Brand Name(s):

• Sprycel®

WHY is this medicine prescribed?

Dasatinib is used to treat a certain type of chronic myeloid leukemia (CML; a type of cancer of the white blood cells), including treatment in people who can no longer benefit from other medications for leukemia including imatinib (Gleevec) or who cannot take these medications because of side effects. Dasatinib is also used to treat a certain type of acute lymphoblastic leukemia (ALL; a type of cancer of the white blood cells) in people who can no longer benefit from other medications for leukemia or who cannot take these medications because of side effects. Dasatinib is in a class of medications called 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.

HOW should this medicine be used?

Dasatinib comes as a tablet to take by mouth. It is usually taken once a day, in the morning or the evening, with or without food. Take dasatinib at around the same time 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.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

Before taking dasatinib,

• tell your doctor and pharmacist if you are allergic to dasatinib, any other medications, or any of the ingredients in dasatinib tablets. Ask your pharmacist for a list of the ingredients.
• 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, Jantoven); anthracycline medications for cancer such as daunorubicin (Cerubidine), doxorubicin (Doxil), and epirubicin (Ellence); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Anaprox, Naprelan); certain antifungals such as ketoconazole (Nizoral), itraconazole (Sporanox), and voriconazole (Vfend); cisapride (Propulsid) (not available in the United States); clarithromycin (Biaxin, in PrevPac); dexamethasone (Decadron); cyclosporine (Gengraf, Neoral, 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); rifabutin (Mycobutin); rifampin (Rimactane, Rifadin, in Rifater, in Rifamate); simvastatin (in Simcor, in Vytorin, Zocor); sirolimus (Rapamune), tacrolimus (Prograf); telithromycin (Ketek); 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), problems with your immune system, or liver, lung or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are taking dasatinib. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking dasatinib, call your doctor. Women who are pregnant should not handle crushed or broken dasatinib tablets. Dasatinib may harm the fetus.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking dasatinib.

What SPECIAL DIETARY instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while taking this medication..

What should I do IF I FORGET to take a dose?

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

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of 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.

What should I do in case of OVERDOSE?

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.

Symptoms of overdose may include:

• unusual bruising or bleeding
• fever, sore throat, chills, and other signs of infection
• shortness of breath
• fast heartbeat
• headache
• pale skin
• confusion
• tiredness

What OTHER INFORMATION should I know?

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.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: January 15, 2013.