Dasatinib is a cancer medicine that slows the growth and spread of cancer cells in the body.

Dasatinib is used in adults and children to treat a type of blood cancer called Philadelphia chromosome-positive chronic myelogenous leukemia (CML).

Dasatinib is also used to treat Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) in adults and children.

Dasatinib is a cancer medication that slows the growth and spread of cancer cells in the body.

Dasatinib can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

Some people using dasatinib have developed a rare but serious condition called pulmonary arterial hypertension (PAH). PAH may be irreversible if not promptly treated, and this condition can be fatal. Talk to your doctor about your specific risk of developing PAH.

Take dasatinib exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take dasatinib with or without food. Take the medicine at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it.

Do not take a tablet that has been accidentally broken. The medicine from a crushed or broken tablet can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Wear rubber gloves while handling a broken tablet or capsule. Ask your doctor or pharmacist how to safely dispose of the broken pill. A pregnant woman should not handle a broken pill.

Dasatinib can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Do not change your dose or stop using dasatinib without your doctor's advice.

Store at room temperature away from moisture and heat.

Usual Adult Dose of Dasatinib for Leukemia:

Chronic Phase CML: 100 mg orally once a day
Accelerated Phase CML, Myeloid or Lymphoid Blast Phase CML, Ph+ ALL: 140 mg orally once a day

Comments:
-Treatment should be continued until disease progression or unacceptable toxicity.
-The effect of discontinuing therapy after complete cytogenetic response is achieved has not been investigated.

Uses:
-For the treatment of adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
-For the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
-For the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy

Usual Pediatric Dose of Dasatinib for Leukemia:

Body weight of 10 kg to less than 20 kg: 40 mg orally once a day
Body weight of 20 kg to less than 30 kg: 60 mg orally once a day
Body weight of 30 kg to less than 45 kg: 70 mg orally once a day
Body weight of at least 45 kg: 100 mg orally once a day

Comments:
-The recommended starting dosage is based on body weight.
-The dose should be recalculated every 3 months or more often based on body weight changes.
-Patients with Ph+ ALL, start therapy on or before day 15 of induction chemotherapy, when diagnosis is confirmed and continue for 2 years.
-Tablet dosing is not recommended for patients weighing less than 10 kg.

Uses:
-For the treatment of Ph+ CML in chronic phase
-For the treatment of newly diagnosed Ph+ ALL in combination with chemotherapy

Some people using dasatinib have developed a rare but serious condition called pulmonary arterial hypertension (PAH). PAH occurs when blood pressure increases inside the arteries in your lungs. This makes it harder for your heart to pump blood through the lungs, which also weakens muscles in the heart. PAH may be irreversible if not promptly treated, and this condition can be fatal. Talk to your doctor about your specific risk of developing PAH.

To make sure dasatinib is safe for you, tell your doctor if you have ever had:

• a weak immune system (caused by disease or by using certain medicines);

• stomach or intestinal bleeding;

• liver disease;

• heart disease;

• low levels of potassium or magnesium in your blood;

• long QT syndrome (in you or a family member);

• lung disease; or

• lactose intolerance.

Dasatinib may harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using dasatinib and for at least 30 days after your last dose. Tell your doctor if you become pregnant.

Pregnancy may be less likely to occur while the mother or the father is using dasatinib. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

You should not breastfeed while taking dasatinib and for at least 2 weeks after your last dose.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

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

Grapefruit may interact with dasatinib and cause side effects. Avoid consuming grapefruit products while taking this medicine.

Avoid taking an antacid within 2 hours before or after you take dasatinib. Some antacids can make it harder for your body to absorb dasatinib.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Get emergency medical help if you have signs of an allergic reaction to dasatinib (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor right away if you have any symptoms of pulmonary arterial hypertension (PAH), such as:

• chest pain, feeling tired or short of breath (even with mild exertion);

• swelling in your feet, lower legs, or midsection;

• blue-colored lips and skin; and

• a light-headed feeling, like you might pass out.

Also call your doctor at once if you have:

• severe ongoing nausea, vomiting, or diarrhea;

• severe headaches, extreme tiredness, muscle or joint pain;

• pain when you breathe, shortness of breath (especially when lying down);

• swelling, rapid weight gain;

• chest pain, shortness of breath, pounding heartbeats or fluttering in your chest, vision problems or slurred speech;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), pinpoint purple or red spots under your skin;

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• other signs of bleeding - blood in your urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds, confusion, headache, problems with speech;

• low blood cell counts - fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, pale skin, cold hands and feet, feeling light-headed; or

• signs of tumor cell breakdown - tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Dasatinib may affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common dasatinib side effects may include:

• nausea, diarrhea, stomach pain;

• headache, muscle pain, pain in your hands or feet;

• breathing problems;

• skin rash; or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Dasatinib may increase your risk of severe or fatal bleeding, especially if you also use a blood thinner or any medication to prevent blood clots.

Many drugs can interact with dasatinib, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

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.