INDICATIONS AND IMPORTANT SAFETY INFORMATION

What is DASATINIB?

DASATINIB is a prescription medicine used to treat:

• Adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP)
• Adults with Ph+ CML who no longer benefit from, or did not tolerate, other treatment, including imatinib
• Adults with Ph+ acute lymphoblastic leukemia (Ph+ ALL) who no longer benefit from, or did not tolerate, other treatment
• Children 1 year of age and older with Ph+ CML in chronic phase
• Children 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy

What should I discuss with my healthcare provider before starting DASATINIB?

Talk to your healthcare provider about all of your medical conditions, including if you have any of these medical conditions:

• problems with your immune system
• heart problems, including a condition called congenital long QT syndrome
• low potassium or low magnesium levels in your blood
• lactose (milk sugar) intolerance
• liver problems

Tell your healthcare provider if you are:

• Pregnant or plan to become pregnant. DASATINIB can harm your unborn baby.
  • Females who can become pregnant:
    • You should not become pregnant during treatment with DASATINIB.
    • You should use effective birth control (contraception) during treatment and for 30 days after your last dose of DASATINIB.
    • Talk to your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with DASATINIB.
  • Males with female partners who can become pregnant:
    • You should use effective birth control (contraception) during treatment and for 30 days after your last dose of DASATINIB.
    • Your female partner should call her healthcare provider if she becomes pregnant or thinks she is pregnant during your treatment with DASATINIB.
• Breastfeeding or plan to breastfeed. It is not known if DASATINIB passes into your breast milk. You should not breastfeed during treatment and for 2 weeks after your last dose of DASATINIB.

Females who are pregnant should not handle crushed or broken DASATINIB tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, antacids and herbal supplements

If you take an antacid medicine, take it 2 hours before or 2 hours after your dose of DASATINIB.

DASATINIB may interact with other medicines you are taking. This can change the relative effectiveness of DASATINIB or cause unwanted side effects.

During treatment with DASATINIB, make sure you also talk to your healthcare provider before you begin to take anything new. Your healthcare provider can help identify any potential interactions and help find alternatives.

How should DASATINIB be taken?

Take DASATINIB exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose of DASATINIB or temporarily stop treatment with DASATINIB. Do not change your dose or stop taking DASATINIB without first talking to your healthcare provider.

• Do take DASATINIB one (1) time a day
• Do take DASATINIB with or without food, either in the morning or in the evening, at the same time each day
• Do swallow DASATINIB tablets whole with water
• If your child cannot swallow tablets whole, talk to your healthcare provider
• Do not cut, crush, or chew the tablets
• Do not drink grapefruit juice during treatment with DASATINIB
• Do not take St. John's Wort during treatment with DASATINIB

What if I miss a dose of DASATINIB?

If you miss a dose of DASATINIB, take your next scheduled dose at your regular time. Do not take two doses at the same time. Call your healthcare provider or your pharmacist if you are not sure what to do.

What if I take too much DASATINIB?

Call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of DASATINIB^® (DASATINIB)?

Serious side effects

DASATINIB may cause serious side effects, including those listed below.

Call your healthcare provider right away if you have any symptoms of the side effects below, or any other concerns about these side effects:

• Low blood cell counts: Low blood cell counts are common with DASATINIB and can be severe, including low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Your healthcare provider will do blood tests to check your blood cell counts regularly during your treatment with DASATINIB. Call your healthcare provider right away if you have any of these symptoms during treatment with DASATINIB:
  • fever
  • any signs of an infection


• Bleeding problems: Bleeding problems are common with DASATINIB. Sometimes these bleeding problems can be serious and lead to death. Call your healthcare provider right away if you have:
  • unusual bleeding or bruising of your skin
  • bright red or dark tar-like stools
  • decreased alertness, headache, or change in speech


• Your body may hold too much fluid (fluid retention): Fluid retention is common with DASATINIB and can sometimes be severe. In severe cases, fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Call your healthcare provider right away if you have any of these symptoms during treatment with DASATINIB:
  • swelling all over your body
  • weight gain
  • shortness of breath, especially if this happens with low levels of physical activity or at rest
  • dry cough
  • chest pain when taking a deep breath


• Heart and blood vessel (cardiovascular) problems: DASATINIB may cause heart problems, including an abnormal heart rate, a heart attack, or small strokes that last only a few minutes or a few hours, called transient ischemic attacks (TIAs). TIAs are often a warning sign that you are at risk for a more serious stroke. Your healthcare provider will monitor the potassium and magnesium levels in your blood and your heart function.
  
  

  Get medical help right away if you develop any of the following symptoms during treatment with DASATINIB:

  • chest pain
  • shortness of breath
  • feeling like your heart is beating too fast or you feel abnormal heartbeats
  • vision changes that may last for a short time
  • slurred speech


• Pulmonary Arterial Hypertension (PAH): DASATINIB may cause high blood pressure in the vessels of your lungs. PAH may happen at any time during your treatment with DASATINIB. Your healthcare provider should check your heart and lungs before and during your treatment with DASATINIB. Call your healthcare provider right away if you have any of these symptoms:
  • shortness of breath
  • tiredness
  • swelling all over your body (fluid retention)


• Severe skin reactions: DASATINIB may cause skin reactions that can sometimes be severe. Get medical help right away if you have any of these symptoms:
  • skin reaction with fever
  • sore mouth or throat
  • blistering or peeling of your skin or in the mouth


• Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have kidney failure and the need for dialysis treatment, as well as an abnormal heartbeat. Your healthcare provider may do blood tests to check you for TLS. Call your healthcare provider or get emergency medical help right away if you develop any of these symptoms during treatment with DASATINIB:
  • nausea
  • vomiting
  • weakness
  • swelling
  • shortness of breath
  • muscle cramps
  • seizures


• Slowing of growth and development in children: Effects on bone growth and development in children have happened with DASATINIB and can sometimes be severe. Your healthcare provider will monitor your child's bone growth and development during treatment with DASATINIB. Get medical help right away if your child develops bone pain.


• Liver problems: DASATINIB can cause liver problems. People who have had liver problems in the past may be at risk for getting liver problems with DASATINIB. Your healthcare provider will monitor liver function as needed during the treatment with DASATINIB. Call your healthcare provider or get medical help right away if you develop any symptoms of liver problems, including: stomach area (abdominal) pain, yellowing of your skin or white part of your eyes, loss of appetite, bleeding, bruising, or dark "tea-colored" urine.

Most common side effects

The most common side effects of DASATINIB in adults and children receiving DASATINIB alone include:

• diarrhea
• headache
• skin rash
• shortness of breath
• tiredness
• nausea
• muscle pain

The most common side effects of DASATINIB in children receiving DASATINIB with chemotherapy include:

• swelling, pain, and redness of the lining of your mouth, throat, stomach, and bowel (mucositis)
• low white blood cell counts with fever
• fever
• diarrhea
• nausea
• vomiting
• muscle pain
• stomach-area (abdominal) pain
• cough
• headache
• rash
• tiredness
• constipation
• abnormal heart rate
• high blood pressure (hypertension)
• swelling
• infections
• low blood pressure
• decreased appetite
• allergic reactions
• shortness of breath
• nosebleed
• numbness or tingling of your hands and feet
• feeling confused or disoriented

DASATINIB may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of DASATINIB. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

You are encouraged to report negative side effects of prescription drugs. To report SUSPECTED ADVERSE REACTIONS, contact Apotex at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please see the full Prescribing Information (20/50/70/100 mg or 80/140 mg) and Patient Information (20/50/70/100 mg or 80/140 mg) for DASATINIB TABLETS corresponding to your prescribed dosage.