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

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

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

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

Sprycel 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 Sprycel 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Some people using Sprycel 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 Sprycel 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 Sprycel 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 Sprycel. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

It is not known whether dasatinib passes into breast milk or if it could harm a nursing baby. You should not breastfeed while taking Sprycel and for at least 2 weeks after your last dose.

Take Sprycel exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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

Do not crush, chew, or break a Sprycel tablet. Swallow the tablet whole. If your child cannot swallow the tablet whole, talk with your healthcare provider.

Do not take a pill that has been accidentally broken. The medicine from a crushed or broken pill 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.

Sprycel 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 Sprycel without your doctor's advice.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Leukemia:

Chronic Phase CML:

100 mg orally once a day

Duration of therapy: Until disease progression or patient is intolerant.

Accelerated Phase CML, Myeloid or Lymphoid Blast Phase CML, Ph+ ALL:

140 mg orally once a day

Duration of therapy: Until disease progression or patient is intolerant

Comments:
-This drug should be used at the lowest effective dose in order to achieve therapeutic efficacy and minimize adverse effects.

-The effect of discontinuing therapy after complete cytogenetic response is achieved has not been investigated.

Uses: Chronic phase, accelerated phase, or myeloid or lymphoid blast phase Philadelphia chromosome-positive chronic myelogenous leukemia; Philadelphia chromosome-positive acute lymphoblastic leukemia

Some people using Sprycel 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 Sprycel 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 Sprycel 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 Sprycel. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

It is not known whether dasatinib passes into breast milk or if it could harm a nursing baby. You should not breastfeed while taking Sprycel 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.

Grapefruit and grapefruit juice may interact with dasatinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking Sprycel.

Avoid taking an antacid within 2 hours before or after you take Sprycel. 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.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Sprycel: (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.

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

Common Sprycel 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 use, which may increase side effects or make the medicines less effective.

Sprycel 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 together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.