Sprycel (Dasatinib)

(da sa' ti nib)

Dasatinib is used to treat a certain type of chronic myeloid leukemia (CML; a type of cancer of the white blood cells) as a first treatment and in people who can no longer benefit from other leukemia medications including imatinib (Gleevec) or in those who cannot take these medications because of side effects. Dasatinib is also used to treat a certain type of chronic CML in children. 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 leukemia medications 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.

Dasatinib comes as a tablet to take by mouth. It is usually taken once a day, in the morning or in 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. Wear latex or nitrile gloves when handling tablets that are accidently crushed or broken to prevent contact with the medication. Your doctor may adjust your dose or permanently stop your treatment 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.

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: anticoagulants (''blood thinners'') such as warfarin (Coumadin, Jantoven); anthracycline medications for cancer such as daunorubicin (Cerubidine), doxorubicin (Doxil), and epirubicin (Ellence); certain antifungals such as ketoconazole (Nizoral), itraconazole (Onmel, Sporanox), and voriconazole (Vfend); clarithromycin (Biaxin, in PrevPac); dexamethasone; 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 (Nexterone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Tambocor), mexiletine (Mexitil), procainamide, propafenone (Rythmol), quinidine (in Nuedexta), and sotalol (Betapace, Betapace AF, Sorine), 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); nefazodone; rifampin (Rimactane, Rifadin, in Rifater, in Rifamate); and telithromycin (Ketek); Many 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 or plan to become pregnant. You should not become pregnant while you are taking dasatinib and for 30 days after your final dose. 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.
• do not breastfeed while taking dasatinib and for 2 weeks after your final dose.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking dasatinib.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking dasatinib.

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

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:

• muscle pain
• weakness
• joint pain
• pain, burning or tingling in the hands or the feet
• 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 or get emergency medical treatment:

• fever, sore throat, chills, and/or 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 becomes worse when coughing, sneezing, or breathing deeply
• chest pressure
• dizziness
• fainting
• rapid, irregular, or pounding heartbeat
• headache
• tiredness
• confusion
• temporary breast enlargement (in children)
• 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

Dasatinib may cause slowed growth or bone pain in children. Your child's doctor will monitor your child's development carefully while he or she is taking dasatinib. Talk to your doctor about the risks of giving this medication to your child. 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). It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment 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.