Dasatinib

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) as a first treatment and in adults 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 1 year of age or older. Dasatinib is also used to treat a certain type of acute lymphoblastic leukemia (ALL; a type of cancer of the white blood cells) in adults who can no longer benefit from other leukemia medications or who cannot take these medications because of side effects. It is also used in combination with chemotherapy medications to treat a certain type of ALL in children 1 year of age or older.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.

Are there OTHER USES for this medicine?

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

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 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. If you cannot swallow the tablets whole or if you are giving this medication to a child, ask your doctor how to take dasatinib tablets. 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 temporarily or permanently stop your treatment with 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.

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. 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.

• the following nonprescription or herbal products may interact with dasatinib: cimetidine (Tagamet HB), famotidine (Pepcid AC), esomeprazole (Nexium 24HR), lansoprazole (Prevacid 24 HR), nizatidine (Axid AR), omeprazole (Prilosec OTC, Zegerid OTC), ranitidine, or St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking dasatinib. Do not start any of these medications while taking dasatinib without discussing with your healthcare provider.

• tell your doctor if you anyone in your family has or has ever had a prolonged QT interval (a rare heart condition that may cause irregular heartbeat, dizziness, fainting, or sudden death). Also, 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; problems with your immune system; or liver, lung, or heart disease.

• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You should not become pregnant while you are taking dasatinib and for 30 days after your final dose. If you are male, you and your female partner should use effective birth control while you are receiving pemetrexed injection and for 30 days after your final dose. 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. Women who are pregnant should not handle crushed or broken dasatinib tablets. Dasatinib may harm the fetus.

• tell your doctor if you are breastfeeding or plan to breastfeed.You should 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.

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?

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

• muscle, joint, or bone pain
• weakness
• headache
• pain, burning or tingling in the hands or the feet
• rash
• 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
• shortness of breath
• coughing up pink or bloody mucus
• dry cough
• chest pain or pressure
• dizziness
• fainting
• rapid, irregular, or pounding heartbeat
• unusual tiredness or weakness
• confusion
• temporary breast enlargement (in children)
• unusual bruising or bleeding; black, tarry, or bloody stools; or vomiting or spitting up blood or brown material that resembles coffee grounds
• vision changes
• slow or difficult speech
• weakness or numbness of an arm or leg
• fever; sore mouth or throat; or blistering or peeling of your skin or in the mouth
• yellowing of the skin or eyes, dark urine, loss of appetite, fatigue, or pain or discomfort in right upper stomach area
• nausea, vomiting, weakness, shortness of breath, seizures, irregular heartbeat, or muscle cramps

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.

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).

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.

What should I do in case of OVERDOSE?

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.

Symptoms of overdose may include the following:

• unusual bruising or bleeding
• fever, sore throat, chills, and/or 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 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.