PHYRAGO™ (dasatinib)

• have problems with your immune system
• have heart problems, including a condition called congenital long QT syndrome
• have low potassium or low magnesium levels in your blood
• have liver problems
• are pregnant or plan to become pregnant. PHYRAGO can harm your unborn baby.
  • Females who can become pregnant:
  • • You should not become pregnant during treatment with PHYRAGO.
    • You should use effective birth control (contraception) during treatment and for 30 days after your last dose of PHYRAGO.
    • Talk to your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with PHYRAGO.
  • 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 PHYRAGO.
    • Your female partner should call her healthcare provider if she becomes pregnant or thinks she is pregnant during your treatment with PHYRAGO.
• are breastfeeding or plan to breastfeed. It is not known if PHYRAGO passes into your breast milk. You should not breastfeed during treatment and for 2 weeks after your last dose of PHYRAGO.

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

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

PHYRAGO may cause serious side effects, including:

• 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 PHYRAGO. Call your healthcare provider right away if you have a fever or any signs of an infection during treatment with PHYRAGO.
• 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 get any of these symptoms during treatment with PHYRAGO:
  • 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. PHYRAGO 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 PHYRAGO:
  • chest pain
  • shortness of breath
  • feeling like your heart is beating too fast or you feel abnormal heart beats
  • vision changes that may last for a short time
  • slurred speech
• Pulmonary Arterial Hypertension (PAH). PHYRAGO may cause high blood pressure in the vessels of your lungs. PAH may happen at any time during your treatment with PHYRAGO. Your healthcare provider should check your heart and lungs before and during treatment with PHYRAGO. Call your healthcare provider right away if you have shortness of breath, tiredness, or swelling all over your body (fluid retention).
• Severe skin reactions. PHYRAGO may cause skin reactions that can sometimes be severe. Get medical help right away if you get a skin reaction with fever, sore mouth or throat, or 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, and 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 PHYRAGO:
  • nausea
  • shortness of breath
  • vomiting
  • muscle cramps
  • weakness
  • seizures
  • swelling
• 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. PHYRAGO can cause liver problems. People who have had liver problems in the past may be at risk for getting liver problems with PHYRAGO. Your healthcare provider will monitor your liver function as needed during treatment with PHYRAGO. Call your healthcare provider or get medical help right away if you develop any symptoms of liver problems, including:
  • stomach-area (abdominal) pain
  • bleeding
  • yellowing of your skin or white part of your eyes
  • bruising
  • loss of appetite
  • dark “tea-colored” urine

The most common side effects in adults receiving dasatinib alone include:

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

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

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

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.