will work for you. If you or your partner becomes pregnant while taking dasatinib, call your doctor. Dasatinib may harm the fetus.
• tell your doctor if you are breast-feeding. You should not breast-feed while you are taking dasatinib.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Dasatinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache

• muscle pain

• tiredness

• weakness

• dizziness

• joint pain

• pain, burning or tingling in the hands or the feet

• skin rash

• skin redness

• peeling skin

• swelling, redness and pain inside the mouth

• mouth sores

• diarrhea

• nausea

• vomiting

• constipation

• stomach pain or swelling

• loss of appetite

• weight loss

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fever, sore throat, chills, and other signs of infection

• swelling of the eyes, hands, arms, feet, ankles or lower legs

• sudden weight gain

• difficulty breathing, especially when lying down

• coughing up pink or bloody mucus

• dry cough

• chest pain that gets worse when coughing, sneezing or breathing deeply

• chest pressure

• dizziness

• fainting

• rapid, irregular, or pounding heartbeat

• unusual bruising or bleeding

• black and tarry stools

• red blood in stools

• bloody vomit

• vomiting material that looks like coffee grounds

• slow or difficult speech

• weakness or numbness of an arm or leg

• sudden severe headache

Dasatinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to dasatinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Last Revised - 04/15/2012