DASATINIB

What is this medication?

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.

How should I use this medication?

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.

Dosing information

• 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.

What if I miss a 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.

How should I store this medication?

Store at room temperature away from moisture and heat.

What are the possible side effects of using this medication?

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.

What other drugs will affect dasatinib?

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.